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A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04711148
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Beijing InnoCare Pharma Tech Co., Ltd.

Brief Summary:
This is a randomized, double-Blind, placebo-controlled Phase 2 Study of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Other: placebo Drug: orelabrutinib Phase 2

Detailed Description:

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.

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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 : July 1, 2023
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. ARR[efficacy] [ Time Frame: up to 120 weeks ]
    Annualized relapse rate in the OLE Part


Other Outcome Measures:
  1. Peak concentration (Cmax) [ Time Frame: up to 120 weeks ]
    Dose Escalation Peak concentration (Cmax)



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Olivia Yang +1 (609) 524-0684 ClinicalTrialsInfo@innocarepharma.com

Locations
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Sponsors and Collaborators
Beijing InnoCare Pharma Tech Co., Ltd.
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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: May 18, 2022
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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