Trial record 1 of 1 for:
NCT03624127
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)
|
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: NCT03624127 |
|
Recruitment Status :
Active, not recruiting
First Posted : August 9, 2018
Last Update Posted : September 1, 2020
|
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 : | August 3, 2018 |
| Estimated Primary Completion Date : | August 30, 2020 |
| Estimated Study Completion Date : | August 30, 2020 |
| 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 |
Primary Outcome Measures :
- 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.
- 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 :
- Percentage of participants who achieve PASI 90 [ Time Frame: Baseline to Week 16 ]
- Percentage of participants who achieve PASI 100 [ Time Frame: Baseline to Week 16 ]
- 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).
- 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.
- 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).
- 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.
- 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.
- Percentage of participants who achieve PASI 75 [ Time Frame: Baseline to Week 52 ]
- Percentage of participants who achieve PASI 90 [ Time Frame: Baseline to Week 52 ]
- Percentage of participants who achieve sPGA score of 0 or 1 response [ Time Frame: Baseline to Week 52 ]
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.
| 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
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
Locations
Show 165 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT03624127 |
| Other Study ID Numbers: |
IM011-046 2018-001926-25 ( EudraCT Number ) |
| First Posted: | August 9, 2018 Key Record Dates |
| Last Update Posted: | September 1, 2020 |
| Last Verified: | August 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Apremilast BMS-986165 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 Dermatologic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |