A Phase 2 interventional study of LY3337641 and Placebo in Rheumatoid Arthritis, sponsored by Eli Lilly and Company. Terminated at 71 sites in 13 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-10-09.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in adults with rheumatoid arthritis (RA).
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 286 is above the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have at least 1 of the following:
Have active RA, defined as:
Exclusion Criteria:
Have received any of the following:
Given once a day for 4 weeks.
Drug: LY3337641
Given once a day for 4 weeks.
Drug: LY3337641
Given once a day for 4 weeks.
Drug: LY3337641
Given once a day for 4 weeks.
Drug: Placebo
Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.
Drug: LY3337641
Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.
Drug: LY3337641
Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.
Drug: LY3337641
Given once a day for 12 weeks.
Drug: Placebo
Administered orally
Administered orally
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.
Time frame: 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.
Time frame: Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
| Milestone | Part A: Placebo | Part A: 5 mg LY3337641 | Part A: 10 mg LY3337641 | Part A: 30 mg LY3337641 | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 |
|---|---|---|---|---|---|---|---|---|
| Started | 9 | 9 | 10 | 8 | 62 | 63 | 62 | 63 |
| Received at least 1dose of study drug | 9 | 9 | 10 | 8 | 62 | 63 | 62 | 63 |
| Completed | 9 | 9 | 9 | 8 | 46 | 49 | 46 | 48 |
| Not completed | 0 | 0 | 1 | 0 | 16 | 14 | 16 | 15 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 | 2 | 4 | 1 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 2 | 1 | 3 | 2 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 0 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 0 | 7 | 6 | 7 | 7 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Site terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 2 | 1 | 2 | 4 |
| Milestone | Part A: Placebo | Part A: 5 mg LY3337641 | Part A: 10 mg LY3337641 | Part A: 30 mg LY3337641 | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 61 | 58 | 61 |
| Placebo re-randomized in lte | 0 | 0 | 0 | 0 | 0 | 14 | 14 | 14 |
| Completed | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 60 | 58 | 61 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 52 | 51 | 51 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 2 | 3 | 3 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 0 | 3 | 4 | 3 |
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.
| Participants | Part A: Placebo | Part A: 5 mg LY3337641 | Part A: 10 mg LY3337641 | Part A: 30 mg LY3337641 |
|---|---|---|---|---|
| TEAEs | 3 | 1 | 6 | 2 |
| AESIs | 0 | 0 | 0 | 0 |
| SAEs | 0 | 0 | 0 | 0 |
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.
| Percentage of Participants | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 |
|---|---|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response in Part B | 48.1 (34.8 to 61.5) | 55.4 (42.3 to 68.4) | 44.2 (30.7 to 57.7) | 50.9 (37.7 to 64.1) |
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.
| Percentage of Participants | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 |
|---|---|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response in Part B | 27.8 (15.8 to 39.7) | 25.0 (13.7 to 36.3) | 15.4 (5.6 to 25.2) | 29.1 (17.1 to 41.1) |
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.
| Percentage of Participants | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 |
|---|---|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response in Part B | 16.7 (6.7 to 26.6) | 8.9 (1.5 to 16.4) | 1.9 (0.0 to 5.7) | 16.4 (6.6 to 26.1) |
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.
| units on a scale | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 |
|---|---|---|---|---|
| Change From Baseline in the Disease Activity Score (DAS) 28-high-sensitivity C-reactive Protein (hsCRP) in Part B | -1.62 ± 1.447 | -1.55 ± 1.182 | -1.24 ± 1.146 | -1.80 ± 1.453 |
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.
| Percentage of Participants | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 |
|---|---|---|---|---|
| Percentage of Participants Who Achieve Low Disease Activity Using DAS28-hsCRP in Part B | 27.8 (15.8 to 39.7) | 32.1 (19.9 to 44.4) | 21.2 (10.1 to 32.3) | 29.1 (17.1 to 41.1) |
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.
| Percentage of Participants | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 |
|---|---|---|---|---|
| Percentage of Participants Who Achieve Clinical Remission Using DAS28-hsCRP in Part B | 20.4 (9.6 to 31.1) | 19.6 (9.2 to 30.0) | 7.7 (0.4 to 14.9) | 25.5 (13.9 to 37.0) |
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.
