CompletedPhase 2

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

United States313 participantsStarted 2018-07-31

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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

✕. 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.

What they're measuring

Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1

Timeframe: Week 12, as compared to Week 0 (baseline)

Trial details

NCT IDNCT03384745

SponsorBond Avillion 2 Development LP

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-20

Results submitted2021-04-01

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