Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study was to determine the efficacy, dose response, and safety of M52951 in participants with Rheumatoid Arthritis (RA), and to consider a dose to took forward into Phase III development.

Key facts

Study ID: NCT03233230
Run by: EMD Serono Research & Development Institute, Inc.
People needed: 390
Starts: 2017-09-18
Expected to finish: 2019-09-23
Last updated by the study team: 2020-09-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

In Japan, if a participant is less than (<) 20 years, the written informed consent from the participant's parent or guardian will be required in addition to the participant's written consent.
Confirmed diagnosis of RA according to 2010 ACR/EULAR RA classification criteria of at least 6 months duration prior to Screening
Persistently active moderate to severe RA at both Screening and Randomization (if significant surgical treatment of a joint has been performed, that joint cannot be counted for entry or enrollment purposes), as defined by: >= 6 swollen joints (of 66 assessed) and >= 6 tender joints (of 68 assessed).
An hsCRP >= 5.0 milligram/liter (mg/L) at Screening
Treatment for >= 16 weeks with 7.5 to 25 mg/week Methotrexate (MTX) at a stable dose and route of administration (oral or parenteral) for at least 8 weeks prior to dosing with the Investigational Medicinal Product (IMP) and maintained throughout the trial
For participants entering the trial on MTX doses < 15 mg/week (< 10 mg/week in Japan), there must be clear documentation in the medical record that higher doses of MTX were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines.
For MRI Sub-study participants, participants must have palpable synovitis of the wrist and/or >= 1 of metacarpophalangeal joints 1 to 5, defined as loss of bony contours with palpable joint effusion and/or swelling, in the MRI-designated hand (that is., the hand being used in MRI assessments).

You may not qualify if…

ACR functional class IV as defined by the ACR classification of functional status or wheelchair/bedbound
Use of oral corticosteroids greater than (>) 10 mg daily prednisone equivalent, or change in dose of corticosteroids within 2 weeks prior to Screening or during Screening
Use of injectable corticosteroids (including intra-articular corticosteroids) or intra-articular hyaluronic acid within 4 weeks prior to Screening or during Screening
Initiation or change in dose for nonsteroidal anti-inflammatory drugs (NSAIDs) (including low-dose aspirin and cyclooxygenase-2 inhibitors) within 2 weeks prior to dosing with the IMP
High potency opioid analgesics are prohibited within 2 weeks prior to Screening and during the trial; other analgesics are allowed (that is, acetaminophen, codeine, hydrocodone*, propoxyphene*, or tramadol), although not within 24 hours of study visits with clinical assessments (*not approved in Japan)
Current or prior treatment with any of the following:
Biologic Disease-modifying anti-rheumatic drugs (DMARDs) (approved or investigational), including but not limited to:
Tumor necrosis factor (TNF) antagonists or biosimilars of these agents (approved or investigational), or any investigational TNF antagonist
Interleukin-6 antagonists
Abatacept (CTLA4-Fc)
Anakinra* (IL-1 receptor antagonist) (*not approved in Japan)
B cell-depleting antibodies (example, rituximab, ocrelizumab*, ofatumumab, obinutuzumab*, ocaratuzumab*, veltuzumab*, or any biosimilars of these agents [approved or investigational]) (*not approved in Japan)
Anti-BLyS (B lymphocyte stimulator) agents (example, belimumab, tabalumab*) (*not approved in Japan)
Dual BLyS/A proliferation-inducing ligand (APRIL) neutralizing agents (that is, atacicept*, RCT-18*) (*not approved in Japan)
Targeted synthetic DMARDs, specifically:
Janus kinase inhibitors
Other Bruton's tyrosine kinase (BTK) inhibitors
Alkylating agents (example, chlorambucil*, cyclophosphamide) (*not approved in Japan).
The following restrictions on nonbiologic DMARD must be followed:
Auranofin (Ridaura), minocycline, penicillamine, sulfasalazine, cyclosporine, mycophenolate (mycophenolate sodium not approved in Japan), tacrolimus, azathioprine: must have been discontinued for 4 weeks prior to dosing with the IMP
Leflunomide (Arava) must have been discontinued 12 weeks prior to dosing with the IMP if no elimination procedure is followed. Alternately, it should have been discontinued with the following elimination procedure at least 4 weeks prior to dosing with the IMP:
Cholestyramine at a dosage of 8 gram 3 times a day for at least 24 hours, or activated charcoal at a dosage of 50 gram 4 times a day for at least 24 hours.
Injectable Gold (aurothioglucose* or aurothiomalate): must have been discontinued for 8 weeks prior to dosing with the IMP (*not approved in Japan)
Anti-malarials (hydroxychloroquine, chloroquine*) will be allowed in this trial. Participants may be taking oral hydroxychloroquine (=< 400 mg/day) or chloroquine (=< 250 mg/day), doses must have been stable for at least 12 weeks prior to dosing with the IMP, and will need to be continued at that stable dose for the duration of the trial. If discontinued prior to this trial, they must have been discontinued for 4 weeks prior to dosing with the IMP (*not approved in Japan).
For MRI Substudy:

Where it is running

Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona, United States
East Bay Rheumatology Medical Group, Inc. — San Leandro, California, United States
Omega Research Consultants — DeBary, Florida, United States
Clinical Research of West Florida, Inc. — Tampa, Florida, United States
McIlwain Medical Group, PA — Tampa, Florida, United States
Medication Management, LLC — Greensboro, North Carolina, United States
Arthritis Clinic Of Central Texas — San Marcos, Texas, United States
Hospital Italiano de La Plata — La Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas — Mar del Plata, Buenos Aires, Argentina
Instituto Medico CER — Quilmes, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes — Quilmes, Buenos Aires, Argentina
Centro Medico Privado de Reumatologia — San Miguel de Tucumán, San Miguel de Tucuman, Argentina
Centro de Investigaciones Reumatológicas — San Miguel de Tucumán, Tucumán Province, Argentina
Organizacion Medica de Investigacion (OMI) — Ciudad Autonoma Buenos Aires, Argentina
APRILLUS — Ciudad Autonoma Buenos Aires, Argentina
Expertia S.A- Mautalen Salud e Investigación — Ciudad Autonoma Buenos Aires, Argentina
Hospital General de Agudos Dr. J. M. Ramos Mejia — Ciudad Autonoma Buenos Aires, Argentina
ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas — Córdoba, Argentina
Instituto Reumatológico Strusberg — Córdoba, Argentina
Centro Polivalente de Asistencia e Inv. Clinica CER — San Juan, Argentina
MHAT "Hadzhi Dimitar", OOD — Sliven, Bulgaria
DCC "Alexandrovska", EOOD — Sofia, Bulgaria
UMHAT "SofiaMed", OOD — Sofia, Bulgaria
Centro Medico Prosalud — Santiago, Chile
Arizona Arthritis & Rheumatology Associates, P.C. — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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