Trial · NCT03611751

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

NCT03611751, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2022-12-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT03611751. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03611751

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT03611751
Status: Completed
Phases: Phase 3
Enrollment: 1,020 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Psoriasis
Interventions: BMS-986165, Placebo, Apremilast
First posted: 2018-08-02
Last updated: 2022-12-20
Other registries' IDs: eudract:2018-001925-24
Results first posted: 2022-12-20

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)	Week 16	The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least a 2-point improvement from baseline using the non-responder imputation (NRI) method. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Primary	The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)	Baseline and Week 16	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Secondary	The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)	Baseline and Week 16	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Secondary	The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)	Baseline and Week 16	The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Secondary	The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)	Week 16	The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Secondary	Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16	Baseline and Week 16	PSSD assesses the severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Both symptom and sign scores are derived by averaging the questions and multiplying by 10. A total PSSD score ranging 0-100 will be derived from taking the average of the symptom and sign scores. 0 represents the least severe symptom/sign and 100 represents the most severe. Baseline is defined as the measurement at the randomization visit (Week 0). A modified observation carried forward (mBOCF) approach will be used for missing data. The baseline observation will be carried forward for participants who discontinue study treatment for all analysis weeks after the assessment time point of discontinuation due to lack of efficacy and AEs.
Secondary	Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16	Week 16	Psoriasis Symptoms and Signs Diary (PSSD) is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0 to 10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable) where the symptoms summary score is derived from the average of the scores. A higher score indicates more severe disease. PSSD 0 is the response as a number of participants who experience a PSSD symptom score that determines psoriasis severity as 0 among participants with a baseline PSSD symptom score \>= 1 using the non-responder imputation (NRI) method.
Secondary	The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)	Week 16	The scalp specific Physician's Global Assessment (ss-PGA) evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score ≥3 . Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Secondary	The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)	Week 16	The DLQI is a participant-reported quality of life index which consists of 10 questions concerning how much skin problems affect 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 where 0 = not at all, 1 =a little, 2 = a lot, or 3 = very much. The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline DLQI score ≥2. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
Secondary	The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)	Week 16	The Physician Global Assessment- Fingernails (PGA-F) evaluates the overall condition of the fingernails and is rated on a 5-point scale:0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score \>=3. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)	Week 16	All randomized participants in the BMS-986165 and Placebo arms	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)	Baseline and Week 16	All randomized participants in the BMS-986165 and Placebo arms	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)	Baseline and Week 16	All randomized participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)	Baseline and Week 16	All randomized participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)	Week 16	All randomized participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16	Baseline and Week 16	All randomized participants with evaluable baseline and week 16 PSSD scores.	Score on a scale	MEAN
SECONDARY	Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16	Week 16	All randomized participants with a baseline PSSD symptom score ≥ 1	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)	Week 16	All randomized participants with a baseline ss-PGA score \>=3	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)	Week 16	All randomized participants with a baseline DLQI score \>=2. Pre-specified for data to be collected only in BMS-986165 and Placebo arms.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)	Week 16	All randomized participants with a baseline PGA-F score \>=3. Pre-specified for data to be collected only in BMS-986165 and Placebo arms.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)	BMS-986165	253	Participants
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)	Placebo	22	Participants
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)	BMS-986165	271	Participants
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)	Placebo	24	Participants
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)	BMS-986165	138	Participants
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)	Placebo	7	Participants
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)	Apremilast	46	Participants
The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)	BMS-986165	52	Participants
The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)	Placebo	3	Participants
The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)	Apremilast	11	Participants

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Pre-treatment	STARTED	BMS-986165	511
Pre-treatment	STARTED	Placebo	255
Pre-treatment	STARTED	Apremilast	254
Pre-treatment	COMPLETED	BMS-986165	510
Pre-treatment	COMPLETED	Placebo	254
Pre-treatment	COMPLETED	Apremilast	254
Pre-treatment	NOT COMPLETED	BMS-986165	1
Pre-treatment	NOT COMPLETED	Placebo	1
Pre-treatment	NOT COMPLETED	Apremilast	0
Treatment Week 0 - Week 16	STARTED	BMS-986165	510

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events288

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	BMS-986165 (Week 0 up to Week 16)	24	510
other	Diarrhoea	Gastrointestinal disorders	Placebo (Week 0 up to Week 16)	19	254
other	Diarrhoea	Gastrointestinal disorders	Apremilast (Week 0 up to Week 16)	33	254
other	Diarrhoea	Gastrointestinal disorders	BMS-986165 (Week 0 up to Week 52)	39	833
other	Diarrhoea	Gastrointestinal disorders	Placebo (Week 0 up to Week 52)	22	501
other	Diarrhoea	Gastrointestinal disorders	Apremilast (Week 0 up to Week 52)	35	254
other	Nausea	Gastrointestinal disorders	BMS-986165 (Week 0 up to Week 16)	7	510
other	Nausea	Gastrointestinal disorders	Placebo (Week 0 up to Week 16)	3	254
other	Nausea	Gastrointestinal disorders	Apremilast (Week 0 up to Week 16)	23	254
other	Nausea	Gastrointestinal disorders	BMS-986165 (Week 0 up to Week 52)	13	833

1 to 10 of 288Source ClinicalTrials.gov

See all 288 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BMS-986165 (Week 0 up to Week 16)	1	511
Total, all-cause mortality	Placebo (Week 0 up to Week 16)	0	255
Total, all-cause mortality	Apremilast (Week 0 up to Week 16)	1	254
Total, all-cause mortality	BMS-986165 (Week 0 up to Week 52)	2	834
Total, all-cause mortality	Placebo (Week 0 up to Week 52)	0	502
Total, all-cause mortality	Apremilast (Week 0 up to Week 52)	1	254
Total, other adverse events	BMS-986165 (Week 0 up to Week 16)	114	510
Total, other adverse events	Placebo (Week 0 up to Week 16)	61	254
Total, other adverse events	Apremilast (Week 0 up to Week 16)	86	254
Total, other adverse events	BMS-986165 (Week 0 up to Week 52)	249	833

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
37150956	DERIVED	PubMed
39080153	DERIVED	PubMed
39602111	DERIVED	PubMed
40113724	DERIVED	PubMed
40445270	DERIVED	PubMed
41350512	DERIVED	PubMed
42563042	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons9

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
BMS-986165 vs Apremilast: The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1)	Trial comparisons
BMS-986165 vs Apremilast: The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75)	Trial comparisons
BMS-986165 vs Placebo: The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)	Trial comparisons
BMS-986165 vs Apremilast: The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)	Trial comparisons
BMS-986165 vs Placebo: The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)	Trial comparisons
BMS-986165 vs Apremilast: The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)	Trial comparisons
BMS-986165 vs Placebo: The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)	Trial comparisons
BMS-986165 vs Apremilast: The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)	Trial comparisons
BMS-986165 vs Placebo: The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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