Rheumatoid ArthritisPhase 2NCT02151474
INCB047986 in Rheumatoid Arthritis
A Phase 2 study testing INCB047986 in people with Rheumatoid Arthritis, run by Incyte Corporation at 9 sites in United States.
Trial summary
The purpose of this study is to explore the safety, tolerability and efficacy of INCB047986, in subjects with moderate to severe rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- INCB047986
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2014to Aug 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 to 75 years, inclusive.
- Body mass index between 18 and 40 kg/m^2, inclusive.
- Subjects must have a diagnosis of rheumatoid arthritis (RA) of at least 6 months' duration at the time of screening and must satisfy the ACR/European League Against Rheumatism (EULAR) 2010 Classification Criteria (Appendix B).
- Subjects must have active moderate to severe RA as determined by the following:
- ≥ 6 tender joints (28 joint count),
- ≥ 4 swollen joints (28 joint count), and
- CRP level ≥ 6 mg/L.
- Subjects must have a negative tuberculosis (TB) test (QuantiFERON®-TB Gold test or purified protein derivative (PPD)) at screening.
Who cannot join
- Current or recent history of severe and/or progressive uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
- Current or recent history (< 30 days before screening and/or < 45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection.
- Onset of RA before the age of 16 years.
- History of known or currently suspected inflammatory disease other than RA
- Current regimen of prednisone or equivalent with an average daily dose of > 10 mg or having been treated with a stable daily dose ≤ 10 mg for < 6 weeks.
- Previous treatment with at Janus kinase (JAK) inhibitor.
- Significant impairment of bone marrow function present at screening
- Receipt of any live vaccine within 2 months before screening or anticipated need for a live vaccine within the 2 months after last dose of study drug.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Austin, Texas
Study site
Charlotte, North Carolina
Study site
DeBary, Florida
Study site
Frederick, Maryland
Study site
Oklahoma City, Oklahoma
Study site
Orange, California
Study site
Palm Harbor, Florida
Study site
Tampa, Florida
Study site
The Woodlands, Texas
About this study
Official title: A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of INCB047986 in Subjects With Active Rheumatoid Arthritis
The purpose of this study is to explore the safety, tolerability and efficacy of INCB047986, in subjects with moderate to severe rheumatoid arthritis.
Read the detailed description
This will be a double-blind, placebo-controlled study with 4 parallel treatment groups. Subjects will be screened for up to 28 days before study drug administration to ensure that all eligibility criteria are met. On Day 1, subjects will be randomized to 1 of 4 dose groups of 15 subjects each (INCB047986 4 mg, 8 mg, 12 mg, or placebo QD). Study drug will be self administered on Days 1 through 28. A follow-up telephone call to the subject to assess safety will occur at Day 42. A final safety and efficacy evaluation will be performed at the Day 58 visit.
- Conditions
- Rheumatoid Arthritis
- Being tested
- INCB047986, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB047986Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| INCB047986 4 mg QD | Experimental | INCB047986 4 mg will be orally self-administered once daily (QD) for 28 days. Receives: Drug: INCB047986 |
| INCB047986 8 mg QD | Experimental | INCB047986 8 mg will be orally self-administered once daily (QD) for 28 days. Receives: Drug: INCB047986 |
| INCB047986 12 mg QD | Experimental | INCB047986 12 mg will be orally self-administered once daily (QD) for 28 days. Receives: Drug: INCB047986 |
| INCB047986 placebo QD | Experimental | INCB047986 placebo will be orally self-administered once daily (QD) for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with adverse events, changes in electrocardiograms (ECGs), vital signs, physical examinations, or clinical laboratory evaluations
Measured: Baseline through day 28
Percentage of Participants Achieving American College of Rheumatology, 20% Improvement (ACR20)
Measured: Baseline through Day 28
Secondary outcomes (9)
Percentage of subjects achieving ACR20 at each visit assessed.
Measured: Baseline, Day 8, 15 and Follow-Up
Percentage of subjects achieving American College of Rheumatology, 50% improvement (ACR50) at each visit assessed.
Measured: Baseline, Day 8, 15 28 and Follow-Up
Percentage of subjects achieving American College of Rheumatology, 70% improvement (ACR70) at each visit assessed.
Measured: Baseline, Day 8, 15 28 and Follow-Up
Change in Disease Activity Score - 28-joint count (DAS28) C-reactive protein (CRP) at the Day 28 visit.
Measured: Day 28
Change in DAS28 erythrocyte sedimentation rate (ESR) at the Day 28 visit.
Measured: Day 28
Percentage of subjects achieving a DAS28 of ≤ 3.2 at the Day 28 visit.
Measured: Day 28
Percentage of subjects achieving a DAS28 of ≤ 2.6 at the Day 28 visit.
Measured: Day 28
Change in individual American College of Rheumatology (ACR) assessments.
