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

Completed · Phase 2 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT03384745

Run by

Bond Avillion 2 Development LP

People needed

313

Starts

2018-07-31

Expected to finish

2020-03-26

Last updated by the study team

2021-08-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects between 18 and 75 years of age.
• Moderate to severe plaque-type psoriasis for at least 6 months.
• Subject is a candidate for systemic biologic therapy.
• Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline.
• Subject is able to comply with the study procedures.
• Subject must provide informed consent.
• Exclusion Criteria (Main):
• Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed).
• 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.
• Laboratory abnormalities at screening, as defined in the study protocol.
• Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol.
• Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.
• History of suicidal thoughts within 12 months.

Where it is running

• Investigative Site — San Diego, California, United States
• Investigative Site — DeLand, Florida, United States
• Investigative Site — Sandy Springs, Georgia, United States
• Investigative Site — St Louis, Missouri, United States
• Investigative Site — Albuquerque, New Mexico, United States
• Investigative Site — New York, New York, United States
• Investigative Site — Bexley, Ohio, United States
• Investigative Site — Dallas, Texas, United States
• Investigative Site — Houston, Texas, United States
• Investigative Site — San Antonio, Texas, United States
• Investigative Site — Dupnitsa, Bulgaria
• Investigative Site — Sofia, Bulgaria
• Investigative Site — Varna, Bulgaria
• Investigative Site — Edmonton, Alberta, Canada
• Investigative Site — Surrey, British Columbia, Canada
• Investigative Site — Surrey, British Columbia, Canada
• Investigative Site — Markham, Ontario, Canada
• Investigative Site — North Bay, Ontario, Canada
• Investigative Site — Oakville, Ontario, Canada
• Investigative Site — Ottawa, Ontario, Canada
• Investigative Site — Richmond Hill, Ontario, Canada
• Investigative Site — Waterloo, Ontario, Canada
• Investigative Site — Windsor, Ontario, Canada
• Investigative Site — Québec, Quebec, Canada
• Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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