A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis

September 26, 2019 updated by: Bristol-Myers Squibb

A Double-Blind Randomized Placebo-Controlled Single and Multiple Ascending Doses Study of the Safety and Tolerability, Pharmacokinetics (Including Bioavailability Comparison and Food Effect) and Pharmacodynamics of Oral BMS-986251 Administration in Healthy Subjects, With Efficacy Assessment of Multiple Doses in Patients With Moderate-to-Severe Psoriasis

The purpose of this study is to investigate experimental medication BMS-986251 taken by mouth in healthy patients and patients with average to very serious Psoriasis (a condition characterized by itchy, dry skin with a scaly rash).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9728 NZ
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria (Healthy Patients):

  • Males and females, ages 18 to 55 years, inclusive, at screening
  • Healthy subjects, as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, vital signs, and clinical laboratory results
  • Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening
  • Body weight between 55 kg and 105 kg, inclusive, at screening
  • Women must not be breastfeeding

Exclusion Criteria (Healthy Patients):

  • Previous participation in the current study
  • Participation in a drug study or exposure to any investigational drug or placebo within 2 months prior to (the first) drug administration in the current study
  • Employees of PRA or the Sponsor and their relatives
  • Any significant acute or chronic medical condition that presents a potential risk to the subject and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
  • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect pharmacokinetics; history of cholecystectomy is not allowed

Inclusion Criteria (Psoriasis Patients):

  • Males and females, ages 18 to 70 years, inclusive, at screening
  • BMI of 18.0 to 35.0 kg/m2, inclusive, at screening
  • Body weight between 55 kg and 120 kg, inclusive, at screening
  • Diagnosed with stable chronic plaque psoriasis, for at least 6 months prior to screening and be candidates for either photo-therapy or systemic treatment

  • Moderate-to-severe intensity of psoriasis as defined by:

    1. Affected body surface area (BSA) of ≥10%
    2. Psoriasis Area and Severity Index (PASI) ≥12
    3. Physician Global Assessment (PGA; 6-point scale) ≥3

Exclusion Criteria (Psoriasis Patients):

  • Previous participation in the current study
  • Participation in a drug study or exposure to any investigational drug or placebo within 2 months prior to (the first) drug administration in the current study
  • Employees of PRA or the Sponsor and their relatives
  • Any significant acute or chronic medical condition that presents a potential risk to the subject and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
  • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect pharmacokinetics; history of cholecystectomy is not allowed

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A Single Ascending Dose (SAD) in Healthy Patients
Healthy patient will receive single escalating oral doses of BMS-986251 or placebo
Drug: BMS-986251
Escalating oral dose
Other: Placebo
Escalating oral dose
Experimental: Part B Multiple Ascending Dose (MAD) in Healthy Patients
Healthy patients will receive daily escalating oral doses of BMS-986251 or placebo
Drug: BMS-986251
Escalating oral dose
Other: Placebo
Escalating oral dose
Experimental: Part C Multiple Dosing in Psoriasis Patients
Psoriasis patients will receive daily escalating oral doses of BMS-986251 or placebo
Drug: BMS-986251
Escalating oral dose
Other: Placebo
Escalating oral dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants That Experienced the Following: Serious Adverse Events (SAEs), Death or an Adverse Event (AE) Leading to Study Discontinuation
Time Frame: AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with the treatment. A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose results in death or is life-threatening or requires inpatient hospitalization
AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B)
Number of Participants With Potentially Clinically Significant Changes in Vital Signs
Time Frame: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9 and 11; Part B: Days 1, 2-13, 15, 16, 18, 20, 24
Vital signs (Systolic and diastolic blood pressure and pulse) were recorded after the participant had been resting for at least 5 minutes in the supine position.
Part A: Days 1, 2, 3, 4, 5, 6, 7, 9 and 11; Part B: Days 1, 2-13, 15, 16, 18, 20, 24
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time Frame: Part A: Days 1, 2, 3,5, 7 and 11; Part B: Days 1, 2, 4, 6, 8, 10, and 12,24
The following ECG parameters were recorded: heart rate, PR-interval, QRS-duration, QT-interval, QTcinterval, (Fridericia's) and the interpretation of the ECG profile by the Investigator
Part A: Days 1, 2, 3,5, 7 and 11; Part B: Days 1, 2, 4, 6, 8, 10, and 12,24
Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Parameters
Time Frame: Part A: Days 2, 4, 7 and 11; Part B: Days 3, 7, 10, 14, 16, 24

