WHO ICTRP trial
A clinical trial undertaken around the world in adult patients with lupus…
EUCTR2015-004457-40-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2015-004457-40-DE |
|---|---|
| Public title | 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. |
| Scientific title | 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 |
| Primary sponsor | UCB Biopharma SPRL |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany |
| Conditions | 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… |
| Interventions | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Dapirolizumab pegol Current Sponsor code: DZP Other descriptive name: CDP7657… |
| Registration date | Jun 22, 2016 |
| Target size | 160 |
| Secondary IDs | SL0023 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: