Study on Low-Dose Aldesleukin for Patients with Pemphigus, Mucous Membrane Pemphigoid, Polymyositis, Dermatomyositis, and Primary Sclerosing Cholangitis
This clinical trial is investigating the safety and effectiveness of low-dose Interleukin-2 (also known as aldesleukin or IL-2) for treating several chronic inflammatory diseases, including mucous membrane pemphigoid. The study takes place in Germany and uses a randomized, double-blind design to ensure unbiased results.
Inclusion criteria: Participants must be between 18 and 80 years old and have one of the conditions being studied. For those with mucous membrane pemphigoid specifically, the disease activity should be mild to moderate, with a score between 6 and 45 on the MMPDAI scale, which measures disease severity.
Exclusion criteria: Pregnant or breastfeeding women cannot participate. The trial also excludes people with a history of severe allergic reactions to similar treatments, active infections requiring treatment, recent cancer diagnosis (within the last five years, except certain skin cancers), significant heart problems, uncontrolled high blood pressure, severe liver or kidney disease, recent participation in other investigational drug studies, history of drug or alcohol abuse within the past year, certain autoimmune diseases not being studied, and those unable to comply with study procedures.
Focus and goals: The trial aims to evaluate how low-dose IL-2 therapy affects the immune system and whether it leads to improvements in disease symptoms. Researchers will monitor participants' immune responses and changes in their condition over an eight-week treatment period. The medication is administered as a subcutaneous injection, meaning it is given under the skin. The study specifically looks at whether this treatment can safely increase the number of regulatory T cells, which help control inflammation in the body.
Investigational drug: Interleukin-2 is an immunomodulatory medication that works by binding to specific receptors on T cells, promoting their growth and activity. In this trial, it is used in low doses to help manage chronic inflammatory conditions by modulating the immune system.
Study on Rituximab and Cyclophosphamide for Patients with Severe Mucous Membrane Pemphigoid
This clinical trial, conducted in France, compares two different treatment approaches for severe mucous membrane pemphigoid. The study examines whether rituximab or cyclophosphamide, both used in combination with dapsone, is more effective in achieving remission over a 12-month period.
Inclusion criteria: Participants must be between 18 and 85 years old with a confirmed diagnosis of severe mucous membrane pemphigoid. The condition is considered severe if it involves eye disease that threatens sight, narrowing of the throat or food pipe that could be life-threatening, involvement of areas that could scar and narrow, more than one mucous membrane area affected, severe mouth involvement, or skin or mouth involvement that hasn't improved with previous treatments. Patients must have up-to-date vaccinations, be able to follow study procedures, and be part of a social security system. Women of childbearing age must use effective birth control during the study and for 12 months after treatment, and men must use condoms during the same period.
Exclusion criteria: The trial excludes patients who do not have severe forms of the condition or who fall outside the specified age range of 18 to 85 years.
Focus and goals: The study aims to determine which treatment is more effective in reducing disease activity and improving quality of life for those with severe disease. Participants will be randomly assigned to receive either rituximab (given as an intravenous infusion at 500 mg) or cyclophosphamide (taken orally at 50 mg), both combined with dapsone. Regular follow-up visits will monitor health and treatment effects through physical examinations, blood tests, and quality of life questionnaires at 3, 6, 12, 18, and 24 months. The study will also measure changes in specific antibodies associated with the disease to better understand how treatments affect the immune response.
Investigational drugs: Rituximab is a monoclonal antibody administered through intravenous infusion that targets and reduces B-cells involved in the disease process. Cyclophosphamide is an alkylating agent taken orally that interferes with cell DNA to reduce immune system activity. Dapsone is used alongside cyclophosphamide to reduce inflammation and is often prescribed for skin conditions.
Germany