NCT02628028 (RAjuvenate) is a Phase 2 clinical trial of LY3337641 in Rheumatoid Arthritis, sponsored by Eli Lilly and Company.

Who is sponsoring NCT02628028?

NCT02628028 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT02628028?

Interventions in NCT02628028: LY3337641, Placebo.

What condition does NCT02628028 study?

NCT02628028 studies Rheumatoid Arthritis.

Is NCT02628028 still recruiting?

NCT02628028 is currently terminated. Last updated 9 October 2019.

Are results published for NCT02628028?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-10-09 · How we verify

NCT02628028: RAjuvenate

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of LY3337641 in Rheumatoid Arthritis

Terminated Phase 2 Results posted Last updated 9 October 2019

What this trial tests

Phase 2 trial testing LY3337641 in Rheumatoid Arthritis in 286 participants. Terminated before completion.

Timeline

22 August 2016

Primary endpoint
25 April 2018

15 August 2018

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	286
Start date	22 August 2016
Primary completion	25 April 2018
Estimated completion	15 August 2018
Sites	71 locations across Italy, South Africa, Japan, Slovakia, Austria, Poland, Mexico, South Korea

Drugs / interventions tested

LY3337641 — full drug profile →
Placebo

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 65, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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

TEAEs

Group	Value	95% CI
Part A: Placebo	3
Part A: 5 mg LY3337641	1
Part A: 10 mg LY3337641	6
Part A: 30 mg LY3337641	2

AESIs

Group	Value	95% CI
Part A: Placebo	0
Part A: 5 mg LY3337641	0
Part A: 10 mg LY3337641	0
Part A: 30 mg LY3337641	0

SAEs

Group	Value	95% CI
Part A: Placebo	0
Part A: 5 mg LY3337641	0
Part A: 10 mg LY3337641	0
Part A: 30 mg LY3337641	0

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response in Part B Primary · 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 /

Group	Value	95% CI
Part B: Placebo	48.1	34.8 – 61.5
Part B: 5 mg LY3337641	55.4	42.3 – 68.4
Part B: 10 mg LY3337641	44.2	30.7 – 57.7
Part B: 30 mg LY3337641	50.9	37.7 – 64.1

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response in Part B Secondary · Week 12

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.

Group	Value	95% CI
Part B: Placebo	27.8	15.8 – 39.7
Part B: 5 mg LY3337641	25.0	13.7 – 36.3
Part B: 10 mg LY3337641	15.4	5.6 – 25.2
Part B: 30 mg LY3337641	29.1	17.1 – 41.1

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response in Part B Secondary · Week 12

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.

Group	Value	95% CI
Part B: Placebo	16.7	6.7 – 26.6
Part B: 5 mg LY3337641	8.9	1.5 – 16.4
Part B: 10 mg LY3337641	1.9	0.0 – 5.7
Part B: 30 mg LY3337641	16.4	6.6 – 26.1

Change From Baseline in the Disease Activity Score (DAS) 28-high-sensitivity C-reactive Protein (hsCRP) in Part B Secondary · Baseline, Week 12

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.

Group	Value	95% CI
Part B: Placebo	-1.62	± 1.447
Part B: 5 mg LY3337641	-1.55	± 1.182
Part B: 10 mg LY3337641	-1.24	± 1.146
Part B: 30 mg LY3337641	-1.80	± 1.453

Percentage of Participants Who Achieve Low Disease Activity Using DAS28-hsCRP in Part B Secondary · Week 12

Group	Value	95% CI
Part B: Placebo	27.8	15.8 – 39.7
Part B: 5 mg LY3337641	32.1	19.9 – 44.4
Part B: 10 mg LY3337641	21.2	10.1 – 32.3
Part B: 30 mg LY3337641	29.1	17.1 – 41.1

Percentage of Participants Who Achieve Clinical Remission Using DAS28-hsCRP in Part B Secondary · Week 12

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.

Group	Value	95% CI
Part B: Placebo	20.4	9.6 – 31.1
Part B: 5 mg LY3337641	19.6	9.2 – 30.0
Part B: 10 mg LY3337641	7.7	0.4 – 14.9
Part B: 30 mg LY3337641	25.5	13.9 – 37.0

Pharmacokinetics (PK): Clearance Parameter of LY3337641 Secondary · 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)

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.

