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BMS-986166

Phase 2

Dermatitis, Atopic | Small molecule | Dermatology |Bristol-Myers Squibb Company|Last Updated: Oct 18, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986166 · 7 trials · 5 indications

Phase 2 1Phase 1 6
NCT05014438A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic DermatitisDermatitis, Atopic
COMPLETED17 Analytics
PHASE2COMPLETED
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
Dermatitis, Atopic
NCT0501443817
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Study Endpoints

Primary Endpoints

Mean Percentage Change From Baseline in EASI Score at Week 16
From baseline and 16 weeks

The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better.

Total amount of total radioactivity (TRA) recovered in urine (UR)
Up to 90 days
Total amount of TRA recovered in feces (FR)
Up to 90 days
Total amount of TRA recovered in urine and feces combined (RTotal)
Up to 90 days
Percent of TRA recovered in urine (%UR)
Up to 90 days
Percent of TRA recovered in feces (%FR)
Up to 90 days
Percent of TRA recovered in urine and feces combined (%TOTAL)
Up to 90 days
Maximum observed concentration (Cmax)
Up to 89 days
Time of maximum observed concentration (Tmax)
Up to 89 days
Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Up to 89 days
Geometric means ratio of Cmax of NET
Up to Day 26

Geometric means ratio of maximum observed plasma concentration (Cmax) of norethindrone (NET) when administered with versus without BMS-986166

Geometric means ratio of Cmax of EE
Up to Day 26

Geometric means ratio of maximum observed plasma concentration (Cmax) of ethinyl estradiol (EE) when administered with versus without BMS-986166

Geometric means ratio of AUC(0-T) of NET
Up to Day 26

Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for NET when administered with versus without BMS-986166

Geometric means ratio of AUC(0-T) of EE
Up to Day 26

Geometric means ratio of area under the plasma concentration-time curve from time zero to time of last quantifiable concentration for EE when administered with versus without BMS-986166

Geometric means ratio of AUC(INF) of NET
Up to Day 26

Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for NET administered with versus without BMS-986166

Geometric means ratio of AUC(INF) of EE
Up to Day 26

Geometric means ratio of area under the plasma concentration-time curve from time zero extrapolated to infinite time for EE when administered with versus without BMS-986166

Maximum observed plasma concentration (Cmax) of BMS-986166
Up to Day 22
Cmax of BMT-121795
Up to Day 22
Time of maximum observed plasma concentration (Tmax) of BMS-986166
Up to Day 22
Tmax of BMT-121795
Up to Day 22
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986166
Up to Day 22
AUC(0-T) of BMT-121795
Up to Day 22
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))of BMS-986166
Up to Day 22
AUC(INF) of BMT-121795
Up to Day 22
Terminal plasma half-life (T-HALF) of BMS-986166
Up to Day 22
T-HALF of BMT-121795
Up to Day 22
Apparent total body clearance (CL/F) of BMS-986166
Up to Day 22
Apparent volume of distribution (Vz/F) of BMS-986166
Up to Day 22
Ratio of BMT-121795 Cmax to parent Cmax corrected for molecular weight (MR_Cmax)
Up to Day 22
Ratio of BMT-121795 AUC(0-T) to parent AUC(0-T) corrected for molecular weight (MR_AUC(0-T))
Up to Day 22
Ratio of BMT-121795 AUC(INF) to parent AUC(INF) corrected for molecular weight (MR_AUC(INF))
Up to Day 22
Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax)
Day 1, Day 28
PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax)
Day 1, Day 28
PK parameters of BMS-986166: Area under the concentration-time curve within a dosing interval (AUC(TAU))
Day 1, Day 28
PK parameters of BMT-121795: Cmax
Day 1, Day 28
PK parameters of BMT-121795: Tmax
Day 1, Day 28
PK parameters of BMT-121795: AUC(TAU)
Day 1, Day 28
Incidence of All Adverse Events (AEs)
77 days

measured by number of patients

Incidence of Serious Adverse Events (SAEs)
77 days

measured by number of patients

Severity of all Adverse Events (AEs)
77 days

measured by investigator

Change from baseline in physical examination findings
77 days

measured by investigator

Change from baseline in electrocardiogram (ECG) results
77 days

measured by ECG

Change from baseline in continuous cardiac monitoring data
15 days

measured with external monitoring device

Change from baseline in clinical laboratory test results
77 days

measured by serum chemistry, hematology, serology and urinalysis results

Change from baseline in body temperature
77 days

measured in degrees Celsius or Fahrenheit

Change from baseline in respiratory rate
77 days

measured by investigator

Change from baseline in seated blood pressure
77 days

measured by investigator

Change from baseline in heart rate
77 days

measured by investigator

Severity of all All Adverse Events (AEs)
Baseline Day -1 to Day 65
Change from baseline in electrocardiogram(ECG) results
Baseline Day -1 to Day 35

Secondary Endpoints

Percentage of Participants Exhibiting a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 (Cleared) or 1 (Almost Cleared) AND a ≥ 2 Point Reduction From Baseline at Week 16
From baseline and 16 weeks
Percentage of Participants Exhibiting a ≥ 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16
From baseline and 16 weeks
Percentage of Participants Exhibiting a ≥ 4-point Improvement From Baseline in Pruritus NRS at Week 16
From baseline and 16 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
Treatment BMS-986166 Dose 1EXPERIMENTAL -
Treatment BMS-986166 Dose 2EXPERIMENTAL -
Treatment BMS-986166 Dose 3EXPERIMENTAL -
Treatment BranebrutinibEXPERIMENTAL -
Treatment Group 1: BMS-986166EXPERIMENTAL -
BMS-986166 + Oral contraceptiveEXPERIMENTAL -
BMS-986166EXPERIMENTAL -
BMS-986166 + ItraconazoleEXPERIMENTAL -
BMS-986166 + PhenytoinEXPERIMENTAL -
BMS-986166 + GemfibrozilEXPERIMENTAL -
Panel 1: Dose 1EXPERIMENTAL -
Panel 2: Dose 2EXPERIMENTAL -
Dose Panel 1EXPERIMENTALBMS-986166 or Placebo matching BMS-986166
Dose Panel 2EXPERIMENTALBMS-986166 or Placebo matching BMS-986166
Dose Panel 3EXPERIMENTALBMS-986166 or Placebo matching BMS-986166
Dose Panel 4EXPERIMENTALBMS-986166 or Placebo matching BMS-986166 Multiple ascending solid dose formulation as specified
Dose Panel 5a/b/cEXPERIMENTALBMS-986166 Single oral solid dose formulation under fasting/fed/fasting with famotidine conditions

Interventions

NameTypeDescription
BMS-986166DRUGSpecified dose on specified days
BranebrutinibDRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
BisacodylDRUGSpecified dose on specified days
Oral contraceptiveDRUGSpecified dose on specified days
ItraconazoleDRUGSpecified dose on specified days
Extended Phenytoin SodiumDRUGSpecified dose on specified days
GemfibrozilDRUGSpecified dose on specified days
Placebo matching BMS-986166OTHERSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Chronic atopic dermatitis (AD) diagnosed according to the Eichenfield modification of Hanifin's and Rajka's (E-HR) criteria at Screening * Disease duration of at least 24 months since diagnosis by any criteria * Documented history of inadequate control of AD by a stable regime...

Countries:United StatesAustraliaAustriaCanadaGermanyPolandSpain
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Frequently asked questions about BMS-986166

What is BMS-986166 used for?

BMS-986166 is an investigational small molecule being developed by Bristol-Myers Squibb for dermatology and inflammatory conditions, including atopic dermatitis and ulcerative colitis. It is currently in Phase 2 clinical development, though the completed trials listed are Phase 1 studies in healthy volunteers.

Who makes BMS-986166?

BMS-986166 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and drug levels in healthy participants.

What phase is BMS-986166 in?

BMS-986166 is in Phase 2 clinical development. The completed trials on record are Phase 1 studies, which have finished, and no active trials are currently listed. The drug is investigational and not yet approved.

What clinical trials is BMS-986166 in?

BMS-986166 has completed four Phase 1 trials: NCT04934696, NCT04956627, NCT04965402, and NCT05409157. These studies evaluated drug levels, drug interactions, and safety in healthy participants, including Japanese and male participants.

Is BMS-986166 the same as any other drug?

No alternative names for BMS-986166 have been disclosed. The drug is identified solely by its code name BMS-986166 in clinical trial records and is not known to be marketed under any other brand name.

What does BMS-986166 target?

The molecular target of BMS-986166 has not been specified in the available information. It is described as a small molecule being studied for atopic dermatitis and ulcerative colitis, but its specific mechanism of action is not detailed.