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

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ClinicalTrials.gov Identifier: NCT02931838
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : November 16, 2018
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 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. Proportion of subjects reaching a 75% reduction in Psoriasis Area and Severity Index (PASI-75) [ Time Frame: Day 1 to Day 85 ]
  2. Number of adverse events (AEs) [ Time Frame: Day 1 to 115 ]

Secondary Outcome Measures :
  1. Proportion of subjects at week 12 with PASI-50 [ Time Frame: Baseline to Week 12 ]
  2. Proportion of subjects at week 12 with PASI-75 [ Time Frame: Baseline to Week 12 ]
  3. Proportion of subjects at week 12 with PASI-90 [ Time Frame: Baseline to Week 12 ]
  4. Proportion of subjects at week 12 with PASI-100 [ Time Frame: Baseline to Week 12 ]
  5. static Physician Global Assessment score (sPGA) [ Time Frame: Day 1 to Day 85 ]
  6. Dermatology Life Quality Index score (DLQI) [ Time Frame: Day 1 to Day 85 ]
  7. Trough observed plasma concentration of BMS-986165 (Ctrough) [ Time Frame: Day 1 to Day 85 ]


Information from the National Library of Medicine

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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


  Show 77 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02931838     History of Changes
Other Study ID Numbers: IM011-011
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases