Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis

Phase 1

• Conditions: Relapsing Multiple Sclerosis; MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-004972-20-AT
• Lead Sponsor: Merck Healthcare KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-26
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 930

Inclusion Criteria

For DBTP:
- 18 years to 55 years female and male participants
- Participants are diagnosed with RMS (relapsing-remitting multiple
sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS]
with relapses) in accordance with 2017 Revised McDonald criteria
(Thompson 2018)
- Participants with one or more documented relapses within the 2 years
before Screening with either: a. one relapse which occurred within the
last year prior to randomization, OR b. the presence of at least 1
gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to
randomization
- Participants have Expanded Disability Status Scale (EDSS) score of 0 to
5.5 at Screening and Baseline (Day 1). Participants with an EDSS score
<= 2 at Screening and Baseline (Day 1) are only eligible for participation
if their disease duration (time since onset of symptoms) is no more than
10 years
- Participants are neurologically stable for >= 30 days prior to both
screening and baseline
- Female participants must be neither pregnant nor breast-feeding or
must lack child-bearing potential (as defined by either: post-menopausal
or surgically sterile), or use an effective method of contraception for the
duration of the study and at least 2 years after study intervention due to
the long elimination period for teriflunomide of 2 years, unless the
participant undergoes an accelerated elimination procedure
- Male participants must refrain from donating sperm and/or abstain
from intercourse with women of child-bearing potential or use an
effective method of contraception for the duration of the study and at
least 2 years after study intervention due to the long elimination period
for teriflunomide of 2 years, unless the participant undergoes an
accelerated elimination procedure
- Participants have given written informed consent prior to any study related
procedure
- Other protocol defined inclusion criteria could apply.
For DBE period:
- Participants need to be able and willing to provide written informed
consent for the DBE period before the first procedure in DBE.
- Participant does not fulfill any permanent discontinuation criteria
based on Week 156/EODBTP assessments.
For OLE period:
- participants have completed the DBE period, or are still under study
treatment when enrollment into OLE is opened - but not into the longterm
follow-up study -, and who, in the opinion of the Investigator, may
benefit from treatment with evobrutinib.
- participants are able and willing to provide written informed consent
for the OLE period (e.g., before the first OLE procedure on OLE Day 1)
and to comply with the study protocol.
- participants have documentation of completed AEP (confirmed blood concentration level of < 0.02 µg/mL of teriflunomide as defined in
protocol) before Day 1/Baseline visit (applicable to all participants
previously treated with teriflunomide, or with an unknown exposure
status during the DBTP and DBE period).
- Women of childbearing potential are willing to continue to use the
contraceptive methods as described in protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 930
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

For DBTP:
- Participants diagnosed with Progressive MS, in accordance with the
2017 Revised McDonald criteria as follows: a). Participants with Primary
Progressive MS. b) Participants with secondary progressive MS without
evidence of relapse.
- Disease duration more than (>) 10 years in participants with an EDSS
=< 2.0 at screening.
- Immunologic disorder other than MS, or any other condition requiring
oral, intravenous (IV) , intramuscular, or intra-articular corticosteroid
therapy, with the exception of well-controlled Type 2 diabetes mellitus
or well controlled thyroid disease.
-Other protocol defined exclusion criteria could apply.
For OLE period:
- Participants who did not complete study intervention in DBE period.
- Treatment with injectable (e.g., IV, intramuscular, intra-articular) or
oral glucocorticoids, or ACTH (e.g., Acthar gel) within 30 days before
OLE Day 1, with the exception of rescue treatment for MS relapse
specified by the study protocol.
- History of suicidal ideation or an episode of clinically severe depression
(as determined by the Investigator) within 12 weeks prior to OLE Day 1.
- History of abnormal laboratory results that, in the opinion of the
Investigator, are indicative of a significant cardiac, endocrine,
hematologic, immunologic, metabolic urologic, pulmonary,
gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than
MS), and/or other major diseases. Any of the following abnormal blood
tests during the DBE Period requiring discontinuation of study
intervention, and/or at End of DBE visit, within a week before OLE Day 1:
ALT/serum glutamate pyruvate transaminase, AST/serum glutamic
oxaloacetic transaminase, Total Bilirubin, amylase, or lipase, eGFR.
- Female participants who have a positive pregnancy test result, are
pregnant, or are currently breast feeding.
- Inability to comply with study requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified