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Trial record 1 of 1 for:    NCT03624127
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An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate to Severe Plaque Psoriasis (POETYK-PSO-1)

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ClinicalTrials.gov Identifier: NCT03624127
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: BMS-986165 Other: Placebo Drug: Apremilast Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
Actual Study Start Date : July 17, 2018
Estimated Primary Completion Date : July 19, 2020
Estimated Study Completion Date : July 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986165
BMS-986165 oral administration
 Drug: BMS-986165
Specified dose on specified days
Placebo Comparator: Placebo
Placebo oral administration
 Other: Placebo
Specified dose on specified days
Active Comparator: Active comparator
Active comparator oral administration
 Drug: Apremilast
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants who achieve static Physician's Global Assessment (sPGA) score of 0 to 1 response [ Time Frame: Baseline to Week 16 ]
    The sPGA score is the investigator's assessment of a participant's psoriasis lesions at a given point in time. Overall lesions are graded and averaged for thickness, erythema, and scaling based on a 0 (normal) to 4 (severe) scale.

  2. Percentage of participants who achieve PASI 75 (75% reduction in Psoriasis Area and Severity Index) [ Time Frame: Baseline to Week 16 ]
    The PASI is a scoring system used by investigators to grade the severity and extent of psoriatic lesions. In the PASI system, the body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved and scored for erythema, induration, and scaling to generate a composite PASI score that ranges from 0 (normal) to 72 (most severe).


Secondary Outcome Measures :
  1. Percentage of participants who achieve PASI 90 [ Time Frame: Baseline to Week 16 ]
  2. Percentage of participants who achieve PASI 100 [ Time Frame: Baseline to Week 16 ]
  3. Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) score [ Time Frame: Baseline to Week 16 ]
    The PSSD is a participant questionnaire to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consists of 11 items covering various symptoms and patient-observable signs and averaged to generate a score from 0 (normal) to 10 (most severe).

  4. Percentage of participants who achieve scalp specific Physician's Global Assessment (ss-PGA) score 0 or 1 among participants with a baseline ss-PGA score ≥3 [ Time Frame: Baseline to Week 16 ]
    The ss-PGA measure is used to evaluate the overall disease severity of scalp psoriasis. Lesions are assessed by investigators in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 0 (normal) to 4 (severe) scale.

  5. Change from baseline in Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline to Week 16 ]
    The DLQI is a 10-item participant questionnaire that measures the impact of skin disease on a participant's quality of life. Each question is evaluated on a 4-point scale ranging from 0 to 3 and added to generate a DLQI total score ranging from 0 (normal) to 30 (severe).

  6. Percentage of participants who achieve Physician Global Assessment-Fingernails (PGA-F) score 0 or 1 among participants with a baseline PGA-F score ≥3 [ Time Frame: Baseline to Week 16 ]
    The PGA-F score is a measure of the overall condition of the fingernails in participants who have psoriasis fingernail involvement. The nail bed and nail matrix of each fingernail are rated by the investigator on a 0 (normal) to 4 (severe) scale.

  7. Percentage of participants who achieve palmoplantar Physician's Global Assessment (pp-PGA) score 0 or 1 among participants with a baseline pp- PGA score ≥3 [ Time Frame: Baseline to Week 16 ]
    The pp-PGA score is a measure of the overall severity of psoriasis lesions involving the palms and soles. The investigator assesses overall severity based on a 0 (normal) to 4(severe) scale.

  8. Percentage of participants who achieve PASI 75 [ Time Frame: Baseline to Week 52 ]
  9. Percentage of participants who achieve PASI 90 [ Time Frame: Baseline to Week 52 ]
  10. Percentage of participants who achieve sPGA score of 0 or 1 response [ Time Frame: Baseline to Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (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:

  • Plaque psoriasis for at least 6 months
  • Moderate to severe disease
  • Candidate for phototherapy or systemic therapy

Exclusion Criteria:

  • Other forms of psoriasis
  • History of recent infection
  • Prior exposure to BMS-986165 or active comparator

Other protocol defined inclusion/exclusion criteria may apply

Contacts and Locations
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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): NCT03624127


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03624127     History of Changes
Other Study ID Numbers: IM011-046
2018-001926-25 ( EudraCT Number )
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

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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
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents