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



Status:Recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:11/7/2018
Start Date:July 31, 2018
End Date:August 1, 2020
Contact:Dr. Mark Weinberg, MD
Email:mark@avillionllp.com
Phone:+44 (0)203 764 9530

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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

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.


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.
We found this trial at
12
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