Sirolimus as treatment for patients with sarcoidosis.

Phase 1

• Conditions: Sarcoidosis with cutaneous affections; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-004930-27-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-20
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1)Patients of full age (18 – 80 years old) that fulfil the ATS/ERS/WASOG diagnostic criteria for sarcoidosis and have a progressive disease and skin involvement (more than 3x3cm).
2)Histologically proven sarcoidosis, diagnosed = 6 year prior to screening
3)If immunosuppressants are taken at the time of screening, doses of these medications have to remain stable for =1 month (no additional immunosuppressants, no major alterations of the dosages) prior to the screening visit. During the study, background medication regimen and doses should remain stable until month 8, when tapering of oral glucocorticosteroids can be started.
4)Written informed consent
5)Compliance of the patients to follow instructions and appointments of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1)Hypersensitivity / intolerance against sirolimus or other components of the medication, patients with an allergy against peanuts or soya
2)Pregnancy, Lactation
3)Concurrent malignancy
4)Chronic or serious infections within 2 months prior screening
5)Transplantation of an organ in the medical history

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified