Trials / Completed
CompletedNCT03384745
A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 313 (actual)
- Sponsor
- Bond Avillion 2 Development LP · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-07-31
- Primary completion
- 2019-06-20
- Completion
- 2020-03-26
- First posted
- 2017-12-27
- Last updated
- 2021-08-03
- Results posted
- 2021-08-02
Locations
60 sites across 7 countries: United States, Bulgaria, Canada, Czechia, Germany, Hungary, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03384745. Inclusion in this directory is not an endorsement.