Safety and efficacy and tolerability of M1095 in subjects with moderate to severe, chronic plaque-type psoriasis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. Ambulatory male and female subjects between 18 and 75 years of age at time of consent.
2. Subject has had stable moderate to severe plaque-type psoriasis for at least 6 months prior to randomization (e.g. no morphology changes or significant flares of disease activity in the opinion of the investigator).
3. Subject must be considered, in the opinion of the investigator, not adequately controlled by photo, topical or previous systemic treatments and 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 in the opinion of the investigator able to comply with the study procedures.
6. Following verbal and written information about the study, subject must provide signed and dated informed consent before any study related activity is carried out.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Subject diagnosed with erythrodermic psoriasis, pustular psoriasis,
guttate psoriasis, or other skin conditions at the time of the screening
visit (e.g. eczema) that would interfere with evaluations of psoriasis
(Note: psoriatic arthritis is NOT exclusionary.)
2. Subject has drug-induced psoriasis.
3. Other medical conditions:
a. At the time of consent, subject has a planned in-patient surgical
intervention between baseline and the Week 52 evaluation.
b. Subject has an active infection or history of infections as follows:
i. Any active infection for which systemic anti-infectives were used
within 28 days prior to randomization.
ii. A serious infection, defined as requiring hospitalization or intravenous
anti-infectives within 8 weeks prior to randomization.
iii. Any history of bone infection requiring surgical intervention and/or
intravenous antibiotics.
iv. Recurrent or chronic infections or other active infection that, in the
opinion of the investigator, might cause this study to be detrimental to
the subject.
c. Subject has active tuberculosis.
d. Subject has a positive QuantiFERON®-TB Gold test for tuberculosis at
screening, or the first test and a repeat test are both indeterminate,
unless
(i) subject has a known history of latent TB and has completed a course
of treatment or
(ii) subject has received sufficient treatment for latent TB to allow
concomitant treatment with a biological therapy as per local guidelines
(note these subjects must continue their concomitant latent TB
treatment to completion while participating in the study). If these
subjects are outside of the screening window (>28 days since consent)
when they become eligible to participate, they should be fully rescreened
for the study.
e. Subject has an underlying condition (including, but not limited to
metabolic, hematologic, renal, hepatic, pulmonary, neurologic,
endocrine, cardiac, infectious or gastrointestinal) which in the opinion of
the investigator places the subject at unacceptable risk for receiving an
immunomodulatory therapy.
f. Subject has known history of inflammatory bowel disease.
g. Subject with known chronic liver disease or tests positive for hepatitis
B virus (HBV) infection or has antibodies to hepatitis C virus (HCV) at
screening.
h. Subject has antibodies to human immunodeficiency virus (HIV) at
screening.
i. Subject has history of heart failure, myocardial infarction or unstable
angina pectoris within the past 12 months prior to randomization.
j. Subject has uncontrolled hypertension characterized by two blood
pressure measurements separated by at least 15 minutes with systolic
>160mmHg or diastolic >100mmHg.
k. Subject has clinically significant electrocardiogram (ECG)
abnormalities on centrally read ECG.
l. Subject has any active malignancy, including evidence of cutaneous
basal or squamous cell carcinoma or melanoma.
m. Subject has history of malignancy within 5 years EXCEPT cutaneous
squamous or basal cell carcinoma, in situ cervical cancer, or in situ
breast ductal carcinoma which has been treated and considered cured.
n. Subject has any concurrent medical condition that, in the opinion of
the investigator, could cause this study to be detrimental to the subject.
4. Subject has laboratory abnormalities at screening, including any of
the following:
a. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
>2 x the upper limit of normal (one retest is allowed for
am

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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