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

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ClinicalTrials.gov Identifier: NCT03384745
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
Avillion LLP
Information provided by (Responsible Party):
Bond Avillion 2 Development LP

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: M1095 Drug: Placebo Drug: Secukinumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: M1095 30mg
M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
Drug: M1095
M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.

Experimental: M1095 60mg
M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
Drug: M1095
M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.

Experimental: M1095 120mg - regimen 1
M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.
Drug: M1095
M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.

Experimental: M1095 120mg - regimen 2
M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.
Drug: M1095
M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.

Placebo Comparator: Placebo / M1095 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
M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.

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 Name: Cosentyx®




Primary Outcome Measures :
  1. Investigator's Global Assessment (IGA) [ Time Frame: Week 12, as compared to Week 0 (baseline) ]
    IGA score of 0 or 1, with an IGA reduction of at least 2 points from baseline. IGA is the Investigator's 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).


Secondary Outcome Measures :
  1. Psoriasis Area and Severity Index (PASI) [ Time Frame: Week 12, as compared to Week 0 (baseline) ]
    PASI 75, i.e. a subject's psoriasis has cleared by 75% or more at Week 12, compared to baseline.

  2. Psoriasis Area and Severity Index (PASI) [ 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384745


Contacts
Contact: Dr. Mark Weinberg, MD +44 (0)203 764 9530 mark@avillionllp.com
Contact: Alun Morris +44 (0)203 764 9536 alun@avillionllp.com

  Show 60 Study Locations
Sponsors and Collaborators
Bond Avillion 2 Development LP
Avillion LLP
Investigators
Principal Investigator: Dr. Kim Papp Probity Medical Research Inc

Responsible Party: Bond Avillion 2 Development LP
ClinicalTrials.gov Identifier: NCT03384745     History of Changes
Other Study ID Numbers: AV002
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs