SPECIFI-PSO (DRI17849)
Research type
Research Study
Full title
A Phase 2, International, Multicenter, Randomized, Doubleblind, Placebo-controlled, Dose-ranging study of Efficacy and Safety of SAR441566 in Adults with Moderate to Severe Plaque Psoriasis
IRAS ID
1008849
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2023-503911-14
Research summary
This is a Randomized, Doubleblind, Placebo-controlled, Dose-ranging study of Efficacy and Safety of SAR441566 in Adults with Moderate to Severe Plaque Psoriasis.
Plaque psoriasis is a common form of psoriasis. It is named after the dry skin lesions it causes, also known as plaques. These can be itchy and sore with white or silver scales. In severe cases they may crack and bleed.
SAR441566 is an orally administered medicine that is being tested to see if it can help in the treatment of plaque psoriasis.
The purpose of this study is to evaluate the efficacy, suitable dose and safety of SAR441566 in treating plaque psoriasis.
Participation is up to 18 weeks (28 day screening period, 12 week treatment period and a 2 week follow-up period and will involve approximately 7 visits to the study centre.
A total of approximately 207 participants will take part in this study in different countries around the world. Participants will be split into two groups, Group A and Group B, based on their previous psoriasis treatment.
Group A will have approximately 144 participants that will be assigned to one of 6 treatment groups, each treatment group with have approximately 24 participants. Five of the treatment groups consist of different doses of SAR441566 and one treatment group consists of placebo (a dummy drug containing no active ingredients).
Group B will have approximately 63 participants that will be assigned to 1 of 4 treatment groups. 54 participants will be assigned to 1 of three SAR441566 treatment groups, each will contain 18 participants. 9 participants will be assigned to the placebo treatment group.
Participants will receive study drug (SAR441566 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, 'clinical/skin assessments, ECG, questionnaires, photography, blood and urine samples.
The sponsor of this study is Sanofi-Aventis Recherche & DéveloppementREC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0920
Date of REC Opinion
14 Dec 2023
REC opinion
Further Information Favourable Opinion