Phase 2
N=313
A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT03384745 ↗Enrolled (actual)
313
Serious AEs
3.0%
Results posted
Aug 2021
Primary outcome: Primary: Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 — 25; 44; 41; 45 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- M1095 (Sonelokimab) (Drug); Placebo (Drug); Secukinumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bond Avillion 2 Development LP
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 |
25; 44; 41; 45; 0; 41 | <0.0001 sig |
| SECONDARY Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis) |
9; 13; 20; 17; 0; 15 | — |
| SECONDARY Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis) |
19; 34; 37; 39; 0; 34 | — |
| SECONDARY Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis) |
34; 46; 45; 46; 0; 48 | — |
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.
Eligibility Criteria
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 (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.
Data sourced from ClinicalTrials.gov (NCT03384745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.