NCT03384745.

Study name	A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 in Subjects With Moderate to Severe Psoriasis
Methods	RCT, active/placebo‐controlled, double‐blind study Date of study: July 2018 Location: worldwide Phase 2b
Participants	Randomised: 300 participants 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.
Interventions	Intervention A. M1095, 30 mg, given at week 0, 2, 4, 8, 12 and every four weeks. Control interventions B. M1095, 60 mg, given at week 0, 2, 4, 8, 12 and every four weeks. C. M1095, 120 mg, given at week 0, 2, 4, 8, 12 and every eight weeks. D. M1095, 120 mg, given at week 0, 2, 4, 8, 12 and every four weeks. E. Placebo
Outcomes	At week 12 Primary outcome IGA 0/1 Secondary outcomes PASI 75 PASI 100
Starting date	Study start date: July 2018 Estimated Study completion date: August 2020 Last Update Posted: January 2020, active, not recruiting
Contact information	Principal investigator: Dr Kim Papp Contact: Dr Mark Weinberg +44 (0)203 764 9530 mark@avillionllp.com
Notes	Sponsor: Bond Avillion 2 Development LP Ongoing study Last checked in September 2020