GS-5745 ( DrugBank: GS-5745 )


4 diseases
IDDisease name (Link within this page)Number of trials
46Malignant rheumatoid arthritis5
96Crohn disease8
97Ulcerative colitis18
299Cystic fibrosis4

46. Malignant rheumatoid arthritis


Clinical trials : 4,356 Drugs : 2,567 - (DrugBank : 415) / Drug target genes : 192 - Drug target pathways : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-000897-39-DE
(EUCTR)
10/05/201727/10/2016An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis. Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany
2EUCTR2016-000897-39-BE
(EUCTR)
03/04/201702/02/2017An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis. Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany
3EUCTR2016-000897-39-HU
(EUCTR)
09/01/201719/10/2016An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis. Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Taiwan;Hungary;Mexico;Belgium;Australia;Germany
4NCT02862574
(ClinicalTrials.gov)
December 15, 20168/8/2016Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid ArthritisEvaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisDrug: Andecaliximab;Drug: Placebo;Drug: Methotrexate;Drug: TNF InhibitorGilead SciencesNULLTerminated18 Years80 YearsAll15Phase 2United States;Australia;Hungary;Taiwan
5NCT02176876
(ClinicalTrials.gov)
August 201425/6/2014Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid ArthritisA Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: GS-5745;Drug: Placebo to match GS-5745Gilead SciencesNULLCompleted18 Years70 YearsBoth18Phase 1Czech Republic;Hungary

96. Crohn disease


Clinical trials : 2,442 Drugs : 1,278 - (DrugBank : 248) / Drug target genes : 142 - Drug target pathways : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-001249-10-IS
(EUCTR)
12/04/201602/03/2016An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Germany;Iceland;United Kingdom;New Zealand
2EUCTR2015-001249-10-GB
(EUCTR)
11/12/201506/10/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;Italy;New Zealand;United Kingdom
3EUCTR2015-001249-10-IT
(EUCTR)
11/11/201521/02/2018An investigational study to assess the safety and effectiveness of a newinvestgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, MulticenterStudy Evaluating the Safety and Efficacy of GS-5745 in Subjects withModerately to Severely Active Crohn's Disease - GS-US-395-1663 Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GS-5745
Product Code: nessuno
GILEAD SCIENCES INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;Italy
4EUCTR2015-001249-10-DE
(EUCTR)
02/11/201514/08/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand
5EUCTR2015-001249-10-CZ
(EUCTR)
01/10/201514/08/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Hungary;Czech Republic;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand
6EUCTR2015-001249-10-HU
(EUCTR)
22/09/201510/08/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand
7EUCTR2015-001249-10-ES
(EUCTR)
16/09/201511/09/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's diseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn?s Disease Crohn's Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
175Phase 2United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand
8NCT02405442
(ClinicalTrials.gov)
April 30, 201527/3/2015Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's DiseaseA Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Andecaliximab;Drug: PlaceboGilead SciencesNULLTerminated18 Years75 YearsAll187Phase 2United States;Australia;Canada;Czechia;France;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom;Czech Republic;Iceland

97. Ulcerative colitis


Clinical trials : 2,630 Drugs : 1,459 - (DrugBank : 265) / Drug target genes : 144 - Drug target pathways : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-005217-24-ES
(EUCTR)
29/06/201610/11/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis - NA Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
2EUCTR2014-005217-24-DE
(EUCTR)
24/05/201623/10/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
3EUCTR2014-005217-24-IS
(EUCTR)
10/05/201628/04/2016An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Germany;Iceland;New Zealand;Sweden
4EUCTR2014-005217-24-HR
(EUCTR)
29/03/201628/04/2016An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
5EUCTR2014-005217-24-SE
(EUCTR)
02/03/201603/11/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
6EUCTR2014-005217-24-BE
(EUCTR)
14/01/201626/10/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
7EUCTR2014-005217-24-BG
(EUCTR)
05/01/201619/10/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
8EUCTR2014-005217-24-CZ
(EUCTR)
22/12/201506/10/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
9EUCTR2014-005217-24-NL
(EUCTR)
17/12/201526/10/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
10EUCTR2014-005217-24-GB
(EUCTR)
27/11/201522/10/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3United States;Belarus;Philippines;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Croatia;Romania;Bulgaria;Iceland;Germany;New Zealand;Sweden
11EUCTR2014-005217-24-HU
(EUCTR)
19/11/201522/09/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
12EUCTR2014-005217-24-IE
(EUCTR)
12/11/201511/12/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
13EUCTR2014-005217-24-SK
(EUCTR)
12/11/201507/10/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
14EUCTR2014-005217-24-LV
(EUCTR)
06/11/201503/11/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
15EUCTR2014-005217-24-AT
(EUCTR)
06/11/201522/10/2015An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
1600Phase 2;Phase 3Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden;Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain
16NCT02520284
(ClinicalTrials.gov)
September 20157/8/2015Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative ColitisA Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisBiological: Andecaliximab;Biological: PlaceboGilead SciencesNULLTerminated18 Years75 YearsAll165Phase 2/Phase 3United States;Australia;Belgium;Bulgaria;Canada;Czechia;France;Hungary;Ireland;Italy;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Switzerland;Taiwan;Ukraine;United Kingdom;Austria;Croatia;Czech Republic;Germany;Hong Kong;Iceland;Israel;Serbia;Spain;Sweden
17NCT02209987
(ClinicalTrials.gov)
August 20144/8/2014Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy AdultsA Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy SubjectsUlcerative ColitisDrug: GS-5745 SC;Drug: GS-5745 IVGilead SciencesNULLCompleted18 Years45 YearsBoth28Phase 1New Zealand
18NCT01831427
(ClinicalTrials.gov)
March 20138/4/2013Evaluating the Safety, Pharmacokinetics and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative ColitisA Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: GS-5745;Drug: Placebo to match GS-5745Gilead SciencesNULLCompleted18 Years65 YearsAll74Phase 1United States;Belgium;Canada;Hungary;Moldova, Republic of;Netherlands;Romania

299. Cystic fibrosis


Clinical trials : 1,695 Drugs : 1,527 - (DrugBank : 268) / Drug target genes : 111 - Drug target pathways : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02759562
(ClinicalTrials.gov)
November 4, 201629/4/2016Effect of Andecaliximab on FEV1 in Adults With Cystic FibrosisA Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic FibrosisCystic FibrosisDrug: Andecaliximab;Drug: PlaceboGilead SciencesNULLTerminated18 YearsN/AAll6Phase 2Australia;France;Germany;Spain;United Kingdom;Belgium;Canada;Ireland;United States
2EUCTR2015-002192-23-ES
(EUCTR)
16/08/201609/06/2016An investigational study to assess the effect of GS-5745 on adult patients with Cystic Fibrosis.A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis. Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Canada;Belgium;Spain;Ireland;Australia;Germany;United Kingdom
3EUCTR2015-002192-23-BE
(EUCTR)
18/07/201618/05/2016An investigational study to assess the effect of GS-5745 on adult patients with Cystic FibrosisA Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Canada;Spain;Belgium;Ireland;Australia;Germany;United Kingdom
4EUCTR2015-002192-23-DE
(EUCTR)
03/06/201611/05/2016An investigational study to assess the effect of GS-5745 on adult patients with Cystic FibrosisA Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Canada;Belgium;Spain;Ireland;Australia;Germany;United Kingdom