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

NCT03384745 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AV002
• Study Type: interventional
• Target: 313
• Locations: 7 countries
• Sites: 60

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)

  Week 12, as compared to Week 0 (baseline)

• Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)

  Week 12, as compared to baseline

• Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)

  Week 12, as compared to Week 0 (baseline)

Study Arms (6)

M1095 (Sonelokimab) 30mg

EXPERIMENTAL

M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

Drug: M1095 (Sonelokimab)

M1095 (Sonelokimab) 60mg

EXPERIMENTAL

M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

Drug: M1095 (Sonelokimab)

M1095 (Sonelokimab) 120mg - regimen 1

EXPERIMENTAL

M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.

Drug: M1095 (Sonelokimab)

M1095 (Sonelokimab) 120mg - regimen 2

EXPERIMENTAL

M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.

Drug: M1095 (Sonelokimab)

Placebo / M1095 (Sonelokimab) 120mg

PLACEBO COMPARATOR

Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks.

Drug: M1095 (Sonelokimab); Drug: Placebo

Secukinumab

ACTIVE COMPARATOR

Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.

Drug: Secukinumab

Interventions

M1095 (Sonelokimab) DRUG

M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.

Also known as: Sonelokimab

M1095 (Sonelokimab) 120mg - regimen 1; M1095 (Sonelokimab) 120mg - regimen 2; M1095 (Sonelokimab) 30mg; M1095 (Sonelokimab) 60mg; Placebo / M1095 (Sonelokimab) 120mg

Placebo DRUG

Placebo contains no active drug.

Placebo / M1095 (Sonelokimab) 120mg

Secukinumab DRUG

Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.

Also known as: Cosentyx®

Secukinumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bond Avillion 2 Development LP: lead
• Avillion LLP: collaborator

Study Sites (60)

Investigative Site

Birmingham, Alabama, 35205, United States

Location

Investigative Site

San Diego, California, 92123, United States

Location

Investigative Site

DeLand, Florida, 32720, United States

Location

Investigative Site

Sandy Springs, Georgia, 30328, United States

Location

Investigative Site

St Louis, Missouri, 63117, United States

Location

Investigative Site

Albuquerque, New Mexico, 87102, United States

Location

Investigative Site

New York, New York, 10029, United States

Location

Investigative Site

Bexley, Ohio, 43209, United States

Location

Investigative Site

Dallas, Texas, 75246, United States

Location

Investigative Site

Houston, Texas, 77004, United States

Location

Investigative Site

San Antonio, Texas, 78229, United States

Location

Investigative Site

Dupnitsa, 2600, Bulgaria

Location

Investigative Site

Sofia, 1431, Bulgaria

Location

Investigative Site

Varna, 9010, Bulgaria

Location

Investigative Site

Edmonton, Alberta, T5K 1X3, Canada

Location

Investigative Site

Surrey, British Columbia, V3R 6A7, Canada

Location

Investigative Site

Surrey, British Columbia, V3V 0C6, Canada

Location

Investigative Site

Markham, Ontario, L3P 1X2, Canada

Location

Investigative Site

North Bay, Ontario, P1B 3Z7, Canada

Location

Investigative Site

Oakville, Ontario, L6J 7W5, Canada

Location

Investigative Site

Ottawa, Ontario, K2G 6E2, Canada

Location

Investigative Site

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Investigative Site

Waterloo, Ontario, N2J 1C4, Canada

Location

Investigative Site

Windsor, Ontario, N8W 1E6, Canada

Location

Investigative Site

Québec, Quebec, G1V 4X7, Canada

Location

Investigative Site

Brno, 602 00, Czechia

Location

Investigative Site

Náchod, 547 01, Czechia

Location

Investigative Site

Nový Jičín, 741 01, Czechia

Location

Investigative Site

Ostrava, 702 00, Czechia

Location

Investigative Site

Ostrava, 708 52, Czechia

Location

Investigative Site

Pardubice, 530 02, Czechia

Location

Investigative Site

Prague, 130 00, Czechia

Location

Investigative Site

Uherské Hradiště, 686 01, Czechia

Location

Investigative Site

Augsburg, 86179, Germany

Location

Investigative Site

Berlin, 10789, Germany

Location

Investigative Site

Bochum, 44793, Germany

Location

Investigative Site

Darmstadt, 64297, Germany

Location

Investigative Site

Frankfurt am Main, 60590, Germany

Location

Investigative Site

Friedrichshafen, 88045, Germany

Location

Investigative Site

Hamburg, 20354, Germany

Location

Investigative Site

Kiel, 24105, Germany

Location

Investigative Site

Mahlow, 15831, Germany

Location

Investigative Site

Mainz, 55131, Germany

Location

Investigative Site

Osnabrück, 49074, Germany

Location

Investigative Site

Quedlinburg, 06484, Germany

Location

Investigative Site

Schwerin, 19055, Germany

Location

Investigative Site

Budapest, 1085, Hungary

Location

Investigative Site

Budapest, 1135, Hungary

Location

Investigative Site

Kecskemét, 6000, Hungary

Location

Investigative Site

Orosháza, 5900, Hungary

Location

Investigative Site

Szeged, 6720, Hungary

Location

Investigative Site

Szolnok, 5000, Hungary

Location

Investigative Site

Katowice, 40-060, Poland

Location

Investigative Site

Lublin, 20-314, Poland

Location

Investigative Site

Poznan, 60-848, Poland

Location

Investigative Site

Siedlce, 08-110, Poland

Location

Investigative Site

Skierniewice, 96-100, Poland

Location

Investigative Site

Warsaw, 02-507, Poland

Location

Investigative Site

Warsaw, 02-777, Poland

Location

Investigative Site

Warsaw, 04-141, Poland

Location

Related 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.

  PMID: 33894834 RESULT

MeSH Terms

Conditions

Psoriasis

Interventions

sonelokimab; secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Avillion LLP

avillion@avillionllp.com

+44 (0)203 764 9530

Study Officials

• Dr. Kim Papp

  Probity Medical Research Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 27, 2017
• Study Start: July 31, 2018
• Primary Completion: June 20, 2019
• Study Completion: March 26, 2020
• Last Updated: August 3, 2021
• Results First Posted: August 2, 2021

Record last verified: 2021-08

Locations

PL (8); CA (11); DE (13); HU (6); CZ (8); BU (3); US (11)