A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis
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| ClinicalTrials.gov Identifier: NCT04711148 |
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Recruitment Status :
Active, not recruiting
First Posted : January 15, 2021
Last Update Posted : April 21, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsing Remitting Multiple Sclerosis | Other: placebo Drug: orelabrutinib | Phase 2 |
The study contains 2 parts: Core Part and an Open-label Extension (OLE) Part.
The Core Part is a randomized, double-blind, placebo-controlled, phase 2 study. Patients with RRMS will be randomly assigned to 1 of 4 treatment groups. placebo, orelabrutinib (low dose), orelabrutinib (medium dose) and orelabrutinib (high dose) at a 1:1:1:1 ratio.
The OLE part is an open-label, single treatment arm study to enroll patients who have completed the Week 24 visit in the Core Part for continued treatment and collect additional long-term safety and efficacy data.All patients will receive the low dose of orelabrutinib or any other dose as suggested from the Core part of the study.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | March 1, 2021 |
| Estimated Primary Completion Date : | February 25, 2026 |
| Estimated Study Completion Date : | March 1, 2026 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: placebo
The Core Part：Participants receive placebo The OLE Part：Participants who have completed the Week 24 visit in the Core Part for continued treatment and collect additional long-term safety and efficacy data receive the low dose of orelabrutinib or any other dose as suggested from the Core part of the study. |
Other: placebo
placebo Drug: orelabrutinib Orelabrutinib is a white, round, uncoated tablet |
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Experimental: orelabrutinib(low dose)
The Core Part：Participants receive low dose orelabrutinib The OLE Part：Participants who have completed the Week 24 visit in the Core Part for continued treatment and collect additional long-term safety and efficacy data receive the low dose of orelabrutinib or any other dose as suggested from the Core part of the study. |
Drug: orelabrutinib
Orelabrutinib is a white, round, uncoated tablet |
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Experimental: orelabrutinib(medium dose)
The Core Part ：Participants receive medium dose orelabrutinib The OLE Part：Participants who have completed the Week 24 visit in the Core Part for continued treatment and collect additional long-term safety and efficacy data receive the low dose of orelabrutinib or any other dose as suggested from the Core part of the study. |
Drug: orelabrutinib
Orelabrutinib is a white, round, uncoated tablet |
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Experimental: orelabrutinib (high dose)
The Core Part：Participants receive high dose orelabrutinib The OLE Part：Participants who have completed the Week 24 visit in the Core Part for continued treatment and collect additional long-term safety and efficacy data receive the low dose of orelabrutinib or any other dose as suggested from the Core part of the study. |
Drug: orelabrutinib
Orelabrutinib is a white, round, uncoated tablet |
- The cumulative number of new GdE T1 MRI brain lesions [ Time Frame: up to 120 weeks ]To evaluate the efficacy of orelabrutinib on the cumulative number of new gadolinium-enhancing (GdE) T1 magnetic resonance (MRI) brain lesions versus placebo over 12 weeks of treatment.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability ] [ Time Frame: up to 120 weeks ]To evaluate the safety and tolerability of orelabrutinib compared to placebo in the Core Part
- ARR[efficacy] [ Time Frame: up to 120 weeks ]Annualized relapse rate in the OLE Part
- Peak concentration (Cmax) [ Time Frame: up to 120 weeks ]Dose Escalation Peak concentration (Cmax)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Are 18 to 55 years of age at the time of signing the informed consent.
- Are diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS).
- Are neurologically stable for ≥ 30 days prior to both Screening and Baseline.
- One or more documented relapses within the 2 years before Screening
- Have an EDSS score of 0 to 5.5 at Screening and Baseline (Day 1)
- Women of childbearing potential must use effective method of contraception
- Signed and dated informed consent
- 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:
- Diagnosed with progressive MS.
- Disease duration > 10 years in participants with an EDSS ≤ 2.0 at Screening and Baseline (Day 1).
- Immunologic disorder other than MS.
- History or current diagnosis of other neurological disorders that may mimic MS.
- History or current diagnosis of progressive multifocal leukoencephalopathy (PML).
- History of myocardial infarction or cerebrovascular event within 6 months prior to Screening,
- 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.
- An episode of major depression within the last 6 months prior to Screening (clinically stable minor depression is not exclusionary).
- History of cancer, except adequately treated basal cell or squamous cell carcinoma of the skin
- Breastfeeding/lactating or pregnant women
- Participants are excluded from participation in the study if taken prohibited medications/treatments.
- Participation in any investigational drug study within 6 months or 5 half-lives of the investigational drug, whichever is longest, prior to Screening.
- Permanent discontinuation from the Core Part due to AE/ SAE or abnormal abnormalities or conditions leading to permanent study drug discontinuation. (OLE Part only)
- Patient who has new abnormality appeared in the Core Part. (OLE Part only)
- Any significant change in the subject's medical history that would preclude administration of the study drug. (OLE Part only)
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711148
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| Responsible Party: | Beijing InnoCare Pharma Tech Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT04711148 |
| Other Study ID Numbers: |
ICP-CL-00112 |
| First Posted: | January 15, 2021 Key Record Dates |
| Last Update Posted: | April 21, 2023 |
| Last Verified: | March 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS |
Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |