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

August 2, 2021 updated by: Bond Avillion 2 Development LP

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

313

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Dupnitsa, Bulgaria, 2600
        • Investigative Site
      • Sofia, Bulgaria, 1431
        • Investigative Site
      • Varna, Bulgaria, 9010
        • Investigative Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5K 1X3
        • Investigative Site
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Investigative Site
      • Surrey, British Columbia, Canada, V3V 0C6
        • Investigative Site
    • Ontario
      • Markham, Ontario, Canada, L3P 1X2
        • Investigative Site
      • North Bay, Ontario, Canada, P1B 3Z7
        • Investigative Site
      • Oakville, Ontario, Canada, L6J 7W5
        • Investigative Site
      • Ottawa, Ontario, Canada, K2G 6E2
        • Investigative Site
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • Investigative Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Investigative Site
      • Windsor, Ontario, Canada, N8W 1E6
        • Investigative Site
    • Quebec
      • Quebec City, Quebec, Canada, G1V 4X7
        • Investigative Site
  • Czechia
      • Brno, Czechia, 602 00
        • Investigative Site
      • Nový Jičín, Czechia, 741 01
        • Investigative Site
      • Náchod, Czechia, 547 01
        • Investigative Site
      • Ostrava, Czechia, 702 00
        • Investigative Site
      • Ostrava, Czechia, 708 52
        • Investigative Site
      • Pardubice, Czechia, 530 02
        • Investigative Site
      • Praha, Czechia, 130 00
        • Investigative Site
      • Uherské Hradiště, Czechia, 686 01
        • Investigative Site
  • Germany
      • Augsburg, Germany, 86179
        • Investigative Site
      • Berlin, Germany, 10789
        • Investigative Site
      • Bochum, Germany, 44793
        • Investigative Site
      • Darmstadt, Germany, 64297
        • Investigative Site
      • Frankfurt/Main, Germany, 60590
        • Investigative Site
      • Friedrichshafen, Germany, 88045
        • Investigative Site
      • Hamburg, Germany, 20354
        • Investigative Site
      • Kiel, Germany, 24105
        • Investigative Site
      • Mahlow, Germany, 15831
        • Investigative Site
      • Mainz, Germany, 55131
        • Investigative Site
      • Osnabrück, Germany, 49074
        • Investigative Site
      • Quedlinburg, Germany, 06484
        • Investigative Site
      • Schwerin, Germany, 19055
        • Investigative Site
  • Hungary
      • Budapest, Hungary, 1085
        • Investigative Site
      • Budapest, Hungary, 1135
        • Investigative Site
      • Kecskemét, Hungary, 6000
        • Investigative Site
      • Orosháza, Hungary, 5900
        • Investigative Site
      • Szeged, Hungary, 6720
        • Investigative Site
      • Szolnok, Hungary, 5000
        • Investigative Site
  • Poland
      • Katowice, Poland, 40-060
        • Investigative Site
      • Lublin, Poland, 20-314
        • Investigative Site
      • Poznań, Poland, 60-848
        • Investigative Site
      • Siedlce, Poland, 08-110
        • Investigative Site
      • Skierniewice, Poland, 96-100
        • Investigative Site
      • Warszawa, Poland, 02-507
        • Investigative Site
      • Warszawa, Poland, 02-777
        • Investigative Site
      • Warszawa, Poland, 04-141
        • Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Investigative Site
    • California
      • San Diego, California, United States, 92123
        • Investigative Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Investigative Site
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Investigative Site
    • New York
      • New York, New York, United States, 10029
        • Investigative Site
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Investigative Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Investigative Site
      • Houston, Texas, United States, 77004
        • Investigative Site
      • San Antonio, Texas, United States, 78229
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: M1095 (Sonelokimab) 30mg
M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
Drug: M1095 (Sonelokimab)
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
Other Names:
  • Sonelokimab
Experimental: M1095 (Sonelokimab) 60mg
M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
Drug: M1095 (Sonelokimab)
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
Other Names:
  • Sonelokimab
Experimental: M1095 (Sonelokimab) 120mg - regimen 1
M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.
Drug: M1095 (Sonelokimab)
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
Other Names:
  • Sonelokimab
Experimental: M1095 (Sonelokimab) 120mg - regimen 2
M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.
Drug: M1095 (Sonelokimab)
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
Other Names:
  • Sonelokimab
Placebo Comparator: Placebo / M1095 (Sonelokimab) 120mg
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)
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
Other Names:
  • Sonelokimab
Drug: Placebo
Placebo contains no active drug.
Active Comparator: Secukinumab
Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.
Drug: Secukinumab
Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
Other Names:
  • Cosentyx®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1
Time Frame: Week 12, as compared to Week 0 (baseline)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)
Time Frame: Week 12, as compared to Week 0 (baseline)
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)
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)
Time Frame: Week 12, as compared to baseline
PASI 90, i.e. a subject's psoriasis has cleared by 90% at Week 12, compared to baseline
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)
Time Frame: Week 12, as compared to Week 0 (baseline)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bond Avillion 2 Development LP

Collaborators

Avillion LLP

Investigators

  • Principal Investigator: Dr. Kim Papp, Probity Medical Research Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2018

Primary Completion (Actual)

June 20, 2019

Study Completion (Actual)

March 26, 2020

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 27, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AV002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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