Rheumatoid ArthritisPhase 1/2NCT03329885
A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis
A Phase 1/2 study testing BMS-986251 in people with Rheumatoid Arthritis and Psoriasis, run by Bristol-Myers Squibb at 1 site in Netherlands.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Psoriasis, Ankylosing Spondylitis
- What is being tested?
- BMS-986251
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Nov 2017to 26 Jun 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Males and females, ages 18 to 70 years, inclusive, at screening
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- 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:
- Affected body surface area (BSA) of ≥10%
- Psoriasis Area and Severity Index (PASI) ≥12
- Physician Global Assessment (PGA; 6-point scale) ≥3
Who cannot join
- 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
- Previous participation in the current study
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Rheumatoid Arthritis, Psoriasis, Ankylosing Spondylitis, Inflammatory Bowel Diseases, Nonalcoholic Steatohepatitis
- Being tested
- BMS-986251, Placebo
- Medical subject headings
- Arthritis, Rheumatoid, Psoriasis, Spondylitis, Ankylosing, Inflammatory Bowel Diseases, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986251Drug
Escalating oral dose
PlaceboOther
Escalating oral dose
| Study group | Role | What they receive |
|---|---|---|
| Part A Single Ascending Dose (SAD) in Healthy Patients | Experimental | Healthy patient will receive single escalating oral doses of BMS-986251 or placebo Receives: Drug: BMS-986251; Other: Placebo |
| Part B Multiple Ascending Dose (MAD) in Healthy Patients | Experimental | Healthy patients will receive daily escalating oral doses of BMS-986251 or placebo Receives: Drug: BMS-986251; Other: Placebo |
| Part C Multiple Dosing in Psoriasis Patients | Experimental | Psoriasis patients will receive daily escalating oral doses of BMS-986251 or placebo Receives: Drug: BMS-986251; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Experienced the Following: Serious Adverse Events (SAEs), Death or an Adverse Event (AE) Leading to Study Discontinuation
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
Measured: 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
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.
Measured: 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
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
Measured: 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
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
Measured: Part A: Days 2, 4, 7 and 11; Part B: Days 3, 7, 10, 14, 16, 24
Maximum Observed Plasma Concentration (Cmax)
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Measured: 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)
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Measured: 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)]
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Measured: 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)
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Measured: Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11
Terminal Elimination Half-life, Calculated as 0.693/Kel [t(1/2)]
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Measured: 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
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Measured: Part A: Day 1, Part B: Day 14
Apparent Volume of Distribution at Terminal Phase [V(z)/F]
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Measured: 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)]
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
Measured: Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14
Amount Excreted Unchanged in Urine (% of Dose) [Fe(Urine)%]
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
Measured: Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14
Renal Clearance [CL(R)]
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
Measured: 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)
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Measured: 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)
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Measured: Part B : Day 14
Ratio of Cmax Following Last Dose to Cmax Following First Dose [AR(Cmax)] (Part B)
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Measured: Part B : Day 14
Pre-dose Plasma Concentration (Cpre) (Part B)
PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified
Measured: Part B : Days 2-14
Inhibition at Time t [I(t)] (Part B)
Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters
Measured: Part B : Days 16, 20, and 24
Secondary outcomes (5)
Maximum Observed Inhibition [I(Max)]
Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters
Measured: Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24
Time of Maximum Observed Inhibition [t(Imax)]
Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters
Measured: 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%)]
Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters
Measured: 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%)]
Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters
Measured: Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24
Pre-dose Inhibition [I(Pre)] (Part B)
Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters
Measured: Part B : Days 2, 4, 7, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start2 Nov 2017
- Primary completion26 Jun 2018
- Study completion26 Jun 2018
Why it stopped: Adverse change in the risk/benefit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329885
- Sponsor's protocol ID
- IM024-005
- Other IDs
- 2017-003408-38, 2017
- Status last verified
- Sep 2019
- First submitted
- 31 Oct 2017
- Last updated
- 21 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03329885
- Acronym / sponsor ID
- IM024-005
- Conditions
- Rheumatoid Arthritis, Psoriasis, Ankylosing Spondylitis, Inflammatory Bowel Diseases, Nonalcoholic Steatohepatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adverse change in the risk/benefit
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 21 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A Single Ascending Dose (SAD) in Healthy Patients | Experimental | Drug: BMS-986251, Other: PlaceboHealthy patient will receive single escalating oral doses of BMS-986251 or placebo |
| Part B Multiple Ascending Dose (MAD) in Healthy Patients | Experimental | Drug: BMS-986251, Other: PlaceboHealthy patients will receive daily escalating oral doses of BMS-986251 or placebo |
| Part C Multiple Dosing in Psoriasis Patients | Experimental | Drug: BMS-986251, Other: PlaceboPsoriasis patients will receive daily escalating oral doses of BMS-986251 or placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986251Escalating oral dose | Drug | Part A Single Ascending Dose (SAD) in Healthy Patients, Part B Multiple Ascending Dose (MAD) in Healthy Patients, Part C Multiple Dosing in Psoriasis Patients |
| PlaceboEscalating oral dose | Other | Part A Single Ascending Dose (SAD) in Healthy Patients, Part B Multiple Ascending Dose (MAD) in Healthy Patients, Part C Multiple Dosing in Psoriasis Patients |
Primary outcome
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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
5 secondary outcomes
Maximum Observed Inhibition [I(Max)]
Time frame: 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
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
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
Pre-dose Inhibition [I(Pre)] (Part B)
Time frame: Part B : Days 2, 4, 7, and 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986251 in people with Rheumatoid Arthritis and Psoriasis, run by Bristol-Myers Squibb at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.