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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1275-0915 | Registry Identifier | ICTRP | |
| 2022-000850-27 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR441566 | Experimental | Repeated dose of SAR441566 administered twice a day (BID) for 4 weeks under fed conditions |
|
| Placebo | Placebo Comparator | Repeated dose of matching placebo administered twice a day (BID) for 4 weeks under fed condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR441566 | Drug | Repeated dose of SAR441566 administered twice a day (BID) for 4 weeks under fed conditions |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAE) including SAE and AESI | Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including SAE and AESI | Up to 69 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in the target lesion severity score (TLSS) to weeks 2 and 4 | TLSS consists of a sum score of 3 clinical severity parameters (scaling, erythema, plaque elevation/induration; each graded on a 5-point severity scale; 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe/very severe) with a sum score ranging between 0 and 12 points | Baseline to week 4 |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number :2760001 | Berlin | 10117 | Germany |
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| Label | URL |
|---|---|
| PDY16918 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo | Drug | Repeated dose of matching placebo administered twice a day (BID) for 4 weeks under fed condition |
|