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Safety and efficacy of low-dose interleukin-2 therapy in chronic inflammatory barrier diseases (IL-2-ID)
EU CTIS ID: 2023-510297-14-00
What this study is testing
The primary objective of this exploratory, indication-finding basket trial is to evaluate and compare the safety and the relationship between the magnitude of Treg responses and clinical responses elicited by low-dose IL-2 therapy in participants with active Pemphigus vulgaris / foliaceus (PV/PF), Mucous Membrane Pemphigoid (MMP), Polymyositis/ Dermatomyositis (PM/DM) and Primary Sclerosing Cholangitis (PSC).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Severe impairment of vital organ or life-threatening disease
- Chronically active infectious diseases
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.