Anti-CD3 Monoclonal antibody ( DrugBank: Anti-CD3 )


2 diseases
IDDisease name (Link within this page)Number of trials
96Crohn disease4
97Ulcerative colitis20

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
1NCT05028946
(ClinicalTrials.gov)
May 1, 202224/8/2021A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's DiseaseA Phase IB Multiple Ascending Dose Study of Safety and Tolerability of Orally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Subjects With Moderate to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: ForalumabTiziana Life Sciences, PLCNULLWithdrawn18 Years70 YearsAll0Phase 1NULL
2EUCTR2004-004387-72-AT
(EUCTR)
11/10/200509/06/2005A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/AA Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A Crohn’s disease (CD) in patients with at least one perianal fistula.
MedDRA version: 7.1;Level: LLT;Classification code 10011401
Product Name: Visilizumab
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: Anti-CD3 Monoclonal antibody
Protein Design Labs, Inc.NULLNot RecruitingFemale: yes
Male: yes
18Phase 2Austria;Germany
3EUCTR2004-004387-72-DE
(EUCTR)
03/06/200507/01/2005A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/AA Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A Crohn’s disease (CD) in patients with at least one perianal fistula.
MedDRA version: 7.1;Level: LLT;Classification code 10011401
Product Name: Visilizumab
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: Anti-CD3 Monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
18Phase 2Germany
4EUCTR2004-004388-31-DE
(EUCTR)
03/06/200507/01/2005A Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/AA Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/A Moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn’s disease (CD).
MedDRA version: 7.1;Level: LLT;Classification code 10011401
Product Name: Visilizumab
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: Anti-CD3 Monoclonal antibody
PDL BioPharma, IncNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Germany

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
1EUCTR2005-003707-37-BE
(EUCTR)
25/05/200718/12/2006A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Belgium;Austria
2EUCTR2005-003707-37-AT
(EUCTR)
09/05/200703/01/2007A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Belgium;Austria
3EUCTR2005-003482-17-GB
(EUCTR)
26/02/200701/02/2006A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2United Kingdom;Spain;Ireland;Italy;Greece
4EUCTR2005-003482-17-GR
(EUCTR)
30/01/200724/11/2006A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ DA Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ D Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United Kingdom;Spain;Ireland;Italy;Greece
5EUCTR2005-003481-42-GR
(EUCTR)
30/01/200724/11/2006A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ RA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece
6EUCTR2005-003481-42-ES
(EUCTR)
26/05/200615/03/2006A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab.A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab. Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Colitis ulcerosa refractaria a esteróides intravenonsos
MedDRA version: 8.0;Level: LLT;Classification code 10045265
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Hungary;Germany;Czech Republic;Slovakia;Ireland;Spain;Italy;Greece
7EUCTR2005-003482-17-ES
(EUCTR)
26/05/200615/03/2006A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisEstudio fase 2, aleatorizado, doble ciego, multicéntrico, de exploración de dosis de Visilizumab en sujetos con colitis ulcerosa refractaria a esteróides intravenosos.A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisEstudio fase 2, aleatorizado, doble ciego, multicéntrico, de exploración de dosis de Visilizumab en sujetos con colitis ulcerosa refractaria a esteróides intravenosos. Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 8.0;Level: LLT;Classification code 10045265
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United Kingdom;Ireland;Spain;Italy;Greece
8EUCTR2005-003481-42-SK
(EUCTR)
21/04/200625/11/2005A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
Protein Design Labs, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany
9EUCTR2005-002063-87-HU
(EUCTR)
04/04/200602/05/2007A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
Protein Design Labs, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2/3Hungary;Germany;Czech Republic;Belgium
10EUCTR2005-003481-42-IE
(EUCTR)
04/04/200610/01/2006A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, IncNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany
11EUCTR2005-003481-42-HU
(EUCTR)
04/04/200628/11/2005A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ RA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece
12EUCTR2005-002063-87-DE
(EUCTR)
22/03/200629/11/2005A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 2/3Hungary;Czech Republic;Germany;Belgium
13EUCTR2005-003481-42-DE
(EUCTR)
22/03/200629/11/2005A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ RA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Hungary;Czech Republic;Slovakia;Germany;Spain;Ireland;Italy;Greece
14EUCTR2005-002063-87-SK
(EUCTR)
16/03/200623/11/2005A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany
15EUCTR2005-003482-17-IE
(EUCTR)
03/03/200610/01/2006A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 8.0;Level: LLT;Classification code 10045265
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2Greece;Spain;Ireland;Italy;United Kingdom
16EUCTR2005-003481-42-CZ
(EUCTR)
16/02/200628/11/2005A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ RA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365
Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Hungary;Germany;Slovakia;Czech Republic;Spain;Ireland;Italy;Greece
17EUCTR2005-002063-87-CZ
(EUCTR)
16/02/200628/11/2005A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
PDL BioPharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2/3Hungary;Germany;Czech Republic;Belgium
18EUCTR2005-002063-87-BE
(EUCTR)
09/02/200624/11/2005A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
Protein Design Labs, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2/3Hungary;Germany;Czech Republic;Belgium
19EUCTR2005-003481-42-AT
(EUCTR)
04/01/200630/11/2005A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyA Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
Protein Design Labs, IncNULLNot RecruitingFemale: yes
Male: yes
80Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany
20EUCTR2005-002063-87-AT
(EUCTR)
28/12/200523/11/2005A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisA Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody
Protein Design Labs, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2/3Hungary;Czech Republic;Belgium;Austria;Germany