Rheumatoid ArthritisPhase 2RAjuvenateNCT02628028
A Study of LY3337641 in Rheumatoid Arthritis
A Phase 2 study testing LY3337641 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 71 sites in 13 countries.
Trial summary
The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in adults with rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- LY3337641
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 71 sitesin 13 countries
- Study dates
- 22 Aug 2016to 15 Aug 2018
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects of childbearing potential test negative for pregnancy at screening and agree not to breastfeed
- Female subjects: agree to use a reliable method of birth control from the start of screening until 28 days after the last dose of study drug or be of nonchildbearing potential
- Male subjects: agree to use a reliable method of birth control from the start of screening until 2 weeks after the last dose of study drug or have undergone vasectomy
- Have a diagnosis of RA based on the 2010 American College of Rheumatology (ACR)/European League against Rheumatism criteria
- Have at least 1 of the following:
- rheumatoid factor or anti-citrullinated peptide antibodies (ACPA) at screening OR
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- radiographs documenting bony erosions
- Have active RA, defined as:
- Part A: ≥3 swollen joints (based on 66-joint counts)
- Part B:
- ≥6 swollen joints (based on 66-joint counts)
- ≥6 tender joints (based on 68-joint counts)
- hsCRP levels greater than the upper limit of normal (ULN) OR positive for ACPA
- Part B only: Have had inadequate response, loss of response, or intolerance to at least 1 synthetic OR biologic disease-modifying antirheumatic drug (DMARD)
Who cannot join
- Have received any of the following:
- Part B only: any prior treatment with a product directly targeting Bruton's tyrosine kinase (BTK) (marketed or investigational)
- belimumab, natalizumab, or vedolizumab within 6 months prior to baseline
- B-cell-depleting agents (such as rituximab) or other cell-depleting biologics (eg, anti-cluster of differentiation 3 (CD3) antibody) within 12 months prior to screening for Part A or at any time prior to screening for Part B
- Have known hypogammaglobulinemia
- Have hepatitis C virus, hepatitis B virus or human immunodeficiency virus
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- Have active tuberculosis (TB)
- Are at high risk of infection or have recent evidence of clinically significant infection
- Have had lymphoma, leukemia, or any malignancy within the previous 5 years except for treated basal cell or squamous epithelial carcinomas of the skin
- Have received a live (attenuated) vaccine within 28 days prior to baseline or plan to receive one during the study
Trial locations and contacts
71 sites in 13 countries.
71 sites in 13 countries
United States15 sites
Innovative Research of West Florida
Clearwater, Florida, 33756
Denver Arthritis Center
Denver, Colorado, 80230
Center for Arthritis & Osteoporosis
Elizabethtown, Kentucky, 42701
Rheumatology and Immunotherapy Center
Franklin, Wisconsin, 53132
Accurate Clinical Research
League City, Texas, 77573
Jeffrey Alper MD Research
Naples, Florida, 34102
Accurate Clinical Research
Nassau Bay, Texas, 77058
Sun Coast Clinical Research, Inc
New Port Richey, Florida, 34652
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
North Charleston, South Carolina, 29406
Desert Medical Advances
Palm Desert, California, 92260
Stanford University Hospital
Palo Alto, California, 94304
Rowan Regional Medical Center
Salisbury, North Carolina, 28144
Clayton Medical Research
St Louis, Missouri, 63117
Lovelace Scientific Resources
Venice, Florida, 34292
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
Argentina13 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Buenos Aires, C1430EGF
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Ciudad Autonoma de Buenos Aire, C1015ABO
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Ciudad Autonoma de Buenos Aire, C1128AAF
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Ciudad Autonoma de Buenos Aire, C1204AAD
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Ciudad Autonoma de Buenos Aire, C1426AAL
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Ciudad Autonoma de Buenos Aire, c1440AAD
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Córdoba, X5000EDC
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Rosario, S2000CFJ
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Rosario, S2000PBJ
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San Fernando, B1646DBM
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San Juan, J5402DIL
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San Miguel de Tucumán, 4000
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San Miguel de Tucumán, T4000AXL
Japan12 sites
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Asahikawa, 070-8644
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Chiba, 275-8580
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Fukuoka, 810-8539
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Fukuoka, 810-8563
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Hokkaido, 060-0001
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Kitakyushu, 807-8556
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Nagano, 380-8582
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Ōmura, 856-8562
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Sapporo, 060-0004
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Sapporo, 060-8648
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Sasebo, 857-1195
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Sendai, 980-8574
South Korea5 sites
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Junggu, 22332
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Seoul, 04763
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Seoul, 05030
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Seoul, 06591
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Seoul, 07345
Mexico4 sites
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Colonia Roma, 6700
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Distrito Federal, 3100
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Mexicali, 21100
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Mexico City, 06700
Poland4 sites
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Elblag, 82-300
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Gdansk, 80-546
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Nadarzyn, 05-830
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Warsaw, 03-291
Italy3 sites
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Florence, 50139
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Milan, 20157
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Torino, 10154
Puerto Rico3 sites
Office: Perez-De Jesus, Amarilis
Caguas, PR, 00725
Mindful Medical Research
San Juan, PR, 00918
Latin Clinical Trial Center
Santurce, 00909
South Africa3 sites
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Pinelands, 7405
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Stellenbosch, 7600
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Umhlanga, 4319
Spain3 sites
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Alicante, 03570
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Bilbao, 48013
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Seville, 41010
Australia2 sites
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Maroochydore, 4558
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Woodville South, 5011
Austria2 sites
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Innsbruck, 6020
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Vienna, 1090
Slovakia2 sites
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Bratislava, 85101
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Zvolen, 96001
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects With Rheumatoid Arthritis: The RAjuvenate Study
The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in adults with rheumatoid arthritis (RA).
