Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

Bond Avillion 2 Development LP

Collaborating Sponsors:

Avillion LLP

Conditions:

Psoriasis

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

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 Ame...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria (Main):
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    July 31 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 26 2020

    Estimated Enrollment :

    313 Patients enrolled

    Trial Details

    Trial ID

    NCT03384745

    Start Date

    July 31 2018

    End Date

    March 26 2020

    Last Update

    August 3 2021

    Active Locations (60)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 15 (60 locations)

    1

    Investigative Site

    Birmingham, Alabama, United States, 35205

    2

    Investigative Site

    San Diego, California, United States, 92123

    3

    Investigative Site

    DeLand, Florida, United States, 32720

    4

    Investigative Site

    Sandy Springs, Georgia, United States, 30328