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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 May 2023 |
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Main ID: |
NCT04711148 |
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Date of registration:
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08/01/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity |
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Date of first enrolment:
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March 1, 2021 |
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Target sample size:
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160 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04711148 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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China
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Poland
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Ukraine
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Are 18 to 55 years of age at the time of signing the informed consent.
2. Are diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS).
3. Are neurologically stable for = 30 days prior to both Screening and Baseline.
4. One or more documented relapses within the 2 years before Screening
5. Have an EDSS score of 0 to 5.5 at Screening and Baseline (Day 1)
6. Women of childbearing potential must use effective method of contraception
7. Signed and dated informed consent
8. Patient currently participating in the Core Part who has completed the end of
treatment visit and will be benefit from continued treatment per investigator's
assessment. (OLE Part only)
Exclusion Criteria:
1. Diagnosed with progressive MS.
2. Disease duration > 10 years in participants with an EDSS = 2.0 at Screening and
Baseline (Day 1).
3. Immunologic disorder other than MS.
4. History or current diagnosis of other neurological disorders that may mimic MS.
5. History or current diagnosis of progressive multifocal leukoencephalopathy (PML).
6. History of myocardial infarction or cerebrovascular event within 6 months prior to
Screening,
7. A history of attempted suicide within 6 months prior to Screening or a positive
response to items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at
Screening.
8. An episode of major depression within the last 6 months prior to Screening (clinically
stable minor depression is not exclusionary).
9. History of cancer, except adequately treated basal cell or squamous cell carcinoma of
the skin
10. Breastfeeding/lactating or pregnant women
11. Participants are excluded from participation in the study if taken prohibited
medications/treatments.
12. Participation in any investigational drug study within 6 months or 5 half-lives of the
investigational drug, whichever is longest, prior to Screening.
13. Permanent discontinuation from the Core Part due to AE/ SAE or abnormal abnormalities
or conditions leading to permanent study drug discontinuation. (OLE Part only)
14. Patient who has new abnormality appeared in the Core Part. (OLE Part only)
15. Any significant change in the subject's medical history that would preclude
administration of the study drug. (OLE Part only)
16. Clinically significant laboratory abnormalities from the most recently available test
in the Core Part that would preclude administration of the study drug. (OLE Part only)
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Relapsing Remitting Multiple Sclerosis
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Intervention(s)
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Drug: orelabrutinib
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Other: placebo
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Primary Outcome(s)
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The cumulative number of new GdE T1 MRI brain lesions
[Time Frame: up to 120 weeks]
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Secondary Outcome(s)
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability ]
[Time Frame: up to 120 weeks]
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ARR[efficacy]
[Time Frame: up to 120 weeks]
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Secondary ID(s)
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ICP-CL-00112
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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