Phase 2 Study to Evaluate PF-06823859 in Adults With Active CLE or SLE
Research type
Research Study
Full title
A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE CLINICAL EFFECT, PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY PROFILE OF PF-06823859 IN ADULT PARTICIPANTS WITH ACTIVE CLE OR SLE WITH CUTANEOUS MANIFESTATIONS
IRAS ID
1008137
Contact name
Claudia Brennan
Contact email
Sponsor organisation
Pfizer Inc.
Research summary
This is a phase 2 study for adult participants who has Cutaneous Lupus Erythematosus (CLE) or Systemic Lupus Erythematosus with Cutaneous manifestations (SCLE). This study will explore the effects (safety and control of participants disease) of study drug, PF-06823859, an anti-interferon beta monoclonal antibody, compared against a placebo to find out if the study drug works better than placebo for treating CLE/SCLE. The purpose of research is to gather information to advance science and medicine and does not replace regular medical care.
Participants will be asked to take part in the study for about 65 weeks. They will be assigned to receive the study drug, or a placebo (a placebo does not contain any active ingredients) with chances to receive an active study drug twice likely compared to receive a placebo. The drugs will look alike.
Participants will be asked to provide biological samples (such as blood, urine, salivary, and skin biopsy) and undergo procedures that might be different from a regular medical examination. This study will involve an up to 5-week screening period. The study doctor will determine whether participants are eligible for the study. This study will require them to visit the study doctor every 4 weeks for initial 20 weeks followed by every 8 weeks with a telephone contact in-between to undergo study procedures and to provide information about their health. At Week 16, participants may receive either an active study drug or placebo based on their initial study drug assignment and changes in their disease activity as assessed by their doctor.
These study procedures will include physical exam, vital signs (temperature, blood pressure, pulse rate and respiratory rate), lab tests, biological sample collections, CLE/SCLE disease activity assessments.REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0828
Date of REC Opinion
17 Nov 2023
REC opinion
Further Information Favourable Opinion