B7931028_Evaluate the Efficacy and Safety Profile of PF-06700841_SLE
Research type
Research Study
Full title
A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF 06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
IRAS ID
270097
Contact name
David D'Cruz
Contact email
david.d'cruz@kcl.ac.uk
Sponsor organisation
Pfizer Inc.
Eudract number
2018-004175-12
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
MUSC 40617, Registration with NIHR:
Duration of Study in the UK
1 years, 5 months, 17 days
Research summary
This study will explore the effects of the study drug, PF 06700841 tablets, at different doses, compared against a placebo tablet to find out if any daily dose is better for treating Lupus (Systemic Lupus Erythematosus (SLE)) than placebo.
Lupus is a long-term condition causing inflammation to the joints, skin and other organs. The purpose of the study is to determine the safety and effectiveness of PF-06700841 in patients with SLE. Such participants with SLE are currently being managed with multiple medications, including anti-malarial drugs, immunosuppressives (inhibit or prevent activity of the immune system) and corticosteroids (agents that suppress or modulate the immune system). These medications, in protocol defined combinations, will be allowed as standard of care background treatment during the study. As study intervention will be supplementary therapy to participant’s standard of care, no participants will receive placebo alone. After an up to 5-week screening period, eligible participants will be randomly allocated in a 1:2:2:2 ratio such that participants will receive either 15mg, 30mg and 45mg of PF-06700841 once a day or placebo every day for 52 weeks. Participants will not know what medication they are receiving throughout the study treatment period in order to maintain the study blind.
There will be about 448 people taking part in this study across 25 countries and approximately 165 different study sites worldwide. It is expected that there will be approximately 4 sites in the UK and approximately 11 patients will be recruited in the UK. The participants will be in the study for approximately 60 weeks. They will need to visit the study site about 18 times during the study. These visits will occur weekly for the first 2 weeks, every 2 weeks for the first 8 weeks and then every 4 weeks for the remainder of the study.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0673
Date of REC Opinion
30 Dec 2019
REC opinion
Further Information Favourable Opinion