Clinical trial NCT03384745: A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis
Official title: A Phase 2b Randomized, Double-blind, Placebo Controlled, Multi-center 12-week Study With an Additional 40-week Follow-up Assessment of Efficacy, Safety and Tolerability of M1095 in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Bond Avillion 2 Development LP
Sponsor class: INDUSTRY
Collaborators: name: Avillion LLP
First posted: 2017-12-27
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

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.

Primary outcomes:
measure: Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1
timeFrame: Week 12, as compared to Week 0 (baseline)
Secondary outcomes:
measure: Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)
timeFrame: Week 12, as compared to Week 0 (baseline)
measure: Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)
timeFrame: Week 12, as compared to baseline
measure: Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)
timeFrame: Week 12, as compared to Week 0 (baseline)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigative Site
state: Alabama
city: San Diego
country: United States
facility: Investigative Site
state: California
city: DeLand
country: United States
facility: Investigative Site
state: Florida
city: Sandy Springs
country: United States
facility: Investigative Site
state: Georgia
city: Saint Louis
country: United States
facility: Investigative Site
state: Missouri
city: Albuquerque
country: United States
facility: Investigative Site
state: New Mexico
city: New York
country: United States
facility: Investigative Site
state: New York
city: Bexley
country: United States
facility: Investigative Site
state: Ohio
city: Dallas
country: United States
facility: Investigative Site
state: Texas
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Investigative Site
state: Texas
city: Dupnitsa
country: Bulgaria
facility: Investigative Site
city: Sofia
country: Bulgaria
facility: Investigative Site
city: Varna
country: Bulgaria
facility: Investigative Site
city: Edmonton
country: Canada
facility: Investigative Site
state: Alberta
city: Surrey
country: Canada
facility: Investigative Site
state: British Columbia
city: Surrey
country: Canada
facility: Investigative Site
state: British Columbia
city: Markham
country: Canada
facility: Investigative Site
state: Ontario
city: North Bay
country: Canada
facility: Investigative Site
state: Ontario
city: Oakville
country: Canada
facility: Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Investigative Site
state: Ontario
city: Richmond Hill
country: Canada
facility: Investigative Site
state: Ontario
city: Waterloo
country: Canada
facility: Investigative Site
state: Ontario
city: Windsor
country: Canada
facility: Investigative Site
state: Ontario
city: Quebec City
country: Canada
facility: Investigative Site
state: Quebec
city: Brno
country: Czechia
facility: Investigative Site
city: Nový Jičín
country: Czechia
facility: Investigative Site
city: Náchod
country: Czechia
facility: Investigative Site
city: Ostrava
country: Czechia
facility: Investigative Site
city: Ostrava
country: Czechia
facility: Investigative Site
city: Pardubice
country: Czechia
facility: Investigative Site
city: Praha
country: Czechia
facility: Investigative Site
city: Uherské Hradiště
country: Czechia
facility: Investigative Site
city: Augsburg
country: Germany
facility: Investigative Site
city: Berlin
country: Germany
facility: Investigative Site
city: Bochum
country: Germany
facility: Investigative Site
city: Darmstadt
country: Germany
facility: Investigative Site
city: Frankfurt/Main
country: Germany
facility: Investigative Site
city: Friedrichshafen
country: Germany
facility: Investigative Site
city: Hamburg
country: Germany
facility: Investigative Site
city: Kiel
country: Germany
facility: Investigative Site
city: Mahlow
country: Germany
facility: Investigative Site
city: Mainz
country: Germany
facility: Investigative Site
city: Osnabrück
country: Germany
facility: Investigative Site
city: Quedlinburg
country: Germany
facility: Investigative Site
city: Schwerin
country: Germany
facility: Investigative Site
city: Budapest
country: Hungary
facility: Investigative Site
city: Budapest
country: Hungary
facility: Investigative Site
city: Kecskemét
country: Hungary
facility: Investigative Site
city: Orosháza
country: Hungary
facility: Investigative Site
city: Szeged
country: Hungary
facility: Investigative Site
city: Szolnok
country: Hungary
facility: Investigative Site
city: Katowice
country: Poland
facility: Investigative Site
city: Lublin
country: Poland
facility: Investigative Site
city: Poznań
country: Poland
facility: Investigative Site
city: Siedlce
country: Poland
facility: Investigative Site
city: Skierniewice
country: Poland
facility: Investigative Site
city: Warszawa
country: Poland
facility: Investigative Site
city: Warszawa
country: Poland
facility: Investigative Site
city: Warszawa
country: Poland
facility: Investigative Site
Study officials:
affiliation: Probity Medical Research Inc
name: Dr. Kim Papp
role: PRINCIPAL_INVESTIGATOR
References:
citation: Papp KA, Weinberg MA, Morris A, Reich K. IL17A/F nanobody sonelokimab in patients with plaque psoriasis: a multicentre, randomised, placebo-controlled, phase 2b study. Lancet. 2021 Apr 24;397(10284):1564-1575. doi: 10.1016/S0140-6736(21)00440-2.