Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study investigates the efficacy and safety of dupilumab in the treatment of keloids

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

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Regeneron Pharmaceuticals

Criteria

Inclusion Criteria:

• Men and women between the ages of 18 and 65 at the time of dupilumab initiation.

• Subjects must have either one keloid with ≥ 2 cm length-wise or at least two keloids with ≥ 0.4 cm (width) x 0.4 cm (length)

• Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed.

Exclusion Criteria:

• History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis (Tb) infection as defined by a positive QuantiFERON TB-Gold test at screening.

• Known infection with HIV, hepatitis B or hepatitis C at screening.

• Are currently pregnant, breastfeeding, or planning to get pregnant during the study.

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 8 weeks after stopping treatment. Methods of acceptable birth control are listed below under "Women of Childbearing Potential"

• Previous hypersensitivity reaction to dupilumab.

• Patients with acute asthma, acute bronchospasm or status asthmaticus.

• Patients with known helminth infections.

• Currently on any other immunosuppressant systemic medication or within 28 days of baseline visit.

• Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.

• Are participating in another study using an investigational agent or procedure during participation in this study or within 28 days prior to baseline visit.

• Any other treatment for keloids with 28 days prior to baseline visit, including silicone gel/sheets, laser therapy, intralesional steroid or 5-fluorouracil injections, topical steroid, cryotherapy, surgery, or radiation therapy.

• Has had a live vaccine