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

Phase 2 Completed 313 enrolled Bond Avillion 2 Development LP Avillion LLP · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2018-07-31
Primary completion: 2019-06-20
Completion: 2020-03-26

Outcome

Met primary endpoint

registry analysis (superiority test); M1095 30mg vs Placebo; p <0.0001; Cochran-Mantel-Haenszel NCT03384745 ↗

registry analysis (superiority test); M1095 60mg vs Placebo; p <0.0001; Cochran-Mantel-Haenszel NCT03384745 ↗

paper At week 12, none (0·0% [95% CI 0·0-6·8]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 25 PMID 33894834 ↗

paper 44 (84·6% [71·9-93·1], p<0·0001) of 52 participants in the sonelokimab 60 mg group PMID 33894834 ↗

Publications

Results Papp KA, Weinberg MA, Morris A, Reich K. IL17A/F nanobody sonelokimab in patients with plaque psoriasis: a multicentre, randomised, placebo-controlled, phase 2b study. Lancet. 2021 Apr 24;397(10284):1564-1575. doi: 10.1016/S0140-6736(21)00440-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	M1095	Protein / enzyme biologic	30 mg	Subcutaneous
Subject	M1095	Protein / enzyme biologic	60 mg	Subcutaneous
Subject	M1095	Protein / enzyme biologic	120 mg	Subcutaneous
Comparator	Secukinumab	Monoclonal antibody	300 mg	Subcutaneous