Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized Scleroderma (NCT04200755) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized Scleroderma
Germany45 participantsStarted 2020-05-19
Plain-language summary
The DupiMorph study evaluates the efficacy of Dupilumab in localized scleroderma patients. Dupilumab is approved in the US and EU for the treatment of moderate/severe atopic dermatitis and since 2018 in the US for severe asthma therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is a male or female ≥18 years of age on the day the study informed consent is signed
* Out-patient status
* Caucasian
* Morphea (plaque type) or Generalized localized scleroderma (affecting at least three anatomic sites)
* At least one lesions with lilac ring (active phase of the disease);
* Activity of LS within the last 12 month (as defined by progression of size or new developing plaque)
* For women of childbearing potential: negative pregnancy test at Visit 1
* For women of childbearing potential: Use of effective method of contraception from 4 weeks prior to enrolment, throughout study treatment until 12 weeks after the last IMP dose.
* Written informed consent signed
Exclusion Criteria:
* Systemic immunosuppressive therapy or UV therapy less than 3 months before enrollment.
* Participation in another trial of IMPs or devices parallel to, or less than 6 months before or previous participation in this trial
* Pregnancy or breastfeeding mother
* Diagnosis of other significant chronic inflammatory or autoimmune disorders. Patients with the following autoimmune disorders are excluded from the study: Multiple sclerosis, primary biliary cirrhosis, type I diabetes mellitus. Patients with the following autoimmune disorders are regarded as eligible: Lichen sclerosus, vitiligo, alopecia arthritis, thyroid diseases (e.g. Hashimoto disease). Patients with any autoimmune disorder not listed above should only be included after consultation with the pri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
LoSCAT target lesion
Timeframe: Baseline to End of Treatment Visit, 24 weeks