NCT02628028

Brief Summary

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

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Aug 2016

Typical duration for phase_2 rheumatoid-arthritis

Geographic Reach
12 countries

69 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

August 22, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 9, 2019

Completed
Last Updated

October 9, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

December 9, 2015

Results QC Date

August 9, 2019

Last Update Submit

September 19, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Week 12

Secondary Outcomes (6)

  • Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response in Part B

    Week 12

  • Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response in Part B

    Week 12

  • Change From Baseline in the Disease Activity Score (DAS) 28-high-sensitivity C-reactive Protein (hsCRP) in Part B

    Baseline, Week 12

  • Percentage of Participants Who Achieve Low Disease Activity Using DAS28-hsCRP in Part B

    Week 12

  • Percentage of Participants Who Achieve Clinical Remission Using DAS28-hsCRP in Part B

    Week 12

  • +1 more secondary outcomes

Study Arms (8)

Part A 5 mg LY3337641

EXPERIMENTAL

Given once a day for 4 weeks.

Drug: LY3337641

Part A 10 mg LY3337641

EXPERIMENTAL

Given once a day for 4 weeks.

Drug: LY3337641

Part A 30 mg LY3337641

EXPERIMENTAL

Given once a day for 4 weeks.

Drug: LY3337641

Part A Placebo

PLACEBO COMPARATOR

Given once a day for 4 weeks.

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.

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.

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.

Drug: LY3337641

Part B Placebo

PLACEBO COMPARATOR

Given once a day for 12 weeks.

Drug: Placebo

Interventions

LY3337641DRUG

Administered orally

Part A 10 mg LY3337641Part A 30 mg LY3337641Part A 5 mg LY3337641Part B 10 mg LY3337641Part B 30 mg LY3337641Part B 5 mg LY3337641
PlaceboDRUG

Administered orally

Part A PlaceboPart B Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (71)

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

Stanford University Hospital

Palo Alto, California, 94304, United States

Location

Denver Arthritis Center

Denver, Colorado, 80230, United States

Location

Innovative Research of West Florida

Clearwater, Florida, 33756, United States

Location

Jeffrey Alper MD Research

Naples, Florida, 34102, United States

Location

Sun Coast Clinical Research, Inc

New Port Richey, Florida, 34652, United States

Location

Lovelace Scientific Resources

Venice, Florida, 34292, United States

Location

Center for Arthritis & Osteoporosis

Elizabethtown, Kentucky, 42701, United States

Location

Clayton Medical Research

St Louis, Missouri, 63117, United States

Location

Rowan Regional Medical Center

Salisbury, North Carolina, 28144, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

North Charleston, South Carolina, 29406, United States

Location

Accurate Clinical Research

League City, Texas, 77573, United States

Location

Accurate Clinical Research

Nassau Bay, Texas, 77058, United States

Location

Rheumatology and Immunotherapy Center

Franklin, Wisconsin, 53132, United States

Location

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, Argentina

Location

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Ciudad Autonoma de Buenos Aire, C1015ABO, Argentina

Location

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Ciudad Autonoma de Buenos Aire, C1128AAF, Argentina

Location

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Ciudad Autonoma de Buenos Aire, C1204AAD, Argentina

Location

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Ciudad Autonoma de Buenos Aire, C1426AAL, Argentina

Location

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Ciudad Autonoma de Buenos Aire, c1440AAD, Argentina

Location

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Córdoba, X5000EDC, Argentina

Location

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Rosario, S2000CFJ, Argentina

Location

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Rosario, S2000PBJ, Argentina

Location

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San Fernando, B1646DBM, Argentina

Location

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San Juan, J5402DIL, Argentina

Location

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San Miguel de Tucumán, 4000, Argentina

Location

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San Miguel de Tucumán, T4000AXL, Argentina

Location

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Maroochydore, 4558, Australia

Location

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Woodville South, 5011, Australia

Location

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Innsbruck, 6020, Austria

Location

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Vienna, 1090, Austria

Location

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Florence, 50139, Italy

Location

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Milan, 20157, Italy

Location

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Torino, 10154, Italy

Location

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Asahikawa, 070-8644, Japan

Location

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Chiba, 275-8580, Japan

Location

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Fukuoka, 810-8539, Japan

Location

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Fukuoka, 810-8563, Japan

Location

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Hokkaido, 060-0001, Japan

Location

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Kitakyushu, 807-8556, Japan

Location

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Nagano, 380-8582, Japan

Location

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Ōmura, 856-8562, Japan

Location

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Sapporo, 060-0004, Japan

Location

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Sapporo, 060-8648, Japan

Location

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Sasebo, 857-1195, Japan

Location

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Sendai, 980-8574, Japan

Location

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Colonia Roma, 6700, Mexico

Location

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Distrito Federal, 3100, Mexico

Location

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Mexicali, 21100, Mexico

Location

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Mexico City, 06700, Mexico

Location

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Elblag, 82-300, Poland

Location

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Gdansk, 80-546, Poland

Location

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Nadarzyn, 05-830, Poland

Location

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Warsaw, 03-291, Poland

Location

Office: Perez-De Jesus, Amarilis

Caguas, PR, 00725, Puerto Rico

Location

Mindful Medical Research

San Juan, PR, 00918, Puerto Rico

Location

Latin Clinical Trial Center

Santurce, 00909, Puerto Rico

Location

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.

Bratislava, 85101, Slovakia

Location

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Zvolen, 96001, Slovakia

Location

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Pinelands, 7405, South Africa

Location

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Stellenbosch, 7600, South Africa

Location

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Umhlanga, 4319, South Africa

Location

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Junggu, 22332, South Korea

Location

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Seoul, 04763, South Korea

Location

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Seoul, 05030, South Korea

Location

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Seoul, 06591, South Korea

Location

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Seoul, 07345, South Korea

Location

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Alicante, 03570, Spain

Location

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Bilbao, 48013, Spain

Location

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Seville, 41010, Spain

Location

Related Publications (1)

  • 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.

    PMID: 33323529DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

The trial was terminated after an interim analysis of efficacy and safety data did not warrant continuation of the trial.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 11, 2015

Study Start

August 22, 2016

Primary Completion

April 25, 2018

Study Completion

August 15, 2018

Last Updated

October 9, 2019

Results First Posted

October 9, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
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.
More information

Locations

ME(4)AR(13)AU(2)PR(3)US(15)KR(5)PL(4)SL(2)ES(3)ZA(3)IT(3)JP(12)