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NCT02931838

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

Completed Phase 2 Results posted Last updated 27 November 2020
What this trial tests

Phase 2 trial testing BMS-986165 in Psoriasis in 268 participants. Completed in 16 November 2017.

Timeline
15 November 2016
Primary endpoint
16 November 2017
16 November 2017

Quick facts

Lead sponsorBristol-Myers Squibb
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment268
Start date15 November 2016
Primary completion16 November 2017
Estimated completion16 November 2017
Sites76 locations across Japan, Germany, Poland, Mexico, Canada, Australia, United States, Latvia

Drugs / interventions tested

Conditions studied

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 18 to 70, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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) Primary · 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.

GroupValue95% CI
Placebo6.71.4 – 18.3
BMS-986165 3MG QOD9.12.5 – 21.7
BMS-986165 3MG QD38.624.4 – 54.5
BMS-986165 3MG BID68.953.4 – 81.8
BMS-986165 6MG BID66.751.0 – 80.0
BMS-986165 12MG QD75.059.7 – 86.8
Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100. Secondary · 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 sign

% of participants with PASI-50 at Day 85
GroupValue95% CI
Placebo31.118.2 – 46.6
BMS-986165 3MG QOD43.228.3 – 59.0
BMS-986165 3MG QD68.252.4 – 81.4
BMS-986165 3MG BID91.178.8 – 97.5
BMS-986165 6MG BID77.862.9 – 88.8
BMS-986165 12MG QD88.675.4 – 96.2
% of participants with PASI-90 at Day 85
GroupValue95% CI
Placebo2.20.1 – 11.8
BMS-986165 3MG QOD6.81.4 – 18.7
BMS-986165 3MG QD15.96.6 – 30.1
BMS-986165 3MG BID44.429.6 – 60.0
BMS-986165 6MG BID44.429.6 – 60.0
BMS-986165 12MG QD43.228.3 – 59.0
% of participants with PASI-100 at Day 85
GroupValue95% CI
Placebo00.0 – 7.9
BMS-986165 3MG QOD2.30.1 – 12.0
BMS-986165 3MG QD00.0 – 8.0
BMS-986165 3MG BID8.92.5 – 21.2
BMS-986165 6MG BID17.88.0 – 32.1
BMS-986165 12MG QD25.013.2 – 40.3
Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate). Secondary · 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.

GroupValue95% CI
Placebo6.71.4 – 18.3
BMS-986165 3MG QOD20.59.8 – 35.3
BMS-986165 3MG QD38.624.4 – 54.5
BMS-986165 3MG BID75.660.5 – 87.1
BMS-986165 6MG BID64.448.8 – 78.1
BMS-986165 12MG QD75.059.7 – 86.8
Change From Baseline in DLQI Scores on Day 85 Secondary · 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)

GroupValue95% CI
Placebo-2.85-4.33 – -1.37
BMS-986165 3MG QOD-3.76-5.15 – -2.38
BMS-986165 3MG QD-6.07-8.07 – -4.08
BMS-986165 3MG BID-9.67-11.42 – -7.93
BMS-986165 6MG BID-8.38-10.72 – -6.03
BMS-986165 12MG QD-10.16-12.27 – -8.06
Change From Baseline in BSA on Day 85 Secondary · 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 ther

GroupValue95% CI
Placebo-7.71-11.88 – -3.54
BMS-986165 3MG QOD-5.50-8.17 – -2.83
BMS-986165 3MG QD-12.59-18.28 – -6.89
BMS-986165 3MG BID-18.60-23.69 – -13.52
BMS-986165 6MG BID-17.23-20.85 – -13.60
BMS-986165 12MG QD-15.16-18.64 – -11.69
Trough Observed Plasma Concentration of BMS-986165 (Ctrough) Secondary · Days 8, 15, 29, 57, 85

Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration

GroupValue95% CI
BMS-986165 3MG QOD2.024± 3.7061
BMS-986165 3MG QD3.145± 3.1588
BMS-986165 3MG BID14.819± 9.1410
BMS-986165 6MG BID26.257± 14.6483
BMS-986165 12MG QD17.824± 22.7536
Number of Participants With Adverse Events Primary · 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

