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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384745
• Other study ID #: AV002
• Status: Completed
• Phase: Phase 2
• Start date: July 31, 2018
• Est. completion date: March 26, 2020

Study information

• Verified date: August 2021
• Source: Bond Avillion 2 Development LP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: March 26, 2020
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• M1095 (Sonelokimab)
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
• Placebo
Placebo contains no active drug.
• Secukinumab
Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.

Locations

Country	Name	City	State
Bulgaria	Investigative Site	Dupnitsa
Bulgaria	Investigative Site	Sofia
Bulgaria	Investigative Site	Varna
Canada	Investigative Site	Edmonton	Alberta
Canada	Investigative Site	Markham	Ontario
Canada	Investigative Site	North Bay	Ontario
Canada	Investigative Site	Oakville	Ontario
Canada	Investigative Site	Ottawa	Ontario
Canada	Investigative Site	Quebec City	Quebec
Canada	Investigative Site	Richmond Hill	Ontario
Canada	Investigative Site	Surrey	British Columbia
Canada	Investigative Site	Surrey	British Columbia
Canada	Investigative Site	Waterloo	Ontario
Canada	Investigative Site	Windsor	Ontario
Czechia	Investigative Site	Brno
Czechia	Investigative Site	Náchod
Czechia	Investigative Site	Nový Jicín
Czechia	Investigative Site	Ostrava
Czechia	Investigative Site	Ostrava
Czechia	Investigative Site	Pardubice
Czechia	Investigative Site	Praha
Czechia	Investigative Site	Uherské Hradište
Germany	Investigative Site	Augsburg
Germany	Investigative Site	Berlin
Germany	Investigative Site	Bochum
Germany	Investigative Site	Darmstadt
Germany	Investigative Site	Frankfurt/Main
Germany	Investigative Site	Friedrichshafen
Germany	Investigative Site	Hamburg
Germany	Investigative Site	Kiel
Germany	Investigative Site	Mahlow
Germany	Investigative Site	Mainz
Germany	Investigative Site	Osnabrück
Germany	Investigative Site	Quedlinburg
Germany	Investigative Site	Schwerin
Hungary	Investigative Site	Budapest
Hungary	Investigative Site	Budapest
Hungary	Investigative Site	Kecskemét
Hungary	Investigative Site	Orosháza
Hungary	Investigative Site	Szeged
Hungary	Investigative Site	Szolnok
Poland	Investigative Site	Katowice
Poland	Investigative Site	Lublin
Poland	Investigative Site	Poznan
Poland	Investigative Site	Siedlce
Poland	Investigative Site	Skierniewice
Poland	Investigative Site	Warszawa
Poland	Investigative Site	Warszawa
Poland	Investigative Site	Warszawa
United States	Investigative Site	Albuquerque	New Mexico
United States	Investigative Site	Bexley	Ohio
United States	Investigative Site	Birmingham	Alabama
United States	Investigative Site	Dallas	Texas
United States	Investigative Site	DeLand	Florida
United States	Investigative Site	Houston	Texas
United States	Investigative Site	New York	New York
United States	Investigative Site	Saint Louis	Missouri
United States	Investigative Site	San Antonio	Texas
United States	Investigative Site	San Diego	California
United States	Investigative Site	Sandy Springs	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Bond Avillion 2 Development LP	Avillion LLP

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  Germany,  Hungary,  Poland, 

References & Publications (1)

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. Erratum i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1	The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.	Week 12, as compared to Week 0 (baseline)
Secondary	Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)	PASI 100, i.e. a subject's psoriasis has completely cleared at Week 12, compared to baseline.	Week 12, as compared to Week 0 (baseline)
Secondary	Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)	PASI 90, i.e. a subject's psoriasis has cleared by 90% at Week 12, compared to baseline	Week 12, as compared to baseline
Secondary	Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)	PASI 75, i.e. a subject's psoriasis has cleared by 75% at Week 12, compared to baseline	Week 12, as compared to Week 0 (baseline)