Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02931838
Collaborator
(none)
268
76
6
12
3.5
0.3
Study Details
Study Description
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 |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
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
:
Nov 15, 2016
Actual Primary Completion Date
:
Nov 16, 2017
Actual Study Completion Date
:
Nov 16, 2017
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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) [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.
- Number of Participants With Adverse Events [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
- Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100. [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.
- Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate). [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.
- Change From Baseline in DLQI Scores on Day 85 [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)
- Change From Baseline in BSA on Day 85 [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.
- Trough Observed Plasma Concentration of BMS-986165 (Ctrough) [Days 8, 15, 29, 57, 85]
Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California Irvine | Irvine | California | United States | 92697 |
| 2 | University of California San Diego | San Diego | California | United States | 92122 |
| 3 | Renstar Medical Research | Ocala | Florida | United States | 34471 |
| 4 | Dermatologic Surgery Specialists, PC | Macon | Georgia | United States | 31217 |
| 5 | PMG Research of Christie Clinic, LLC | Champaign | Illinois | United States | 61820 |
| 6 | NorthShore University Health System | Skokie | Illinois | United States | 60077 |
| 7 | Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | United States | 46256 |
| 8 | Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center | Lebanon | New Hampshire | United States | 03756 |
| 9 | Piedmont Plastic Surgery & Dermatology - Charlotte/Blakeney Location | Charlotte | North Carolina | United States | 28277 |
| 10 | PMG Research of Rocky Mount, LLC | Rocky Mount | North Carolina | United States | 27804 |
| 11 | PMG Research of Wilmington, PLC | Wilmington | North Carolina | United States | 28401 |
| 12 | Central Sooner Research | Norman | Oklahoma | United States | 73071 |
| 13 | Health Concepts | Rapid City | South Dakota | United States | 57702 |
| 14 | Rivergate Dermatology Clinical Research Center, Pllc | Goodlettsville | Tennessee | United States | 37072 |
| 15 | Local Institution | Knoxville | Tennessee | United States | 37920 |
| 16 | Austin Dermatology Associates | Austin | Texas | United States | 78705 |
| 17 | Local Institution | Kogarah | New South Wales | Australia | 2217 |
| 18 | Local Institution | Wolloongabba | Queensland | Australia | 4102 |
| 19 | Local Institution | Melbourne | Victoria | Australia | 3053 |
| 20 | Local Institution | Nedlands | Western Australia | Australia | 6009 |
| 21 | Local Institution | Calgary | Alberta | Canada | T2G 1B1 |
| 22 | Local Institution | Edmonton | Alberta | Canada | T5K 1X3 |
| 23 | Local Institution | Vancouver | British Columbia | Canada | V5Z 4E8 |
| 24 | Local Institution | Hamilton | Ontario | Canada | L8N 1Y2 |
| 25 | Local Institution | Markham | Ontario | Canada | L3P 1X2 |
| 26 | Local Institution | Mississauga | Ontario | Canada | L5H 1G9 |
| 27 | Local Institution | Peterborough | Ontario | Canada | K9J 5K2 |
| 28 | Local Institution | Toronto | Ontario | Canada | M4W 2N2 |
