WithdrawnPhase 1/2

Study to Assess Sarilumab in Halting Progression of Morphea

Stopped: Difficulty in recruiting patients

United States0Started 2019-09-01

Plain-language summary

An open-label single center trial studying the efficacy and safety of sarilumab on morphea patients.

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

. Male or female subject 18 years of age or older
. Only circumscribed (plaque) morphea with at least one active morphea target lesion (0.5-10 cm2), with mLoSSI ≥ 5.
. Body surface area affected by morphea lesions: ≤ 50% at start of treatment
. If subject has received any morphea treatment, subject must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 8 weeks prior to Day 1. Subject must be willing to stay on a stable regimen during the duration of the study.
. Willingness of subject to follow all study procedures
. Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight

Exclusion criteria

. Use any topical medication treating morphea within 14 days prior to Day 1
. Pregnancy or breast feeding
. Any condition (e.g. HIV, diabetes, ANC(absolute neutrophil count) \< 2,000/mm3, platelets \< 150,000/mm3 or AST(aspartate transaminase)/ALT(alanine aminotransferase) \> 1.5 times normal limits) or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study

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

efficacy of sarilumab in plaque type morphea

Timeframe: Week 24

Trial details

NCT IDNCT03679845

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Morphea, Plaque Form trials