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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
313

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bond Avillion 2 Development LP

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Avillion LLP

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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