drugset / Trial / NCT05458492

Sirolimus in Cutaneous Sarcoidosis

NCT05458492 ↗

Phase 2 Not yet recruiting 10 enrolled Assistance Publique - Hôpitaux de Paris
NaSingle-groupOpen-labelTreatment

Summary

Sarcoidosis is a multisystemic disease of unknown etiology characterized by the presence of epithelioid granulomas without caseous necrosis in the organs involved. Sarcoidosis cutaneous lesions can be severe. There is no recommendation for the treatment of cutaneous sarcoidosis. A recent study highlights the potential efficacy of mTOR inhibitors in the treatment of sarcoidosis granulomas. The hypothesis is that sirolimus could be effective for sarcoidosis treatment, especially for cutaneous lesions. The main objective of this study is to evaluate sirolimus efficacy on cutaneous sarcoidosis of the face. The main evaluation criteria is the percentage of patients with a significant clinical response (relative decrease in "facial SASI" ≥ 25%) at week 16 of treatment.

Timeline

Start
2022-07
Primary completion
2024-05
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule 2 mg Oral

Indications