Dapirolizumab pegol (DZP) ( DrugBank: Dapirolizumab pegol )


1 disease
IDDisease name (Link within this page)Number of trials
49Systemic lupus erythematosus6

49. Systemic lupus erythematosus


Clinical trials : 993 Drugs : 702 - (DrugBank : 184) / Drug target genes : 116 - Drug target pathways : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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PhaseCountries
1EUCTR2015-004457-40-PL
(EUCTR)
04/11/201602/09/2016A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given.A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTSWITH MODERATELY TO SEVERELY ACTIVE SYSTEMICLUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
2EUCTR2015-004457-40-ES
(EUCTR)
10/10/201605/08/2016A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given.A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS. SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS.
MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
3EUCTR2015-004457-40-HU
(EUCTR)
20/09/201613/07/2016 A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
4EUCTR2015-004457-40-DE
(EUCTR)
19/09/201622/06/2016 A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
5EUCTR2015-004457-40-BG
(EUCTR)
13/09/201603/08/2016 A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 19.1;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
6NCT02804763
(ClinicalTrials.gov)
June 2, 201614/6/2016A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus ErythematosusA Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE)Drug: Placebo;Drug: Dapirolizumab pegol (DZP)UCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll182Phase 2United States;Bulgaria;Chile;Colombia;Germany;Hungary;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Ukraine