Hematology: Hemoglobin, Hematocrit, Total leukocyte count, including differential Platelet count, Red blood cell count, Reticulocyte count; Chemistry:

Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Total bilirubin, Direct bilirubin, Alkaline phosphatase, Lactate dehydrogenase , (LDH), Creatinine, Urea, Uric acid, Fasting glucose, High sensitivity C-reactive protein (hs-CRP), Total protein, Albumin Sodium, Potassium, Chloride, Calcium Inorganic phosphate, Magnesium, Creatine kinase, Creatinine clearance (CLcr)- screening only, Cholesterol Triglycerides, High-density lipoprotein (HDL), Low-density lipoprotein (LDL), Urinalysis: Protein, Glucose, Blood Leukocyte esterase, Specific gravity, pH,Microscopic examination of the sediment if blood, protein or leukocytes esterase are positive on the dipstick; Other Analyses: Urine test for alcohol, Urine test for drugs of abuse, Pregnancy test
Part A: Days 2, 4, 7 and 11; Part B: Days 3, 7, 10, 14, 16, 24
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14
Time of Maximum Observed Plasma Concentration (Tmax)
Time Frame: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-t)]
Time Frame: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] (Part A)
Time Frame: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11
Terminal Elimination Half-life, Calculated as 0.693/Kel [t(1/2)]
Time Frame: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 14
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 14
Apparent (Oral) Clearance (CL/F) Calculated as Dose/[AUC(0-inf)] for Single Dose
Time Frame: Part A: Day 1, Part B: Day 14
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part A: Day 1, Part B: Day 14
Apparent Volume of Distribution at Terminal Phase [V(z)/F]
Time Frame: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 14
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 14
Cumulative Urinary Excretion (of the Unchanged Drug) [Ae(t)]
Time Frame: Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14
Summary of BMS-986251 Excretion Parameters in Urine. PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14
Amount Excreted Unchanged in Urine (% of Dose) [Fe(Urine)%]
Time Frame: Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14
Summary of BMS-986251 Excretion Parameters in Urine. PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14
Renal Clearance [CL(R)]
Time Frame: Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14
Summary of BMS-986251 Excretion Parameters in Urine. PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14
Area Under the Concentration-time Curve Over 24 Hours (One Dosing Interval) [AUC(0-24)] (Part B)
Time Frame: Part B : Days 1 and Day 14
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part B : Days 1 and Day 14
Ratio of AUC(0-24) Following Last Dose to AUC(0-24) Following First Dose [AR[AUC(0-24)]] (Part B)
Time Frame: Part B : Day 14
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part B : Day 14
Ratio of Cmax Following Last Dose to Cmax Following First Dose [AR(Cmax)] (Part B)
Time Frame: Part B : Day 14
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part B : Day 14
Pre-dose Plasma Concentration (Cpre) (Part B)
Time Frame: Part B : Days 2-14
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Part B : Days 2-14
Inhibition at Time t [I(t)] (Part B)
Time Frame: Part B : Days 16, 20, and 24
Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters
Part B : Days 16, 20, and 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Inhibition [I(Max)]
Time Frame: Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24
Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters
Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24
Time of Maximum Observed Inhibition [t(Imax)]
Time Frame: Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24
Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters
Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24
Time of Inhibition Above 50% [t(I>50%)]
Time Frame: Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24
Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters
Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24
Time of Inhibition Above 90% [t(I>90%)]
Time Frame: Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24
Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters
Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24
Pre-dose Inhibition [I(Pre)] (Part B)
Time Frame: Part B : Days 2, 4, 7, and 14
Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters
Part B : Days 2, 4, 7, and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 26, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM024-005
  • 2017-003408-38 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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