Safety and efficacy of low-dose interleukin-2 therapy in chronic inflammatory barrier diseases (IL-2-ID)

Phase 1

Conditions: Mucous Membrane Pemphigoid, Primary Sclerosing Cholangitis (PSC), Pemphigus vulgaris / foliaceus, Polymyositis/ Dermatomyositis
MedDRA version: 20.0Level: LLTClassification code: 10057069Term: Pemphigus foliaceus Class: 10040785
MedDRA version: 20.1Level: LLTClassification code: 10036732Term: Primary sclerosing cholangitis Class: 10019805
MedDRA version: 20.0Level: LLTClassification code: 10052802Term: Pemphigus vulgaris Class: 10040785
MedDRA version: 20.0Level: PTClassification code: 10012503Term: Dermatomyositis Class: 100000004858
MedDRA version: 20.0Level: PTClassification code: 10036102Term: Polymyositis Class: 100000004859
MedDRA version: 25.0Level: PTClassification code: 10087064Term: Mucous membrane pemphigoid Class: 100000004858
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: CTIS2023-510297-14-00

Lead Sponsor: niversitaetsklinikum Schleswig-Holstein AöR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 112

Inclusion Criteria

Participants with pemphigus vulgaris / foliaceus (PV/PF) and having mild to moderate disease activity as defined by a PDAI = 6 and = 45., Participants with mucous membrane pemphigoid (MMP) and having mild to moderate disease activity as defined by a MMPDAI of = 6 and = 45., Participants with polymyositis (PM) or dermatomyositis (DM) and having elevated plasma concentrations of the creatine kinase (CK) of = 300 U/L and = 3000 U/L. Concomitant diagnoses of other rheumatic diseases (overlaps) are allowed., Participants with primary sclerosing cholangitis (PSC) and having elevated plasma concentrations of the alkaline phosphatase (AP) of = 1.5 times above the upper limit of normal. Concomitant diagnosis of inflammatory bowel diseases is allowed., Age of participants: = 18 years and = 80 years.

Exclusion Criteria

Severe impairment of vital organ or life-threatening disease, Chronically active infectious diseases