- Conditions
- Rheumatoid Arthritis
- Being tested
- LY3337641, 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.
LY3337641Drug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part A 5 mg LY3337641 | Experimental | Given once a day for 4 weeks. Receives: Drug: LY3337641 |
| Part A 10 mg LY3337641 | Experimental | Given once a day for 4 weeks. Receives: Drug: LY3337641 |
| Part A 30 mg LY3337641 | Experimental | Given once a day for 4 weeks. Receives: Drug: LY3337641 |
| Part A Placebo | Placebo comparator | Given once a day for 4 weeks. Receives: Drug: Placebo |
| Part B 5 mg LY3337641 | Experimental | Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period. Receives: Drug: LY3337641 |
| Part B 10 mg LY3337641 | Experimental | Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period. Receives: Drug: LY3337641 |
| Part B 30 mg LY3337641 | Experimental | Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period. Receives: Drug: LY3337641 |
| Part B Placebo | Placebo comparator | Given once a day for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs) or Adverse Events of Special Interest (AESIs) or Any Serious AEs (SAEs) in Part A
TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. Skin Rash was the only event that was considered an AESI. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of SAEs and other non-serious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
Measured: Up to 6 Weeks
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response in Part B
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient's Global Assessment of Arthritis Pain using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI) and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and /or participants who discontinue study or drug before analysis timepoint are deemed non-responders.
Measured: Week 12
Secondary outcomes (6)
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response in Part B
ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR50 Responder" is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria:
Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient's Global Assessment of Arthritis Pain using VAS, HAQ-DI and hsCRP. Participants with missing responses and/or participants who discontinue study or drug before analysis timepoint are deemed non-responders.
Measured: Week 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response in Part B
ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR70 Responder" is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria:
Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient's Global Assessment of Arthritis Pain using VAS, HAQ-DI and hsCRP. Participants with missing responses and/or participants who discontinue study or drug before analysis timepoint are deemed non-responders.
Measured: Week 12
Change From Baseline in the Disease Activity Score (DAS) 28-high-sensitivity C-reactive Protein (hsCRP) in Part B
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using VAS. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
Measured: Baseline, Week 12
Percentage of Participants Who Achieve Low Disease Activity Using DAS28-hsCRP in Part B
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using VAS. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
Measured: Week 12
Percentage of Participants Who Achieve Clinical Remission Using DAS28-hsCRP in Part B
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Clinical remission is defined as DAS28-hsCRP <2.6.
Measured: Week 12
Pharmacokinetics (PK): Clearance Parameter of LY3337641
Apparent total body clearance of drug after oral administration based on population PK analysis was evaluated. As prespecified per protocol, an overall population estimate of clearance is generated and data from Part A and B were combined for the analysis. The sparse data was then analyzed using population PK methods in Non linear Mixed Effects Model (NONMEM) to generate an overall population estimate of clearance.
Measured: Part A: Weeks 1, 2, and 4, Day 1 (0.5 to 2 hours postdose); Part B: Weeks 2, 4, 8, and 12, Day 1 (0.5 to 2 hours postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study start22 Aug 2016
- Primary completion25 Apr 2018
- Study completion15 Aug 2018
Why it stopped: The trial was terminated after an interim analysis of efficacy and safety data did not warrant continuation of the trial.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628028
- Sponsor's protocol ID
- 16173
- Other IDs
- I8K-MC-JPDA, 2015-003289-97, 2015
- Acronym
- RAjuvenate
- Status last verified
- Sep 2019
- First submitted
- 9 Dec 2015
- Last updated
- 9 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Genovese MC, Spindler A, Sagawa A, Park W, Dudek A, Kivitz A, Chao J, Chan LSM, Witcher J, Barchuk W, Nirula A. Safety and Efficacy of Poseltinib, Bruton's Tyrosine Kinase Inhibitor, in Patients With Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled, 2-part Phase II Study. J Rheumatol. 2021 Jul;48(7):969-976. doi: 10.3899/jrheum.200893. Epub 2020 Dec 15.