| 29 | Local Institution | Waterloo | Ontario | Canada | N2J 1C4 |
| 30 | Local Institution | Windsor | Ontario | Canada | N8W 1E6 |
| 31 | Local Institution | Montreal | Quebec | Canada | H3H 1V4 |
| 32 | Local Institution | Dresden | Germany | 01097 | |
| 33 | Local Institution | Gera | Germany | 07548 | |
| 34 | Local Institution | Hamburg | Germany | 20253 | |
| 35 | Local Institution | Hamburg | Germany | 20354 | |
| 36 | Local Institution | Kiel | Germany | 24103 | |
| 37 | Local Institution | Kiel | Germany | 24105 | |
| 38 | Local Institution | Luebeck | Germany | 23538 | |
| 39 | Local Institution | Mahlow | Germany | 15831 | |
| 40 | Local Institution | Mainz | Germany | 55131 | |
| 41 | Local Institution | Schwerin | Germany | 19055 | |
| 42 | Local Institution | Stuttgart | Germany | 70178 | |
| 43 | Local Institution | Nagoya-shi | Aichi | Japan | 4678602 |
| 44 | Local Institution | Fukuoka City | Fukuoka | Japan | 814-0180 |
| 45 | Local Institution | Sapporo | Hokkaido | Japan | 060-0063 |
| 46 | Local Institution | Kobe | Hyogo | Japan | 6500017 |
| 47 | Local Institution | Kamigyo-ku | Kyoto | Japan | 602-8566 |
| 48 | Local Institution | Shimotsuke-shi | Tochigi | Japan | 3290498 |
| 49 | Local Institution | Minato-ku | Tokyo | Japan | 105-8471 |
| 50 | Local Institution | Shinagawa-Ku | Tokyo | Japan | 141-8625 |
| 51 | Local Institution | Shinjuku-ku | Tokyo | Japan | 160-0023 |
| 52 | Local Institution | Skinjuku-ku | Tokyo | Japan | 1690073 |
| 53 | Local Institution | Kumamoto | Japan | 8608556 | |
| 54 | Local Institution | Osaka | Japan | 5500012 | |
| 55 | Local Institution | Tokyo | Japan | 1738606 | |
| 56 | Local Institution | Daugavpils | Latvia | LV-5404 | |
| 57 | Local Institution | Riga | Latvia | LV-1001 | |
| 58 | Local Institution | Riga | Latvia | LV-1003 | |
| 59 | Local Institution | Riga | Latvia | LV-1011 | |
| 60 | Local Institution | Riga | Latvia | LV-1013 | |
| 61 | Local Institution | Ventspils | Latvia | LV3601 | |
| 62 | Local Institution | Zapopan | Jalisco | Mexico | 45030 |
| 63 | Local Institution | Monterey | Nuevo LEON | Mexico | 64460 |
| 64 | Local Institution | Krakow | Poland | 31-011 | |
| 65 | Local Institution | Lodz | Poland | 90-436 | |
| 66 | Local Institution | Lublin | Poland | 20-080 | |
| 67 | Local Institution | Osielsko | Poland | 86-031 | |
| 68 | Local Institution | Siedlce | Poland | 08 - 110 | |
| 69 | Local Institution | Skierniewice | Poland | 96-100 | |
| 70 | Local Institution | Warszawa | Poland | 00-660 | |
| 71 | Local Institution | Warszawa | Poland | 01-142 | |
| 72 | Local Institution | Warszawa | Poland | 01-817 | |
| 73 | Local Institution | Warszawa | Poland | 02-758 | |
| 74 | Local Institution | Warszawa | Poland | 02-777 | |
| 75 | Local Institution | Wroc?aw | Poland | 51-318 | |
| 76 | Local Institution | Wroclaw | Poland | 50368 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02931838
Other Study ID Numbers:
- IM011-011
First Posted:
Oct 13, 2016
Last Update Posted:
Nov 27, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 268 participants were randomized in the study; One participant was randomized but did not receive study drug due to being lost to follow-up |
| Arm/Group Title | Placebo | BMS-986165 3MG QOD | BMS-986165 3MG QD | BMS-986165 3MG BID | BMS-986165 6MG BID | BMS-986165 12MG QD |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo for BMS-986165 | BMS-986165 3mg capsules Every Other Day | BMS-986165 3mg capsules Every Day | BMS-986165 3mg capsules Twice Daily | BMS-986165 6mg capsules Twice Daily | BMS-986165 12mg capsules Every Day |
