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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bond Avillion 2 Development LP
Study ID
NCT03384745
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 31, 2018
Status verified
Aug 2021
Primary completion
Jun 20, 2019
Completion
Mar 26, 2020

Study Design

Enrollment
313 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: M1095 (Sonelokimab) 30mg
    M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
  • Experimental: M1095 (Sonelokimab) 60mg
    M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
  • Experimental: M1095 (Sonelokimab) 120mg - regimen 1
    M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.
  • Experimental: M1095 (Sonelokimab) 120mg - regimen 2
    M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.
  • 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.
  • Active Comparator: Secukinumab
    Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.

Primary Outcome Measure

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) ]

Locations (11)

FacilityCityStateZIPSite coordinators
Investigative SiteBirminghamAlabama35205-
Investigative SiteSan DiegoCalifornia92123-
Investigative SiteDeLandFlorida32720-
Investigative SiteSandy SpringsGeorgia30328-
Investigative SiteSt LouisMissouri63117-
Investigative SiteAlbuquerqueNew Mexico87102-
Investigative SiteNew YorkNew York10029-
Investigative SiteBexleyOhio43209-
Investigative SiteDallasTexas75246-
Investigative SiteHoustonTexas77004-
Investigative SiteSan AntonioTexas78229-

Find similar trials in Birmingham, AL

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Investigative Site· Birmingham, ALInvestigative Site· San Diego, CAInvestigative Site· DeLand, FLInvestigative Site· Sandy Springs, GAInvestigative Site· St Louis, MOInvestigative Site· Albuquerque, NM

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