Study to evaluate effectiveness and safety in subjects with moderate to severe Psoriasis

Phase 1

• Conditions: Moderate to Severe Psoriasis; MedDRA version: 19.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-002481-31-LV
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-28
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 516

Inclusion Criteria

- Male and female, ages 18 to 70 years
- Diagnosis of plaque psoriasis for less or equal to 6 months
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test, must not be pregnant, lactating, breastfeeding or planning pregnancy.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the study drug plus 90 days.
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 439
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 77

Exclusion Criteria

- Diagnosis of non-plaque psoriasis
- History or evidence of active infection and/or febrile illness
- Any significant acute or chronic medical illness
- Blood transfusion within 4 weeks of study drug administration
- Inability to tolerate oral medication
- Positive hepatitis-B (HBV) surface antigen
- Positive hepatitis-C (HCV) antibody
- Any history or risk for tuberculosis (TB)
- Any major illness/condition or evidence of an unstable clinical condition
- Chest X-ray findings suspicious of infection at screening
- Has received ustekinumab, secukinumab or ixikizumab within 6 months of first administration of study medication
- Has received anti-TNF inhibitor(s) within 2 months of first administration of study medication
- Has received Rituximab within 6 months of first administration of study medication
- Topical medications/treatments for psoriasis within 2 weeks of the first administration of any study medication
- any systemic medications/treatments for psoriasis within 4 weeks of the first administration of any study medication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified