A Study of LY3337641 in Rheumatoid Arthritis (RAjuvenate)

Lilly

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: LY3337641

Study type: Interventional

Funder types: Industry

Identifiers

NCT02628028

2015-003289-97 (EudraCT Number)

I8K-MC-JPDA (Other Identifier)

16173

Details and patient eligibility

About

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

Enrollment: 286 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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286 participants in 8 patient groups, including a placebo group

Part A 5 mg LY3337641

Experimental group

Description:

Given once a day for 4 weeks.

Treatment:

Drug: LY3337641

Part A 10 mg LY3337641

Experimental group

Description:

Given once a day for 4 weeks.

Treatment:

Drug: LY3337641

Part A 30 mg LY3337641

Experimental group

Description:

Given once a day for 4 weeks.

Treatment:

Drug: LY3337641

Part A Placebo

Placebo Comparator group

Description:

Given once a day for 4 weeks.

Treatment:

Drug: Placebo

Part B 5 mg LY3337641

Experimental group

Description:

Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Treatment:

Drug: LY3337641

Part B 10 mg LY3337641

Experimental group

Description:

Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Treatment:

Drug: LY3337641

Part B 30 mg LY3337641

Experimental group

Description:

Given once a day for 12 weeks and an additional 52 weeks for Long-term extension (LTE) period.

Treatment:

Drug: LY3337641

Part B Placebo

Placebo Comparator group

Description:

Given once a day for 12 weeks.

Treatment:

Drug: Placebo