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M2591

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Merck & Company, Inc.|Last Updated: Sep 28, 2020

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment390

FDA Designations

No designations recorded

Clinical trial landscape

M2591 · 1 trial · 1 indication

Phase 2 1
NCT03233230Phase IIb Study of Evobrutinib in Subjects With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED390 Analytics
PHASE2COMPLETED
Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Who Achieved American College of Rheumatology 20 Percent (%) Response Criteria (ACR20) Assessed Using High-Sensitivity C-reactive Protein (hsCRP) at Week 12
Week 12

ACR20 response: a participant has at least 20% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with 20% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI); and 5) acute phase reactant as measured by high-sensitivity C-reactive protein (hsCRP). Percentage of participants with ACR20 response using hsCRP = Number of participants with ACR20 response using hsCRP divided by total modified intent-to-treat (mITT) participants \* 100.

Secondary Endpoints

Percentage of Participants With Low Disease Activity Score (DAS28 Less Than [<] 3.2) Based on 28 Joint Count-High-Sensitivity C-reactive Protein (DAS28-hsCRP) at Week 12
Week 12
Percentage of Participants With Remission Disease Activity Score (DAS28 Less Than [<] 2.6) Based on a 28 Joint Count-High-Sensitivity C-reactive Protein (DAS28-hsCRP) at Week 12
Week 12
Percentage of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50)
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
M2951 25 mg QDEXPERIMENTAL -
M2951 75 mg QDEXPERIMENTAL -
M2951 50 mg BIDEXPERIMENTAL -

Interventions

NameTypeDescription
M2591 25 mg QDDRUGParticipants received 25 milligrams (mg) of M2951 orally once daily (QD) for 12 weeks.
M2951 75 mg QDDRUGParticipants received 75 mg of M2951 orally QD for 12 weeks.
M2951 50 mg BIDDRUGParticipants received 50 mg of M2951 orally twice daily (BID) for 12 weeks.
PlaceboDRUGParticipants received placebo matched to M2951 orally for 12 weeks.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites98

Inclusion Criteria: * 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 o...

Countries:United StatesArgentinaBulgariaChileColombiaCzechiaMexicoPolandRussiaSerbiaSouth AfricaUkraine
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Frequently asked questions about M2591

What is M2591 used for?

M2591 is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied as a potential therapy for this autoimmune condition.

What does M2591 target?

M2591 is a small molecule drug being developed by Merck & Company, Inc. for rheumatoid arthritis. The specific molecular target of M2591 has not been disclosed in available information. The drug is currently in Phase 2 clinical trials to evaluate its efficacy and safety in patients with this condition.

Who makes M2591?

M2591 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug as a potential treatment for rheumatoid arthritis. M2591 is currently in Phase 2 development.

What phase is M2591 in?

M2591 is currently in Phase 2 clinical development. It is an investigational drug being studied for the treatment of rheumatoid arthritis. The drug has not been approved by regulatory authorities and is still undergoing clinical evaluation to determine its safety and efficacy.

What clinical trials is M2591 in?

M2591 has been studied in one clinical trial, identified as NCT03233230, which was a Phase IIb study in subjects with rheumatoid arthritis. This trial was completed and enrolled 390 participants. The study was randomized, double-blind, and placebo-controlled, and it included sites in multiple countries.

Is M2591 the same as evobrutinib?

M2591 is also known as evobrutinib. The clinical trial NCT03233230, which studied M2591 in rheumatoid arthritis, was titled 'Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis.' This confirms that M2591 and evobrutinib refer to the same investigational drug.