| Liter per hour (L/hr) | LY3337641 |
|---|---|
| Pharmacokinetics (PK): Clearance Parameter of LY3337641 | 29.1 ± 5.9 |
Collected over Up to 88 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A: Placebo | 0/9 (0%) | 0/9 (0%) | 3/9 (33.3%) |
| Part A: 5 mg LY3337641 | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) |
| Part A: 10 mg LY3337641 | 0/10 (0%) | 0/10 (0%) | 6/10 (60%) |
| Part A: 30 mg LY3337641 | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| Part B: Placebo | 0/62 (0%) | 2/62 (3.2%) | 7/62 (11.3%) |
| Part B: 5 mg LY3337641 | 0/63 (0%) | 0/63 (0%) | 10/63 (15.9%) |
| Part B: 10 mg LY3337641 | 0/62 (0%) | 0/62 (0%) | 12/62 (19.4%) |
| Part B: 30 mg LY3337641 | 1/63 (1.6%) | 3/63 (4.8%) | 19/63 (30.2%) |
| Long-Term Extension: 5 mg LY3337641 | 0/61 (0%) | 1/61 (1.6%) | 11/61 (18%) |
| Long-Term Extension: 10 mg LY3337641 | 0/58 (0%) | 3/58 (5.2%) | 12/58 (20.7%) |
| Long-Term Extension: 30 mg LY3337641 | 0/61 (0%) | 1/61 (1.6%) | 10/61 (16.4%) |
| Event | Part A: Placebo | Part A: 5 mg LY3337641 | Part A: 10 mg LY3337641 | Part A: 30 mg LY3337641 | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 | Long-Term Extension: 5 mg LY3337641 | Long-Term Extension: 10 mg LY3337641 | Long-Term Extension: 30 mg LY3337641 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ankle fractureInjury, poisoning and procedural complications | 0/9 | 0/9 | 0/10 | 0/8 | 0/62 | 0/63 | 0/62 | 0/63 | 0/61 | 1/58 | 0/61 |
| Hand fractureInjury, poisoning and procedural complications | 0/9 | 0/9 | 0/10 | 0/8 | 0/62 | 0/63 | 0/62 | 0/63 | 0/61 | 1/58 | 0/61 |
| Patella fractureInjury, poisoning and procedural complications | 0/9 | 0/9 | 0/10 | 0/8 | 0/62 | 0/63 | 0/62 | 0/63 | 0/61 | 1/58 | 0/61 |
| Pubis fractureInjury, poisoning and procedural complications | 0/9 | 0/9 | 0/10 | 0/8 | 0/62 | 0/63 | 0/62 | 0/63 | 0/61 | 1/58 | 0/61 |
| Wrist fractureInjury, poisoning and procedural complications | 0/9 | 0/9 | 0/10 | 0/8 | 0/62 | 0/63 | 0/62 | 0/63 | 0/61 | 1/58 | 0/61 |
| NephrolithiasisRenal and urinary disorders | 0/9 | 0/9 | 0/10 | 0/8 | 0/62 | 0/63 | 0/62 | 0/63 | 0/61 | 1/58 | 0/61 |
| PneumoniaInfections and infestations | 0/9 | 0/9 | 0/10 | 0/8 | 0/62 | 0/63 | 0/62 | 0/63 | 0/61 | 0/58 | 1/61 |
| Alanine aminotransferase increasedInvestigations | 0/9 | 0/9 | 0/10 | 0/8 | 0/62 | 0/63 | 0/62 | 0/63 | 1/61 | 0/58 | 0/61 |
| Cholecystitis acuteHepatobiliary disorders | 0/9 | 0/9 | 0/10 | 0/8 | 1/62 | 0/63 | 0/62 | 0/63 | 0/61 | 0/58 | 0/61 |
| Joint dislocationInjury, poisoning and procedural complications | 0/9 | 0/9 | 0/10 | 0/8 | 1/62 | 0/63 | 0/62 | 0/63 | 0/61 | 0/58 | 0/61 |
| Event | Part A: Placebo | Part A: 5 mg LY3337641 | Part A: 10 mg LY3337641 | Part A: 30 mg LY3337641 | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 | Long-Term Extension: 5 mg LY3337641 | Long-Term Extension: 10 mg LY3337641 | Long-Term Extension: 30 mg LY3337641 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| HeadacheNervous system disorders | 0/9 | 0/9 | 2/10 | 1/8 | 0/62 | 1/63 | 1/62 | 1/63 | 0/61 | 0/58 | 0/61 |
| ConstipationGastrointestinal disorders | 0/9 | 0/9 | 0/10 | 1/8 | 0/62 | 0/63 | 1/62 | 0/63 | 0/61 | 0/58 | 0/61 |
| BronchitisInfections and infestations | 0/9 | 0/9 | 0/10 | 1/8 | 0/62 | 0/63 | 0/62 | 2/63 | 1/61 | 3/58 | 1/61 |
| Benign prostatic hyperplasiaReproductive system and breast disorders | 0/1 | 0/1 | 0/1 | 0/3 | 1/8 | 0/10 | 0/6 | 0/10 | 0/9 | 0/4 | 0/10 |
| DiarrhoeaGastrointestinal disorders | 1/9 | 0/9 | 0/10 | 0/8 | 0/62 | 1/63 | 0/62 | 2/63 | 0/61 | 0/58 | 0/61 |
| Dry mouthGastrointestinal disorders | 0/9 | 1/9 | 0/10 | 0/8 | 0/62 | 0/63 | 0/62 | 0/63 | 0/61 | 0/58 | 0/61 |
| PharyngitisInfections and infestations | 1/9 | 0/9 | 0/10 | 0/8 | 2/62 | 0/63 | 1/62 | 3/63 | 0/61 | 2/58 | 1/61 |
| SinusitisInfections and infestations | 1/9 | 0/9 | 0/10 | 0/8 | 0/62 | 1/63 | 1/62 | 1/63 | 0/61 | 2/58 | 2/61 |
| HypokalaemiaMetabolism and nutrition disorders | 1/9 | 0/9 | 0/10 | 0/8 | 0/62 | 0/63 | 0/62 | 2/63 | 0/61 | 1/58 | 0/61 |
| OsteopeniaMusculoskeletal and connective tissue disorders | 0/9 | 1/9 | 0/10 | 0/8 | 0/62 | 0/63 | 0/62 | 0/63 | 0/61 | 0/58 | 0/61 |
All randomized participants who received at least 1 dose of the study drug.
