Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02931838
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02931838
Recruitment Status : Completed
First Posted : October 13, 2016
Results First Posted : November 27, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: BMS-986165 Drug: Placebo for BMS-986165 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : November 16, 2017
Actual Study Completion Date : November 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: BMS-986165 Dose 1
Specified dose of BMS-986165 on specified days.
Drug: BMS-986165
Experimental: BMS-986165 Dose 2
Specified dose of BMS-986165 on specified days.
Drug: BMS-986165
Experimental: BMS-986165 Dose 3
Specified dose of BMS-986165 on specified days.
Drug: BMS-986165
Experimental: BMS-986165 Dose 4
Specified dose of BMS-986165 on specified days.
Drug: BMS-986165
Experimental: BMS-986165 Dose 5
Specified dose of BMS-986165 on specified days.
Drug: BMS-986165
Placebo Comparator: Placebo
Specified dose of Placebo for BMS-986165 on specified days.
Drug: Placebo for BMS-986165



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931838


Locations
Show Show 76 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] August 23, 2016
Statistical Analysis Plan  [PDF] June 6, 2017

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02931838    
Other Study ID Numbers: IM011-011
First Posted: October 13, 2016    Key Record Dates
Results First Posted: November 27, 2020
Last Update Posted: November 27, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
BMS-986165
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action