MedTrace Logo

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

NCT03384745 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2021-08-03

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

M1095 (Sonelokimab)

M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.

DRUG

Placebo

Placebo contains no active drug.

DRUG

Secukinumab

Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.

Sponsors & Collaborators

  • Avillion LLP

    collaborator INDUSTRY

  • Bond Avillion 2 Development LP

    lead INDUSTRY

Principal Investigators

  • Dr. Kim Papp · Probity Medical Research Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2019-06-20
Completion
2020-03-26
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03384745 on ClinicalTrials.gov