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

Avillion

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: M1095 (Sonelokimab); Drug: Placebo; Drug: Secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03384745

AV002

Details and patient eligibility

About

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.

Enrollment: 313 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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313 participants in 6 patient groups, including a placebo group

M1095 (Sonelokimab) 30mg

Experimental group

Description:

M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

Treatment:

Drug: M1095 (Sonelokimab)

M1095 (Sonelokimab) 60mg

Experimental group

Description:

M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

Treatment:

Drug: M1095 (Sonelokimab)

M1095 (Sonelokimab) 120mg - regimen 1

Experimental group

Description:

M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.

Treatment:

Drug: M1095 (Sonelokimab)

M1095 (Sonelokimab) 120mg - regimen 2

Experimental group

Description:

M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.

Treatment:

Drug: M1095 (Sonelokimab)

Placebo / M1095 (Sonelokimab) 120mg

Placebo Comparator group

Description:

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.

Treatment:

Drug: M1095 (Sonelokimab)

Drug: Placebo

Secukinumab

Active Comparator group

Description:

Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.

Treatment:

Drug: Secukinumab