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.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

efficacy of sarilumab in plaque type morphea

Timeframe: Week 24

NCT IDNCT03679845

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-30

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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