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Completed

NCT Number: NCT02931838

Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis

A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Kogarah, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Male and female, ages 18 to 70 years
  • Diagnosis of plaque psoriasis for 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.

Exclusion criteria

  • 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 ixekizumab within 6 months of first administration of study medication
  • Has received anti-Tumor Necrosis Factor (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

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

BMS-986165

Drug

Placebo for BMS-986165

Drug

Primary outcomes

  1. The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12)

    Time frame: Day 1 to Day 85

    Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.

  2. Number of Participants With Adverse Events

    Time frame: Day 1 to day 115

    The safety and tolerability of BMS-986195 as assessed by the number of subjects with adverse events (AEs); number of subjects with serious adverse events (SAEs); number of subjects with adverse events leading to discontinuation

Secondary outcomes

  1. Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100.

    Time frame: Day 1 to Day 85

    Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 90 and PASI 100 responses on Day 85. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders. PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders. PASI 100 response: patients who achieved ≥ 100% improvement (reduction) in PASI score compared to baseline were defined as PASI 100 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.

  2. Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate).

    Time frame: Day 1 to Day 85

    Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) on Day 85. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.

  3. Change From Baseline in DLQI Scores on Day 85

    Time frame: Day 1 to Day 85

    The DLQI is a participant reported quality of life index which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 by a tick box: "not at all", "a little", "a lot", or "very much". The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment)

  4. Change From Baseline in BSA on Day 85

    Time frame: Day 1 to Day 85

    Measurement of psoriasis body surface area (BSA) involvement is estimated using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.The total BSA = 100% with breakdown by body region as follows: head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), trunk including axillae and groin = 30% (30 handprints), lower extremities including buttocks = 40% (40 handprints). A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Day 85 score; a positive change from Baseline therefore indicates improvement.

  5. Trough Observed Plasma Concentration of BMS-986165 (Ctrough)

    Time frame: Days 8, 15, 29, 57, 85

    Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986165 in Subjects With Moderate to Severe Psoriasis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 13, 2016
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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