PubMed 33323529
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects With Rheumatoid Arthritis: The RAjuvenate Study
- ClinicalTrials.gov ID
- NCT02628028
- Acronym / sponsor ID
- RAjuvenate / 16173
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated after an interim analysis of efficacy and safety data did not warrant continuation of the trial.
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Posted 9 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 main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in adults with rheumatoid arthritis (RA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part A 5 mg LY3337641 | Experimental | Drug: LY3337641Given once a day for 4 weeks. |
| Part A 10 mg LY3337641 | Experimental | Drug: LY3337641Given once a day for 4 weeks. |
| Part A 30 mg LY3337641 | Experimental | Drug: LY3337641Given once a day for 4 weeks. |
| Part A Placebo | Placebo comparator | Drug: PlaceboGiven once a day for 4 weeks. |
| Part B 5 mg LY3337641 | Experimental | Drug: LY3337641Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period. |
| Part B 10 mg LY3337641 | Experimental | Drug: LY3337641Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period. |
| Part B 30 mg LY3337641 | Experimental | Drug: LY3337641Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period. |
| Part B Placebo | Placebo comparator | Drug: PlaceboGiven once a day for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female subjects of childbearing potential test negative for pregnancy at screening and agree not to breastfeed
- Female subjects: agree to use a reliable method of birth control from the start of screening until 28 days after the last dose of study drug or be of nonchildbearing potential
- Male subjects: agree to use a reliable method of birth control from the start of screening until 2 weeks after the last dose of study drug or have undergone vasectomy
- Have a diagnosis of RA based on the 2010 American College of Rheumatology (ACR)/European League against Rheumatism criteria
- Have at least 1 of the following:
Key exclusion criteria (10 listed)
- Have received any of the following:
- Have known hypogammaglobulinemia
- Have hepatitis C virus, hepatitis B virus or human immunodeficiency virus
- Have active tuberculosis (TB)
- Are at high risk of infection or have recent evidence of clinically significant infection
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 |
|---|---|---|
| LY3337641Administered orally | Drug | Part A 10 mg LY3337641, Part A 30 mg LY3337641, Part A 5 mg LY3337641, Part B 10 mg LY3337641, Part B 30 mg LY3337641, Part B 5 mg LY3337641 |
| PlaceboAdministered orally | Drug | Part A Placebo, Part B Placebo |
Primary outcome
Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs) or Adverse Events of Special Interest (AESIs) or Any Serious AEs (SAEs) in Part A
Time frame: Up to 6 Weeks
TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. Skin Rash was the only event that was considered an AESI. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of SAEs and other non-serious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response in Part B
Time frame: Week 12
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient's Global Assessment of Arthritis Pain using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI) and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and /or participants who discontinue study or drug before analysis timepoint are deemed non-responders.
6 secondary outcomes
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response in Part B
Time frame: Week 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response in Part B
Time frame: Week 12
Change From Baseline in the Disease Activity Score (DAS) 28-high-sensitivity C-reactive Protein (hsCRP) in Part B
Time frame: Baseline, Week 12
Percentage of Participants Who Achieve Low Disease Activity Using DAS28-hsCRP in Part B
Time frame: Week 12
Percentage of Participants Who Achieve Clinical Remission Using DAS28-hsCRP in Part B
Time frame: Week 12
Pharmacokinetics (PK): Clearance Parameter of LY3337641
Time frame: Part A: Weeks 1, 2, and 4, Day 1 (0.5 to 2 hours postdose); Part B: Weeks 2, 4, 8, and 12, Day 1 (0.5 to 2 hours postdose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33323529Genovese MC, Spindler A, Sagawa A, Park W, Dudek A, Kivitz A, Chao J, Chan LSM, Witcher J, Barchuk W, Nirula A. Safety and Efficacy of Poseltinib, Bruton's Tyrosine Kinase Inhibitor, in Patients With Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled, 2-part Phase II Study. J Rheumatol. 2021 Jul;48(7):969-976. doi: 10.3899/jrheum.200893. Epub 2020 Dec 15.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
71 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY3337641 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 71 sites in 13 countries.
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 14 inclusion and 10 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 9 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 71 sites in United States, Argentina, Japan, South Korea, Mexico and 8 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 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 With One or More Treatment-Emergent Adverse Events (TEAEs) or Adverse Events of Special Interest (AESIs) or Any Serious AEs (SAEs) in Part A (time frame: Up to 6 Weeks). 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?
On the ClinicalTrials.gov record for NCT02628028, which also lists 1 linked publication.
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 9 Oct 2019.