Measured: Day 28
Preliminary pharmacokinetic (PK)
Measured: Evaluated after 15 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Levy, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151474
- Sponsor's protocol ID
- INCB 47986-202
- Status last verified
- Feb 2015
- First submitted
- 28 May 2014
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of INCB047986 in Subjects With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02151474
- Acronym / sponsor ID
- INCB 47986-202
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 30 May 2014 (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 explore the safety, tolerability and efficacy of INCB047986, in subjects with moderate to severe rheumatoid arthritis.
Detailed description
This will be a double-blind, placebo-controlled study with 4 parallel treatment groups. Subjects will be screened for up to 28 days before study drug administration to ensure that all eligibility criteria are met. On Day 1, subjects will be randomized to 1 of 4 dose groups of 15 subjects each (INCB047986 4 mg, 8 mg, 12 mg, or placebo QD). Study drug will be self administered on Days 1 through 28. A follow-up telephone call to the subject to assess safety will occur at Day 42. A final safety and efficacy evaluation will be performed at the Day 58 visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| INCB047986 4 mg QD | Experimental | Drug: INCB047986INCB047986 4 mg will be orally self-administered once daily (QD) for 28 days. |
| INCB047986 8 mg QD | Experimental | Drug: INCB047986INCB047986 8 mg will be orally self-administered once daily (QD) for 28 days. |
| INCB047986 12 mg QD | Experimental | Drug: INCB047986INCB047986 12 mg will be orally self-administered once daily (QD) for 28 days. |
| INCB047986 placebo QD | Experimental | Drug: PlaceboINCB047986 placebo will be orally self-administered once daily (QD) for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women aged 18 to 75 years, inclusive.
- Body mass index between 18 and 40 kg/m^2, inclusive.
- Subjects must have a diagnosis of rheumatoid arthritis (RA) of at least 6 months' duration at the time of screening and must satisfy the ACR/European League Against Rheumatism (EULAR) 2010 Classification Criteria (Appendix B).
- Subjects must have active moderate to severe RA as determined by the following:
- Subjects must have a negative tuberculosis (TB) test (QuantiFERON®-TB Gold test or purified protein derivative (PPD)) at screening.
Key exclusion criteria (8 listed)
- Current or recent history of severe and/or progressive uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
- Current or recent history (< 30 days before screening and/or < 45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection.
- Onset of RA before the age of 16 years.
- History of known or currently suspected inflammatory disease other than RA
- Current regimen of prednisone or equivalent with an average daily dose of > 10 mg or having been treated with a stable daily dose ≤ 10 mg for < 6 weeks.
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 |
|---|---|---|
| INCB047986 | Drug | INCB047986 12 mg QD, INCB047986 4 mg QD, INCB047986 8 mg QD |
| Placebo | Drug | INCB047986 placebo QD |
Primary outcome
Percentage of participants with adverse events, changes in electrocardiograms (ECGs), vital signs, physical examinations, or clinical laboratory evaluations
Time frame: Baseline through day 28
Percentage of Participants Achieving American College of Rheumatology, 20% Improvement (ACR20)
Time frame: Baseline through Day 28
9 secondary outcomes
Percentage of subjects achieving ACR20 at each visit assessed.
Time frame: Baseline, Day 8, 15 and Follow-Up
Percentage of subjects achieving American College of Rheumatology, 50% improvement (ACR50) at each visit assessed.
Time frame: Baseline, Day 8, 15 28 and Follow-Up
Percentage of subjects achieving American College of Rheumatology, 70% improvement (ACR70) at each visit assessed.
Time frame: Baseline, Day 8, 15 28 and Follow-Up
Change in Disease Activity Score - 28-joint count (DAS28) C-reactive protein (CRP) at the Day 28 visit.
Time frame: Day 28
Change in DAS28 erythrocyte sedimentation rate (ESR) at the Day 28 visit.
Time frame: Day 28
Percentage of subjects achieving a DAS28 of ≤ 3.2 at the Day 28 visit.
Time frame: Day 28
Percentage of subjects achieving a DAS28 of ≤ 2.6 at the Day 28 visit.
Time frame: Day 28
Change in individual American College of Rheumatology (ACR) assessments.
Time frame: Day 28
Preliminary pharmacokinetic (PK)
Time frame: Evaluated after 15 days of treatment
Results and safety
The study was stopped early (reason given: Business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
Related trials for Rheumatoid Arthritis
RecruitingPhase 1
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Not yet recruiting
Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis
Rheumatic Arthritis
RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
A Study of AZD0120 in Autoimmune Diseases
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
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.
Richard Levy, MD study director
Incyte Corporation
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INCB047986 in people with Rheumatoid Arthritis, run by Incyte Corporation at 9 sites in United States.
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 8 inclusion and 8 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 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 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?
The study was stopped early (reason given: Business decision.). Results are not available in the source record.
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?
Percentage of participants with adverse events, changes in electrocardiograms (ECGs), vital signs, physical examinations, or clinical laboratory evaluations (time frame: Baseline through day 28). The study lists 2 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 23 Feb 2015.