| Age, Continuous(years) | Part A: Placebo | Part A: 5 mg LY3337641 | Part A: 10 mg LY3337641 | Part A: 30 mg LY3337641 | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 54.3 ± 11.43 | 54.0 ± 11.75 | 56.9 ± 6.44 | 51.9 ± 5.72 | 50.5 ± 8.75 | 50.1 ± 9.20 | 51.7 ± 9.36 | 51.9 ± 8.91 | 51.5 ± 9.09 |
| Sex: Female, Male(Participants) | Part A: Placebo | Part A: 5 mg LY3337641 | Part A: 10 mg LY3337641 | Part A: 30 mg LY3337641 | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 8 | 8 | 9 | 5 | 54 | 53 | 56 | 53 | 246 |
| Male | 1 | 1 | 1 | 3 | 8 | 10 | 6 | 10 | 40 |
| Ethnicity (NIH/OMB)(Participants) | Part A: Placebo | Part A: 5 mg LY3337641 | Part A: 10 mg LY3337641 | Part A: 30 mg LY3337641 | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 4 | 3 | 3 | 2 | 34 | 26 | 23 | 21 | 116 |
| Not Hispanic or Latino | 5 | 6 | 7 | 6 | 24 | 29 | 26 | 23 | 126 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 4 | 8 | 13 | 19 | 44 |
| Race (NIH/OMB)(Participants) | Part A: Placebo | Part A: 5 mg LY3337641 | Part A: 10 mg LY3337641 | Part A: 30 mg LY3337641 | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 6 |
| Asian | 0 | 0 | 0 | 0 | 7 | 14 | 9 | 10 | 40 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 0 | 1 | 1 | 2 | 2 | 2 | 10 |
| White | 6 | 7 | 9 | 7 | 53 | 46 | 50 | 51 | 229 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Part A: Placebo | Part A: 5 mg LY3337641 | Part A: 10 mg LY3337641 | Part A: 30 mg LY3337641 | Part B: Placebo | Part B: 5 mg LY3337641 | Part B: 10 mg LY3337641 | Part B: 30 mg LY3337641 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Puerto Rico | 0 | 0 | 0 | 0 | 4 | 2 | 3 | 5 | 14 |
| Argentina | 0 | 0 | 0 | 0 | 15 | 13 | 15 | 14 | 57 |
| United States | 6 | 6 | 6 | 7 | 12 | 13 | 15 | 6 | 71 |
| Japan | 0 | 0 | 0 | 0 | 6 | 6 | 6 | 7 | 25 |
| Spain | 0 | 0 | 0 | 0 | 1 | 3 | 3 | 6 | 13 |
| South Korea | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 3 | 8 |
| Austria | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Poland | 0 | 0 | 2 | 1 | 9 | 9 | 4 | 7 | 32 |
| Italy | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 5 | 10 |
| Mexico | 3 | 3 | 2 | 0 | 10 | 6 | 7 | 4 | 35 |
| South Africa | 0 | 0 | 0 | 0 | 2 | 3 | 5 | 3 | 13 |
| Slovakia | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 4 |
| Australia | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European union (EU), whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · www.clinicalstudydatarequest.com
Ran from Aug 2016 to primary completion in Apr 2018, 20 months.
Results were first posted in Oct 2019, 1 year 5 months after primary completion. A results delay was requested in Apr 2019.
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Studies of the drug tested here: Poseltinib