BOS161721 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス4

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2018-000305-23-RO
(EUCTR)
30/09/201909/06/2022NoA Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: BOS161721
Product Code: BOS161721
INN or Proposed INN: Not known
Other descriptive name: IMMUNOGLOBULIN G
Boston Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
156Phase 2United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia
2EUCTR2018-000305-23-BG
(EUCTR)
20/03/201912/11/2018A Phase 1b/2 Study of BOS161721 in Systemic Lupus Erythematosus (SLE) PatientsA Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: BOS161721
Product Code: BOS161721
INN or Proposed INN: Not known
Other descriptive name: IMMUNOGLOBULIN G
Boston Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
156Phase 2United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia
3EUCTR2018-000305-23-HU
(EUCTR)
07/02/201928/11/2018NoA Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care Systemic lupus erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: BOS161721
Product Code: BOS161721
INN or Proposed INN: Not known
Other descriptive name: IMMUNOGLOBULIN G
Boston Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
156Phase 2United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia
4NCT03371251
(ClinicalTrials.gov)
February 7, 20188/12/2017Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of CareA Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of CareSystemic Lupus ErythematosusDrug: BOS161721;Drug: PlaceboBoston PharmaceuticalsNULLCompleted18 Years70 YearsAll143Phase 1/Phase 2United States;Argentina;Bulgaria;Colombia;Georgia;Hungary;Mexico;Peru;Philippines;Poland;Romania;Ukraine