PsoriasisPhase 1NCT02763969
Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis
A Phase 1 study testing BMS-986202, Interferon alpha-2a recombinant and Famotidine in people with Psoriasis, run by Bristol-Myers Squibb at 2 sites in Australia.
Trial summary
The purpose of this study is to establish if BMS-986202 is safe and effective at treating autoimmune diseases such as psoriasis. BMS-986202 which has shown some promise in preclinical studies for inhibiting autoimmune conditions such as psoriasis. This study will be the first time this drug is given to humans. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- BMS-986202, Interferon alpha-2a recombinant and Famotidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 357 participants
- Where
- 2 sitesAustralia
- Study dates
- 18 May 2016to 15 Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy Male and Female participants
- 18 to 50 years of age (Parts A-D)
- 18 to 70 years of age (Part E)
- Diagnosed with plaque psoriasis (Part E)
Who cannot join
- Participants that had recent infections
- Participants with Low Blood Pressure
- Participants with any heart related problems
- Participants with cancer
- Participants with any other major medical illness
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Local Institution
Melbourne, Victoria, 3004
Local Institution
Melbourne, 3004
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986202 in Healthy Subjects and to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of BMS-986202 in Subjects With Moderate to Severe Psoriasis
The purpose of this study is to establish if BMS-986202 is safe and effective at treating autoimmune diseases such as psoriasis. BMS-986202 which has shown some promise in preclinical studies for inhibiting autoimmune conditions such as psoriasis. This study will be the first time this drug is given to humans.
- Conditions
- Psoriasis
- Being tested
- BMS-986202, Placebo, Interferon alpha-2a recombinant, Famotidine, Ustekinumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986202Drug
PlaceboDrug
Interferon alpha-2a recombinantDrug
FamotidineDrug
UstekinumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Ascending Dose | Experimental | BMS-986202 or Placebo specified dose on specified days Receives: Drug: BMS-986202; Drug: Placebo |
| Part B: Multiple Ascending Dose | Experimental | BMS-986202 or Placebo + Interferon alpha-2a recombinant specified dose on specified days Receives: Drug: BMS-986202; Drug: Placebo; Drug: Interferon alpha-2a recombinant |
| Part C: Multiple Ascending Dose-Japanese descent | Experimental | BMS-986202 or Placebo specified dose on specified days in patients of Japanese descent Receives: Drug: BMS-986202; Drug: Placebo |
| Part D: Relative Bioavailability | Experimental | BMS-986202 (Liquid) or BMS-986202 (Capsule) + Famotidine specified dose on specified days Receives: Drug: BMS-986202; Drug: Famotidine |
| Part E: Proof of Mechanism | Experimental | BMS-986202 or Placebo + Ustekinumab specified dose on specified days Receives: Drug: BMS-986202; Drug: Placebo; Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of a single oral dose of BMS-986202 based on number of incidence of AEs, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Measured: 4 weeks after the start of treatment
Safety of a multiple oral dose of BMS-986202 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Measured: 4 weeks after the start of treatment
Change from baseline in the psoriasis area
Measured: 4 weeks after the start of treatment
Severity index (PASI) score
Measured: 4 weeks after the start of treatment
Secondary outcomes (5)
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D)
Measured: Approximately 3 months
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D)
The interval from the beginning of the P wave to the beginning of the QRS complex (PR interval)
Measured: Approximately 3 months
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D)
The interval from the beginning of the Q wave and the end of the S wave (QRS interval)
Measured: Approximately 3 months
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D)
The interval from the beginning of the Q wave to the end of the T wave (QT interval).
The QT interval corrected for heart rate (QTc interval)
Measured: Approximately 3 months
Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E)
Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E) based on number of incidence of adverse events(AEs), serious adverse events(SAEs), AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Measured: Approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start18 May 2016
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 357 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
- NCT02763969
- Sponsor's protocol ID
- IM016-006
- Status last verified
- Jul 2017
- First submitted
- 4 May 2016
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986202 in Healthy Subjects and to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of BMS-986202 in Subjects With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT02763969
- Acronym / sponsor ID
- IM016-006
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 May 2016 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
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 establish if BMS-986202 is safe and effective at treating autoimmune diseases such as psoriasis. BMS-986202 which has shown some promise in preclinical studies for inhibiting autoimmune conditions such as psoriasis. This study will be the first time this drug is given to humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Ascending Dose | Experimental | Drug: BMS-986202, Drug: PlaceboBMS-986202 or Placebo specified dose on specified days |
| Part B: Multiple Ascending Dose | Experimental | Drug: BMS-986202, Drug: Placebo, Drug: Interferon alpha-2a recombinantBMS-986202 or Placebo + Interferon alpha-2a recombinant specified dose on specified days |
| Part C: Multiple Ascending Dose-Japanese descent | Experimental | Drug: BMS-986202, Drug: PlaceboBMS-986202 or Placebo specified dose on specified days in patients of Japanese descent |
| Part D: Relative Bioavailability | Experimental | Drug: BMS-986202, Drug: FamotidineBMS-986202 (Liquid) or BMS-986202 (Capsule) + Famotidine specified dose on specified days |
| Part E: Proof of Mechanism | Experimental | Drug: BMS-986202, Drug: Placebo, Drug: UstekinumabBMS-986202 or Placebo + Ustekinumab specified dose on specified days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy Male and Female participants
- 18 to 50 years of age (Parts A-D)
- 18 to 70 years of age (Part E)
- Diagnosed with plaque psoriasis (Part E)
Key exclusion criteria (6 listed)
- Participants that had recent infections
- Participants with Low Blood Pressure
- Participants with any heart related problems
- Participants with cancer
- Participants with any other major medical illness
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-986202 | Drug | Part A: Single Ascending Dose, Part B: Multiple Ascending Dose, Part C: Multiple Ascending Dose-Japanese descent, Part D: Relative Bioavailability, Part E: Proof of Mechanism |
| Placebo | Drug | Part A: Single Ascending Dose, Part B: Multiple Ascending Dose, Part C: Multiple Ascending Dose-Japanese descent, Part E: Proof of Mechanism |
| Interferon alpha-2a recombinant | Drug | Part B: Multiple Ascending Dose |
| Famotidine | Drug | Part D: Relative Bioavailability |
| Ustekinumab | Drug | Part E: Proof of Mechanism |
Primary outcome
Safety of a single oral dose of BMS-986202 based on number of incidence of AEs, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Time frame: 4 weeks after the start of treatment
Safety of a multiple oral dose of BMS-986202 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Time frame: 4 weeks after the start of treatment
Change from baseline in the psoriasis area
Time frame: 4 weeks after the start of treatment
Severity index (PASI) score
Time frame: 4 weeks after the start of treatment
5 secondary outcomes
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D)
Time frame: Approximately 3 months
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Time frame: Approximately 3 months
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Time frame: Approximately 3 months
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Time frame: Approximately 3 months
Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E)
Time frame: Approximately 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986202, Interferon alpha-2a recombinant and Famotidine in people with Psoriasis, run by Bristol-Myers Squibb at 2 sites in Australia.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of a single oral dose of BMS-986202 based on number of incidence of AEs, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations (time frame: 4 weeks after the start of treatment). The study lists 4 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 3 Aug 2017.