Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease

Study Purpose

The purpose of this study is to determine how safe and effective the study drug Olokizumab is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully responding to treatment with methotrexate (MTX).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Subjects willing and able to sign informed consent - Subjects must have a diagnosis of adult onset RA classified by ACR/EULAR 2010 revised classification criteria for RA for at least 12 weeks prior to Screening.

- Inadequate response to treatment with MTX for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week (or ≥10 mg/week if intolerant to higher doses) - The dose and means of administering MTX must have been stable for at least 6 weeks prior to Screening.

- Subjects must be willing to take folic acid or equivalent throughout the study.

- Subjects must have moderately to severely active RA disease as defined by all of the following: - ≥6 tender joints (68 joint count) at Screening and baseline; and - ≥6 swollen joints (66 joint count) at Screening and baseline; and - CRP above ULN at Screening based on the central laboratory results
Exclusion Criteria:
- Diagnosis of any other inflammatory arthritis or systemic rheumatic disease (e.g., gout, psoriatic or reactive arthritis, Crohn's disease, Lyme disease, juvenile idiopathic arthritis, or systemic lupus erythematosus) - Prior exposure to any licensed or investigational compound directly or indirectly targeting IL 6 or IL 6R (including tofacitinib or other Janus kinases and spleen tyrosine kinase [SYK] inhibitors) - Prior treatment with cell depleting therapies including anti CD20 or investigational agents (e.g., CAMPATH, anti CD4, anti CD5, anti CD3, and anti CD19) - Prior use of bDMARDs - Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or change in dosage within 2 weeks prior to baseline - Prior history of no response to hydroxychloroquine and sulfasalazine - Prior use of cDMARDs (other than MTX) within the following windows prior to baseline (cDMARDs should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA): 1.

4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or doxycycline 2. 12 weeks for leflunomide unless the subject has completed the following elimination procedure at least 4 weeks prior to baseline: Cholestyramine at a dosage of 8 grams 3 times daily for at least 24 hours, or activated charcoal at a dosage of 50 grams 4 times daily for at least 24 hours 3. 24 weeks for cyclophosphamide

- Participation in any other investigational drug study within 30 days or 5 times the terminal half-life of the investigational drug, whichever is longer, prior to baseline - Other treatments for RA (e.g., Prosorba Device/Column) within 6 months prior to baseline - Abnormal laboratory values - Subjects with concurrent acute or chronic viral hepatitis B or C infection - Subjects with HIV infection - Subjects with: 1.

Current active TB disease or a history of active TB disease. 2. Close contact with an individual with active TB within 1.5 years prior to Screening 3. History of untreated latent TB infection (LTBI), regardless of IGRA result at Screening 4. Positive interferon-gamma release assay (IGRA) result at Screening. If indeterminate, the IGRA can be repeated once during the Screening Period. If there is a second indeterminate result, the subject will be excluded. - Concurrent malignancy or a history of malignancy within the last 5 years - Uncontrolled diabetes mellitus - History of chronic alcohol or drug abuse as judged by the Investigator - Female subjects who are pregnant, currently lactating - Female subjects of childbearing potential who are not willing to use a highly effective method of contraception during the study OR Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study - Subjects with a known hypersensitivity to any component of the OKZ drug product, adalimumab, or placebo - Other exclusion criteria may apply

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02760407
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	R-Pharm
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mikhail Samsonov
Principal Investigator Affiliation	R-Pharm
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	Argentina, Brazil, Bulgaria, Colombia, Czechia, Estonia, Germany, Hungary, Korea, Republic of, Latvia, Lithuania, Mexico, Poland, Romania, Russian Federation, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis

Additional Details

The goal of this Phase III study is to assess the safety, tolerability, and efficacy of OKZ in subjects with moderately to severely active RA who have responded inadequately to MTX. The primary endpoint of the trial is at Week 12. Olokizumab is expected to reduce the disease activity and improve physical function. The study is expected to provide safety information in a large group of subjects over at least a 24 week period. Adalimumab 40 mg q2w SC has been included as the active comparator for assay sensitivity and non inferiority evaluations.

Arms & Interventions

Arms

Experimental: Arm 1: Olokizumab q4w + Methotrexate

Experimental, Olokizumab 64mg q4w Subcutaneous + Methotrexate (oral)

Experimental: Arm 2: Olokizumab q2w + Methotrexate

Experimental, Olokizumab 64mg q2w Subcutaneous + Methotrexate (oral)

Active Comparator: Arm 3: Adalimumab q2w + Methotrexate

Active Comparator, Adalimumab 40mg q2w Subcutaneous + Methotrexate (oral)

Placebo Comparator: Arm 4: Placebo q2w + Methotrexate

Placebo Comparator, Placebo q2w Subcutaneous + Methotrexate (oral)

Interventions

Drug: - Olokizumab 64mg q4w

Drug: - Olokizumab 64mg q2w

Drug: - Adalimumab 40mg q2w

Drug: - Placebo q2w

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rheumatology Associates, Portland, Maine

Status

Withdrawn

Address

Rheumatology Associates

Portland, Maine, 04102

Huntsville, Alabama

Status

Withdrawn

Address

Rheumatology Associates Of North Alabama- RANA

Huntsville, Alabama, 35801

Glendale, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Associates, P.C.

Glendale, Arizona, 85304

Site Contact

Saima Chohan

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