A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis

• Status: Completed
• Trial end date: 2020-03-26
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites in North America and Europe.

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

Details

• Lead Sponsor: Bond Avillion 2 Development LP
• Collaborator: Avillion LLP

Criteria

Inclusion Criteria:

1. Male and female subjects between 18 and 75 years of age.

2. Moderate to severe plaque-type psoriasis for at least 6 months.

3. Subject is a candidate for systemic biologic therapy.

4. Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline.

5. Subject is able to comply with the study procedures.

6. Subject must provide informed consent.

Exclusion Criteria (Main):

1. Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed).

2. Other medical conditions, including planned surgery or active infection / history of infection, as defined in the study protocol. Subjects will be screened for tuberculosis and hepatitis B / hepatitis C.

3. Laboratory abnormalities at screening, as defined in the study protocol.

4. Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol.

5. Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.

6. History of suicidal thoughts within 12 months.