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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02628028




Registration number
NCT02628028
Ethics application status
Date submitted
9/12/2015
Date registered
11/12/2015

Titles & IDs
Public title
A Study of LY3337641 in Rheumatoid Arthritis
Scientific 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
Secondary ID [1] 0 0
I8K-MC-JPDA
Secondary ID [2] 0 0
16173
Universal Trial Number (UTN)
Trial acronym
RAjuvenate
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3337641
Treatment: Drugs - Placebo

Experimental: Part A 5 mg LY3337641 - Given once a day for 4 weeks.

Experimental: Part A 10 mg LY3337641 - Given once a day for 4 weeks.

Experimental: Part A 30 mg LY3337641 - Given once a day for 4 weeks.

Placebo comparator: Part A Placebo - Given once a day for 4 weeks.

Experimental: Part B 5 mg LY3337641 - Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Experimental: Part B 10 mg LY3337641 - Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Experimental: Part B 30 mg LY3337641 - Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Placebo comparator: Part B Placebo - Given once a day for 12 weeks.


Treatment: Drugs: LY3337641
Administered orally

Treatment: Drugs: Placebo
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 6 Weeks
Primary outcome [2] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response in Part B
Timepoint [2] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response in Part B
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response in Part B
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Change From Baseline in the Disease Activity Score (DAS) 28-high-sensitivity C-reactive Protein (hsCRP) in Part B
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Percentage of Participants Who Achieve Low Disease Activity Using DAS28-hsCRP in Part B
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants Who Achieve Clinical Remission Using DAS28-hsCRP in Part B
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Pharmacokinetics (PK): Clearance Parameter of LY3337641
Timepoint [6] 0 0
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)

Eligibility
Key inclusion criteria
* 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)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/08/2018
Sample size
Target
Accrual to date
Final
286
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
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. - Maroochydore
Recruitment hospital [2] 0 0
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. - Woodville South
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Kentucky
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United States of America
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Missouri
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North Carolina
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South Carolina
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United States of America
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Texas
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Cordoba
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Argentina
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Rosario
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Argentina
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San Fernando
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Argentina
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San Juan
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Argentina
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San Miguel de Tucuman
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Argentina
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Tucuman
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Austria
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Innsbruck
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Austria
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Wien
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Italy
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Firenze
Country [21] 0 0
Italy
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Milano
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Italy
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Torino
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Japan
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Asahikawa
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Japan
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Chiba
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Japan
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Fukuoka
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Hokkaido
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Kitakyushu
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Nagano
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Omura
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Sapporo
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Sasebo
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Japan
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Sendai
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Korea, Republic of
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Jung-gu
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Korea, Republic of
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Seoul
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Mexico
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Col. Roma
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Mexico
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Distrito Federal
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Mexico
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Mexicali
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Mexico
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Mexico City
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Poland
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Elblag
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Gdansk
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Poland
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Nadarzyn
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Poland
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Warsaw
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Puerto Rico
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Caguas
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Puerto Rico
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San Juan
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Puerto Rico
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Santurce
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Slovakia
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Bratislava
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Slovakia
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Zvolen
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South Africa
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Pinelands
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South Africa
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Stellenbosch
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South Africa
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Umhlanga
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Spain
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Alicante
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Spain
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Bilbao
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Spain
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Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02628028