| Period Title: Overall Study | ||||||
| STARTED | 45 | 44 | 44 | 45 | 45 | 44 |
| COMPLETED | 31 | 34 | 36 | 42 | 39 | 42 |
| NOT COMPLETED | 14 | 10 | 8 | 3 | 6 | 2 |
Baseline Characteristics
| Arm/Group Title | Placebo | BMS-986165 3MG QOD | BMS-986165 3MG QD | BMS-986165 3MG BID | BMS-986165 6MG BID | BMS-986165 12MG QD | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo for BMS-986165 | BMS-986165 3mg capsules Every Other Day | BMS-986165 3 mg capsules every day | BMS-986165 3 mg capsules twice daily | BMS-986165 6 mg capsules twice daily | BMS-986165 12 mg capsules every day | Total of all reporting groups |
| Overall Participants | 45 | 44 | 44 | 45 | 45 | 44 | 267 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Years] |
46.4
(11.93)
|
41.0
(11.8)
|
45.0
(13.77)
|
45.6
(15.10)
|
42.8
(12.90)
|
46.6
(11.62)
|
44.6
(12.96)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
8
17.8%
|
8
18.2%
|
14
31.8%
|
19
42.2%
|
10
22.2%
|
14
31.8%
|
73
27.3%
|
| Male |
37
82.2%
|
36
81.8%
|
30
68.2%
|
26
57.8%
|
35
77.8%
|
30
68.2%
|
194
72.7%
|
| Race (NIH/OMB) (Count of Participants) | |||||||
| American Indian or Alaska Native |
0
0%
|
1
2.3%
|
0
0%
|
0
0%
|
1
2.2%
|
1
2.3%
|
3
1.1%
|
| Asian |
5
11.1%
|
6
13.6%
|
5
11.4%
|
5
11.1%
|
9
20%
|
6
13.6%
|
36
13.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
1
2.3%
|
0
0%
|
1
2.2%
|
0
0%
|
0
0%
|
2
0.7%
|
| White |
40
88.9%
|
35
79.5%
|
39
88.6%
|
39
86.7%
|
35
77.8%
|
37
84.1%
|
225
84.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
1
2.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.4%
|
Outcome Measures
| Title | 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) |
|---|---|
| Description | 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. |
| Time Frame | Day 1 to Day 85 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Randomized and Treated Participants |
| Arm/Group Title | Placebo | BMS-986165 3MG QOD | BMS-986165 3MG QD | BMS-986165 3MG BID | BMS-986165 6MG BID | BMS-986165 12MG QD |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo for BMS-986165 | BMS-986165 3mg capsules Every Other Day | BMS-986165 3 mg capsules every day | BMS-986165 3 mg capsules twice daily | BMS-986165 6 mg capsules twice daily | BMS-986165 12 mg capsules every day |
| Measure Participants | 45 | 44 | 44 | 45 | 45 | 44 |
| Number (95% Confidence Interval) [Percentage] |
6.7
|
9.1
|
38.6
|
68.9
|
66.7
|
75.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, BMS-986165 3MG QOD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4873 |
| Comments | Nominal p-value | |
| Method | Chi-squared | |
| Comments | P-value is from the Fishers Exact if at least one cell count is <5. Otherwise, p-value is from the Chi-Square test. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, BMS-986165 3MG QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0003 |
| Comments | Nominal p-value | |
| Method | Chi-squared | |
| Comments | P-value is from the Fishers Exact if at least one cell count is <5. Otherwise, p-value is from the Chi-Square test. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, BMS-986165 3MG BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Nominal p-value | |
| Method | Chi-squared | |
| Comments | P-value is from the Fishers Exact if at least one cell count is <5. Otherwise, p-value is from the Chi-Square test. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, BMS-986165 6MG BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | Nominal p-value | |
| Method | Chi-squared | |
| Comments | P-value is from the Fishers Exact if at least one cell count is <5. Otherwise, p-value is from the Chi-Square test. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, BMS-986165 12MG QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Nominal p-value | |
| Method | Chi-squared | |
| Comments | P-value is from the Fishers Exact if at least one cell count is <5. Otherwise, p-value is from the Chi-Square test. | |
| Title | Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100. |
|---|---|
| Description | 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. |
| Time Frame | Day 1 to Day 85 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Randomized and Treated Participants |
| Arm/Group Title | Placebo | BMS-986165 3MG QOD | BMS-986165 3MG QD | BMS-986165 3MG BID | BMS-986165 6MG BID | BMS-986165 12MG QD |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo for BMS-986165 | BMS-986165 3mg capsules Every Other Day | BMS-986165 3 mg capsules every day | BMS-986165 3 mg capsules twice daily | BMS-986165 6 mg capsules twice daily | BMS-986165 12 mg capsules every day |
| Measure Participants | 45 | 44 | 44 | 45 | 45 | 44 |
| % of participants with PASI-50 at Day 85 |
31.1
|
43.2
|
68.2
|
91.1
|
77.8
|
88.6
|
| % of participants with PASI-90 at Day 85 |
2.2
|
6.8
|
15.9
|
44.4
|
44.4
|
43.2
|
| % of participants with PASI-100 at Day 85 |
0
|
2.3
|
0
|
8.9
|
17.8
|
25.0
|
| Title | Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate). |
|---|---|
| Description | 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. |
| Time Frame | Day 1 to Day 85 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Randomized and Treated Participants |
| Arm/Group Title | Placebo | BMS-986165 3MG QOD | BMS-986165 3MG QD | BMS-986165 3MG BID | BMS-986165 6MG BID | BMS-986165 12MG QD |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo for BMS-986165 | BMS-986165 3mg capsules Every Other Day | BMS-986165 3 mg capsules every day | BMS-986165 3 mg capsules twice daily | BMS-986165 6 mg capsules twice daily | BMS-986165 12 mg capsules every day |
| Measure Participants | 45 | 44 | 44 | 45 | 45 | 44 |
| Number (95% Confidence Interval) [Percentage] |
6.7
|
20.5
|
38.6
|
75.6
|
64.4
|
75.0
|
| Title | Change From Baseline in DLQI Scores on Day 85 |
|---|---|
| Description | 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) |
| Time Frame | Day 1 to Day 85 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Randomized and Treated Participants |
| Arm/Group Title | Placebo | BMS-986165 3MG QOD | BMS-986165 3MG QD | BMS-986165 3MG BID | BMS-986165 6MG BID | BMS-986165 12MG QD |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo for BMS-986165 | BMS-986165 3mg capsules Every Other Day | BMS-986165 3 mg capsules every day | BMS-986165 3 mg capsules twice daily | BMS-986165 6 mg capsules twice daily | BMS-986165 12 mg capsules every day |
| Measure Participants | 45 | 44 | 44 | 45 | 45 | 44 |
| Mean (95% Confidence Interval) [Score] |
-2.85
|
-3.76
|
-6.07
|
-9.67
|
-8.38
|
-10.16
|
| Title | Change From Baseline in BSA on Day 85 |
|---|---|
| Description | 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. |
| Time Frame | Day 1 to Day 85 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Randomized and Treated Participants |
| Arm/Group Title | Placebo | BMS-986165 3MG QOD | BMS-986165 3MG QD | BMS-986165 3MG BID | BMS-986165 6MG BID | BMS-986165 12MG QD |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo for BMS-986165 | BMS-986165 3mg capsules Every Other Day | BMS-986165 3 mg capsules every day | BMS-986165 3 mg capsules twice daily | BMS-986165 6 mg capsules twice daily | BMS-986165 12 mg capsules every day |
| Measure Participants | 45 | 44 | 44 | 45 | 45 | 44 |
| Mean (95% Confidence Interval) [Percentage] |
-7.71
|
-5.50
|
-12.59
|
-18.60
|
-17.23
|
-15.16
|
| Title | Trough Observed Plasma Concentration of BMS-986165 (Ctrough) |
|---|---|
| Description | Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration |
| Time Frame | Days 8, 15, 29, 57, 85 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received any study medication and have any available concentration-time data. |
| Arm/Group Title | BMS-986165 3MG QOD | BMS-986165 3MG QD | BMS-986165 3MG BID | BMS-986165 6MG BID | BMS-986165 12MG QD |
|---|---|---|---|---|---|
| Arm/Group Description | BMS-986165 3mg capsules Every Other Day | BMS-986165 3 mg capsules every day | BMS-986165 3 mg capsules twice daily | BMS-986165 6 mg capsules twice daily | BMS-986165 12 mg capsules every day |
| Measure Participants | 44 | 44 | 44 | 45 | 44 |
| Mean (Standard Deviation) [ng/mL] |
2.024
(3.7061)
|
3.145
(3.1588)
|
14.819
(9.1410)
|
26.257
(14.6483)
|
17.824
(22.7536)
|
| Title | Number of Participants With Adverse Events |
|---|---|
| Description | 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 |
| Time Frame | Day 1 to day 115 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Randomized and Treated Participants |
| Arm/Group Title | Placebo | BMS-986165 3MG QOD | BMS-986165 3MG QD | BMS-986165 3MG BID | BMS-986165 6MG BID | BMS-986165 12MG QD |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo for BMS-986165 | BMS-986165 3mg capsules Every Other Day | BMS-986165 3 mg capsules every day | BMS-986165 3 mg capsules twice daily | BMS-986165 6 mg capsules twice daily | BMS-986165 12 mg capsules every day |
| Measure Participants | 45 | 44 | 44 | 45 | 45 | 44 |
| No. of participants with SAEs |
1
2.2%
|
1
2.3%
|
1
2.3%
|
1
2.2%
|
0
0%
|
0
0%
|
| No. of participants with AEs |
24
53.3%
|
26
59.1%
|
25
56.8%
|
29
64.4%
|
36
80%
|
34
77.3%
|
| No. of participants discontinued due to AEs |
2
4.4%
|
1
2.3%
|
2
4.5%
|
1
2.2%
|
3
6.7%
|
1
2.3%
|
Adverse Events
| Time Frame | 20 weeks (assessed up to November 16, 2017) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All Serious Adverse Events were collected from the date of participant's written consent until 30 days post discontinuation of dosing or participant's participation in the study if the last scheduled visit occurs at a later time. The collection of non-serious Adverse Event information began at initiation of study drug.Treatment Emergent AEs are determined from first dose to within 30 days after last dose. | |||||||||||
| Arm/Group Title | Placebo | BMS-986165 3mg QOD | BMS-986165 3mg QD | BMS-986165 3mg BID | BMS-986165 6mg BID | BMS-986165 12mg QD | ||||||
| Arm/Group Description | Placebo for BMS-986165 | BMS-986165 3mg capsules Every Other Day | BMS-986165 3 mg capsules every day | BMS-986165 3 mg capsules twice daily | BMS-986165 6 mg capsules twice daily | BMS-986165 12 mg capsules every day | ||||||
All Cause Mortality |
||||||||||||