No. of participants with SAEs
GroupValue95% CI
Placebo1
BMS-986165 3MG QOD1
BMS-986165 3MG QD1
BMS-986165 3MG BID1
BMS-986165 6MG BID0
BMS-986165 12MG QD0
No. of participants with AEs
GroupValue95% CI
Placebo24
BMS-986165 3MG QOD26
BMS-986165 3MG QD25
BMS-986165 3MG BID29
BMS-986165 6MG BID36
BMS-986165 12MG QD34
No. of participants discontinued due to AEs
GroupValue95% CI
Placebo2
BMS-986165 3MG QOD1
BMS-986165 3MG QD2
BMS-986165 3MG BID1
BMS-986165 6MG BID3
BMS-986165 12MG QD1

Adverse events — posted to ClinicalTrials.gov

Time frame: 20 weeks (assessed up to November 16, 2017). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo
Serious: 1/45 (2%)
Deaths: 0/45
BMS-986165 3mg QOD
Serious: 1/44 (2%)
Deaths: 0/44
BMS-986165 3mg QD
Serious: 1/44 (2%)
Deaths: 0/44
BMS-986165 3mg BID
Serious: 1/45 (2%)
Deaths: 0/45
BMS-986165 6mg BID
Serious: 0/45 (0%)
Deaths: 0/45
BMS-986165 12mg QD
Serious: 0/44 (0%)
Deaths: 0/44

Serious adverse events (5 terms)

ReactionSystemPlaceboBMS-986165 3mg QODBMS-986165 3mg QDBMS-986165 3mg BIDBMS-986165 6mg BIDBMS-986165 12mg QD
Haemorrhagic anaemiaBlood and lymphatic system disorders——————
Haemorrhoidal haemorrhageGastrointestinal disorders——————
Gastroenteritis rotavirusInfections and infestations——————
Eye injuryInjury, poisoning and procedural complications——————
DizzinessNervous system disorders——————
Other adverse events (12 terms — click to expand)

ReactionSystemPlaceboBMS-986165 3mg QODBMS-986165 3mg QDBMS-986165 3mg BIDBMS-986165 6mg BIDBMS-986165 12mg QD
NasopharyngitisInfections and infestations——————
Blood creatine phosphokinase increasedInvestigations——————
DiarrhoeaGastrointestinal disorders——————
NauseaGastrointestinal disorders——————
Upper respiratory tract infectionInfections and infestations——————
HeadacheNervous system disorders——————
AcneSkin and subcutaneous tissue disorders——————
Aphthous ulcerGastrointestinal disorders——————
ToothacheGastrointestinal disorders——————
Blood immunoglobulin e increasedInvestigations——————
PruritusSkin and subcutaneous tissue disorders——————
PsoriasisSkin and subcutaneous tissue disorders——————

Most-reported serious reactions: Haemorrhagic anaemia, Haemorrhoidal haemorrhage, Gastroenteritis rotavirus, Eye injury, Dizziness.

Data from ClinicalTrials.gov NCT02931838 adverse events section.

Sponsor's own description

A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases.
    Schwartz DM, Kanno Y, Villarino A, Ward M, et al · · 2017 · cited 308× · PMID 29282366 · DOI 10.1038/nrd.2017.267
  2. Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis.
    Papp K, Gordon K, Thaçi D, Morita A, et al · · 2018 · cited 285× · PMID 30205746 · DOI 10.1056/nejmoa1806382
  3. Targeting the Janus Kinase Family in Autoimmune Skin Diseases.
    Howell MD, Kuo FI, Smith PA. · · 2019 · cited 180× · PMID 31649667 · DOI 10.3389/fimmu.2019.02342
  4. Selective JAKinibs: Prospects in Inflammatory and Autoimmune Diseases.
    T Virtanen A, Haikarainen T, Raivola J, Silvennoinen O. · · 2019 · cited 164× · PMID 30701418 · DOI 10.1007/s40259-019-00333-w
  5. Old and New Biological Therapies for Psoriasis.
    Rønholt K, Iversen L. · · 2017 · cited 152× · PMID 29104241 · DOI 10.3390/ijms18112297
  6. Deucravacitinib: First Approval.
    Hoy SM. · · 2022 · cited 113× · PMID 36401743 · DOI 10.1007/s40265-022-01796-y
  7. Tyrosine Kinases in Autoimmune and Inflammatory Skin Diseases.
    Szilveszter KP, Németh T, Mócsai A. · · 2019 · cited 102× · PMID 31447854 · DOI 10.3389/fimmu.2019.01862
  8. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
    Sbidian E, Chaimani A, Garcia-Doval I, Doney L, et al · · 2022 · cited 84× · PMID 35603936 · DOI 10.1002/14651858.cd011535.pub5

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Other trials of BMS-986165

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02931838.

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