Group	Value	95% CI
LY3337641	29.1	± 5.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 88 Weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: Placebo

Serious: 0/9 (0%)

Deaths: 0/9

Part A: 5 mg LY3337641

Serious: 0/9 (0%)

Deaths: 0/9

Part A: 10 mg LY3337641

Serious: 0/10 (0%)

Deaths: 0/10

Part A: 30 mg LY3337641

Serious: 0/8 (0%)

Deaths: 0/8

Part B: Placebo

Serious: 2/62 (3%)

Deaths: 0/62

Part B: 5 mg LY3337641

Serious: 0/63 (0%)

Deaths: 0/63

Part B: 10 mg LY3337641

Serious: 0/62 (0%)

Deaths: 0/62

Part B: 30 mg LY3337641

Serious: 3/63 (5%)

Deaths: 1/63

Long-Term Extension: 5 mg LY3337641

Serious: 1/61 (2%)

Deaths: 0/61

Long-Term Extension: 10 mg LY3337641

Serious: 3/58 (5%)

Deaths: 0/58

Long-Term Extension: 30 mg LY3337641

Serious: 1/61 (2%)

Deaths: 0/61

Serious adverse events (13 terms)

Reaction	System	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 …	Long-Term Extension: 10 mg…	Long-Term Extension: 30 mg…
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Foot fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Hand fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Joint dislocation	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Multiple injuries	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Patella fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Pubis fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Wrist fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—
Venous thrombosis	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (22 terms — click to expand)

Reaction	System	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 …	Long-Term Extension: 10 mg…	Long-Term Extension: 30 mg…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—	—	—	—	—
Laryngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
Hypertriglyceridaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
Osteopenia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
Carotid artery aneurysm	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
Benign prostatic hyperplasia	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—	—
Erectile dysfunction	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Cholecystitis acute, Pneumonia, Ankle fracture, Foot fracture, Hand fracture, Joint dislocation, Multiple injuries, Patella fracture.

Data from ClinicalTrials.gov NCT02628028 adverse events section.

Sponsor's own description

The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in adults with rheumatoid arthritis (RA).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Small Molecule NF-κB Pathway Inhibitors in Clinic.
Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164
Bruton's Tyrosine Kinase (BTK) Inhibitors and Autoimmune Diseases: Making Sense of BTK Inhibitor Specificity Profiles and Recent Clinical Trial Successes and Failures.
Ringheim GE, Wampole M, Oberoi K. · · 2021 · cited 100× · PMID 34803999 · DOI 10.3389/fimmu.2021.662223
Bruton's Kinase Inhibitors for the Treatment of Immunological Diseases: Current Status and Perspectives.
Robak E, Robak T. · · 2022 · cited 45× · PMID 35628931 · DOI 10.3390/jcm11102807
Recent Advances in BTK Inhibitors for the Treatment of Inflammatory and Autoimmune Diseases.
Zhang D, Gong H, Meng F. · · 2021 · cited 45× · PMID 34443496 · DOI 10.3390/molecules26164907
Bruton's Tyrosine Kinase Inhibition as an Emerging Therapy in Systemic Autoimmune Disease.
Neys SFH, Rip J, Hendriks RW, Corneth OBJ. · · 2021 · cited 41× · PMID 34609725 · DOI 10.1007/s40265-021-01592-0
Recent developments in systemic lupus erythematosus pathogenesis and applications for therapy.
Lo MS, Tsokos GC. · · 2018 · cited 31× · PMID 29206660 · DOI 10.1097/bor.0000000000000474
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.
Genovese MC, Spindler A, Sagawa A, Park W, et al · · 2021 · cited 13× · PMID 33323529 · DOI 10.3899/jrheum.200893
Target modulation and pharmacokinetics/pharmacodynamics translation of the BTK inhibitor poseltinib for model-informed phase II dose selection.
Byun JY, Koh YT, Jang SY, Witcher JW, et al · · 2021 · cited 5× · PMID 34548595 · DOI 10.1038/s41598-021-98255-7

Verify or expand the search:

Other trials of LY3337641

Trials testing the same drug.

NCT03083561 — A Study of LY3337641 in Japanese and Caucasian Healthy Participants · Phase 1 · completed

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting

Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02628028 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 9 October 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02628028.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing