Study to Assess Sarilumab in Halting Progression of Morphea

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Morphea, Plaque Form

In brief

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

Key facts

Study ID

NCT03679845

Run by

Massachusetts General Hospital

People needed

0

Starts

2019-09-01

Expected to finish

2021-06-30

Last updated by the study team

2021-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Cancer within 5 years other than non-melanoma skin cancer or cervical cancer in situ that has been fully treated.
• Known hypersensitivity to any of the constituents or excipients of the investigational product
• Use of any prescription or non-prescription medication that could interfere with efficacy evaluations in the study
• Participation in another clinical research study with an investigational drug within 4 weeks before this study

Where it is running

• CURTIS (Massachusetts General Hospital) — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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