| Placebo | BMS-986165 3mg QOD | BMS-986165 3mg QD | BMS-986165 3mg BID | BMS-986165 6mg BID | BMS-986165 12mg QD | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/45 (0%) | 0/44 (0%) | 0/44 (0%) | 0/45 (0%) | 0/45 (0%) | 0/44 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| Placebo | BMS-986165 3mg QOD | BMS-986165 3mg QD | BMS-986165 3mg BID | BMS-986165 6mg BID | BMS-986165 12mg QD | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/45 (2.2%) | 1/44 (2.3%) | 1/44 (2.3%) | 1/45 (2.2%) | 0/45 (0%) | 0/44 (0%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Haemorrhagic anaemia | 1/45 (2.2%) | 0/44 (0%) | 0/44 (0%) | 0/45 (0%) | 0/45 (0%) | 0/44 (0%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Haemorrhoidal haemorrhage | 1/45 (2.2%) | 0/44 (0%) | 0/44 (0%) | 0/45 (0%) | 0/45 (0%) | 0/44 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Gastroenteritis rotavirus | 0/45 (0%) | 1/44 (2.3%) | 0/44 (0%) | 0/45 (0%) | 0/45 (0%) | 0/44 (0%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Eye injury | 0/45 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/45 (0%) | 0/45 (0%) | 0/44 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Dizziness | 0/45 (0%) | 0/44 (0%) | 0/44 (0%) | 1/45 (2.2%) | 0/45 (0%) | 0/44 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Placebo | BMS-986165 3mg QOD | BMS-986165 3mg QD | BMS-986165 3mg BID | BMS-986165 6mg BID | BMS-986165 12mg QD | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/45 (28.9%) | 14/44 (31.8%) | 18/44 (40.9%) | 15/45 (33.3%) | 25/45 (55.6%) | 19/44 (43.2%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Aphthous ulcer | 0/45 (0%) | 0/44 (0%) | 0/44 (0%) | 3/45 (6.7%) | 0/45 (0%) | 1/44 (2.3%) | ||||||
| Diarrhoea | 2/45 (4.4%) | 1/44 (2.3%) | 1/44 (2.3%) | 2/45 (4.4%) | 2/45 (4.4%) | 4/44 (9.1%) | ||||||
| Nausea | 2/45 (4.4%) | 4/44 (9.1%) | 0/44 (0%) | 1/45 (2.2%) | 1/45 (2.2%) | 2/44 (4.5%) | ||||||
| Toothache | 1/45 (2.2%) | 1/44 (2.3%) | 1/44 (2.3%) | 1/45 (2.2%) | 3/45 (6.7%) | 1/44 (2.3%) | ||||||
| Infections and infestations | ||||||||||||
| Nasopharyngitis | 2/45 (4.4%) | 1/44 (2.3%) | 5/44 (11.4%) | 5/45 (11.1%) | 7/45 (15.6%) | 3/44 (6.8%) | ||||||
| Upper respiratory tract infection | 1/45 (2.2%) | 2/44 (4.5%) | 3/44 (6.8%) | 1/45 (2.2%) | 4/45 (8.9%) | 1/44 (2.3%) | ||||||
| Investigations | ||||||||||||
| Blood creatine phosphokinase increased | 1/45 (2.2%) | 0/44 (0%) | 1/44 (2.3%) | 0/45 (0%) | 4/45 (8.9%) | 7/44 (15.9%) | ||||||
| Blood immunoglobulin e increased | 1/45 (2.2%) | 3/44 (6.8%) | 2/44 (4.5%) | 0/45 (0%) | 2/45 (4.4%) | 3/44 (6.8%) | ||||||
| Nervous system disorders | ||||||||||||
| Headache | 2/45 (4.4%) | 4/44 (9.1%) | 4/44 (9.1%) | 3/45 (6.7%) | 3/45 (6.7%) | 2/44 (4.5%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| Acne | 0/45 (0%) | 1/44 (2.3%) | 0/44 (0%) | 1/45 (2.2%) | 2/45 (4.4%) | 4/44 (9.1%) | ||||||
| Pruritus | 2/45 (4.4%) | 0/44 (0%) | 1/44 (2.3%) | 1/45 (2.2%) | 3/45 (6.7%) | 2/44 (4.5%) | ||||||
| Psoriasis | 2/45 (4.4%) | 1/44 (2.3%) | 3/44 (6.8%) | 2/45 (4.4%) | 0/45 (0%) | 0/44 (0%) | ||||||
Limitations/Caveats
The limitations of this phase 2 trial include its small sample size and short duration; these results warrant confirmation in a larger trial of longer duration
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
| Name/Title | Bristol-Myers Squibb Study Director |
|---|---|
| Organization | Bristol-Myers Squibb |
| Phone | Please email |
| Clinical.Trials@bms.com |
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02931838
Other Study ID Numbers:
- IM011-011
First Posted:
Oct 13, 2016
Last Update Posted:
Nov 27, 2020
Last Verified:
Oct 1, 2020