Dose-ranging study to evaluate the efficacy, safety of DC-806 in moderate to severe plaque psoriasis
Research type
Research Study
Full title
A Multicenter, Randomized, Double-blind, Placebo controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of DC-806 in Participants with Moderate to Severe Plaque Psoriasis
IRAS ID
1007535
Contact name
Paula Opal
Contact email
Sponsor organisation
Dice Therapeutics Inc.
Research summary
This is a randomized, double-blind, placebo controlled, parallel-group, dose-ranging study to evaluate the efficacy and safety of DC-806 in participants with moderate to severe plaque psoriasis.
Psoriasis is a skin disease that causes a rash with itchy, scaly patches, most commonly on the knees, elbows, trunk, and scalp. Treatments that are currently available can help manage symptoms of psoriasis. Further, lifestyle changes may help people to better cope with psoriasis. Researchers are looking for a better way to treat psoriasis.
DC-806 is an orally administered medicine that is being tested to see if it can help in the treatment of psoriasis. It is believed that DC-806 can block the inflammatory proteins that cause psoriasis.
The purpose of this study is to understand how well DC-806 works and how safe it is for participants with psoriasis for whom the usual treatments (e.g, special light treatment to the skin and oral or injectable medicines) do not seem to work.
Participation is for up to 20 weeks (28-day screening period, a 12-week treatment period and a 4-week follow-up period), and will involve approximately 8 visits to the study centre.
A total of approximately 225 participants will take part in this study in different countries around the world. All participants will be assigned to one of 5 treatment groups, each group with approximately 45 participants. Four of the treatment groups consist of different doses of DC-806 and 1 treatment group consists of placebo.
Participants will receive study drug (DC-806 or placebo) tablets to be taken at home orally for 84 days during the treatment period.
Procedures for this study include vital signs, physical examination, questionnaires, blood and urine samples.
The sponsor of this study is DICE Therapeutics, Inc.REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0157
Date of REC Opinion
1 Sep 2023
REC opinion
Further Information Favourable Opinion