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

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: M1095 (Sonelokimab); Drug: Secukinumab; Drug: Placebo

• Registration Number: NCT03384745
• Lead Sponsor: Bond Avillion 2 Development LP

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 America and Europe.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-27
• Study Start: 2018-07-31
• Primary Completion: 2019-06-20
• Study Completion: 2020-03-26
• Results First Submitted: 2021-04-01
• Results First Submitted QC: 2021-07-09
• Status Verified: 2021-08
• Results First Posted: 2021-08-02
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

1. Male and female subjects between 18 and 75 years of age.
2. Moderate to severe plaque-type psoriasis for at least 6 months.
3. Subject is a candidate for systemic biologic therapy.
4. Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline.
5. Subject is able to comply with the study procedures.
6. Subject must provide informed consent.

Exclusion Criteria (Main):

1. Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed).
2. 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.
3. Laboratory abnormalities at screening, as defined in the study protocol.
4. Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol.
5. Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.
6. History of suicidal thoughts within 12 months.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M1095 (Sonelokimab) 60mg	M1095 (Sonelokimab)	M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
M1095 (Sonelokimab) 120mg - regimen 2	M1095 (Sonelokimab)	M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.
Placebo / M1095 (Sonelokimab) 120mg	M1095 (Sonelokimab)	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.
M1095 (Sonelokimab) 30mg	M1095 (Sonelokimab)	M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
M1095 (Sonelokimab) 120mg - regimen 1	M1095 (Sonelokimab)	M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.
Placebo / M1095 (Sonelokimab) 120mg	Placebo	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.
Secukinumab	Secukinumab	Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1	Week 12, as compared to Week 0 (baseline)	The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)	Week 12, as compared to Week 0 (baseline)	PASI 100, i.e. a subject's psoriasis has completely cleared at Week 12, compared to baseline.
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)	Week 12, as compared to Week 0 (baseline)	PASI 75, i.e. a subject's psoriasis has cleared by 75% at Week 12, compared to baseline
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)	Week 12, as compared to baseline	PASI 90, i.e. a subject's psoriasis has cleared by 90% at Week 12, compared to baseline

Trial Locations

Locations (1)

Investigative Site; 🇵🇱 Warszawa, Poland