A Study to Investigate Safety, Tolerability and Clinical Response With SAR441566 Compared With Placebo in Participants With Mild to Moderate Psoriasis
Study Purpose
This is a parallel, Phase 1, single center, 2-arm, double-blind, randomized, placebo-controlled with a ratio 2 active: 1 placebo study for treatment of mild to moderate psoriasis participants. Approximately 36 participants (24 in the SAR441566 group and 12 in the placebo group) are to be enrolled to have a total of 33 evaluable participants (22 in the SAR441566 group and 11 in the placebo group). The objective of this study is primarily to evaluate the tolerability and safety and secondarily the clinical response over 4-week oral treatment with SAR441566 in participants with mild to moderate psoriasis. The clinical response is measured by the relative change from baseline in Total Lesion Severity Score (TLSS). The study comprises an up to 4-week screening period, a 4-week treatment period with SAR441566 or placebo. The end-of-study visit will be carried out 10 ±3 days after the last investigational medicinal product administration. The frequency of visits is once a week during the treatment period.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 65 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05453942 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 1 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Sanofi |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Clinical Sciences & Operations |
Principal Investigator Affiliation | Sanofi |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Germany |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Psoriasis |
Contact a Trial Team
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