Study to Assess Sarilumab in Halting Progression of Morphea

• Status: Withdrawn
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Regeneron Pharmaceuticals

Criteria

Inclusion Criteria:

1. Male or female subject 18 years of age or older

2. Only circumscribed (plaque) morphea with at least one active morphea target lesion (0.5-10 cm2), with mLoSSI ≥ 5.

3. Body surface area affected by morphea lesions: ≤ 50% at start of treatment

4. 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.

5. Willingness of subject to follow all study procedures

6. Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight

Exclusion Criteria:

1. Use any topical medication treating morphea within 14 days prior to Day 1

2. Pregnancy or breast feeding

3. 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

4. Cancer within 5 years other than non-melanoma skin cancer or cervical cancer in situ that has been fully treated.

5. Known hypersensitivity to any of the constituents or excipients of the investigational product

6. Use of any prescription or non-prescription medication that could interfere with efficacy evaluations in the study

7. Participation in another clinical research study with an investigational drug within 4 weeks before this study