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

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
placebo
orelabrutinib
Sponsored by
Beijing InnoCare Pharma Tech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Neurology Associates of Ormond Beach
  • University of South Florida
  • Consultants in Neurology LTD
  • Neurology Associates, P.C.
  • Premier Neurology, P.C.
  • The First Affiliated Hospital of Anhui Medical University
  • Peking Union Medical College Hospital
  • Beijing Tiantan Hospital, Capital Medical University
  • The First Affiliated Hospital of Chongqing Medical University
  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Xiangya Hospital, Central South University
  • The First Hospital of Jilin University
  • Shengjing Hospital of China Medical University
  • Huashan Hospital, Fudan University
  • The 1st Affiliated Hospital of Shanxi Medical University
  • The Second Affiliated Hospital of Air Force Military Medical University
  • West China Hospital, Sichuan University
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"
  • Prywatna Praktyka Lekarska
  • Resmedica NZOZ Kielce
  • MCD Medical
  • Neuromed
  • Nzoz "Neuro-Kard"
  • Wielospecjalistyczne Centrum Medyczne Ibismed
  • CE I.I.Mechnykov Dnipropetrovsk RC Hosp of Dnipropetrovsk RC Dept of Neurology
  • Medical Center of Dnipro State Medical University, Dnipro State Medical University
  • SI USSRI of Medical and Social Problems of Disabilities of MOHU
  • CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council
  • Institute of Neurology, Psychiatry and Narcology of NAMSU
  • SI Institute of Neurology, Psychiatry and Narcology of NAMSU
  • CIH Kharkiv City General Practice
  • Medical Center of Limited Liability Company Medbud-Clinic
  • CNE of Lviv Reg Council Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU
  • CNE City Clinical Hospital #5 of Lviv
  • CNE Odesa Regional Clinical Hospital of Odesa Regional Council
  • Medical Center of Limited Liability Company Health Clinic, Medical Clinical Research Center
  • Medical Center of Limited Liability Company Medical Center Saliutem
  • Municipal Non-profit Enterprise "City Hospital No.6" of Zaporizhzya City Council
  • CNE Zaporizhzhia RCH of ZRC Dept of Neurology #1
  • CNE Zaporizhzhia Regional Clinical Hospital of ZRC
  • Medical Center of Limited Liability Company INET-09

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

placebo

orelabrutinib(low dose)

orelabrutinib(medium dose)

orelabrutinib (high dose)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

The cumulative number of new GdE T1 MRI brain lesions
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

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability ]
To evaluate the safety and tolerability of orelabrutinib compared to placebo in the Core Part
ARR[efficacy]
Annualized relapse rate in the OLE Part

Full Information

First Posted
January 8, 2021
Last Updated
April 20, 2023
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04711148
Brief Title
A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
February 25, 2026 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
orelabrutinib(low dose)
Arm Type
Experimental
Arm Description
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.
Arm Title
orelabrutinib(medium dose)
Arm Type
Experimental
Arm Description
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.
Arm Title
orelabrutinib (high dose)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
orelabrutinib
Intervention Description
Orelabrutinib is a white, round, uncoated tablet
Primary Outcome Measure Information:
Title
The cumulative number of new GdE T1 MRI brain lesions
Description
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.
Time Frame
up to 120 weeks
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability ]
Description
To evaluate the safety and tolerability of orelabrutinib compared to placebo in the Core Part
Time Frame
up to 120 weeks
Title
ARR[efficacy]
Description
Annualized relapse rate in the OLE Part
Time Frame
up to 120 weeks
Other Pre-specified Outcome Measures:
Title
Peak concentration (Cmax)
Description
Dose Escalation Peak concentration (Cmax)
Time Frame
up to 120 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Neurology Associates of Ormond Beach
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Consultants in Neurology LTD
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Neurology Associates, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Premier Neurology, P.C.
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Yuzhong
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shengyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
The 1st Affiliated Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
The Second Affiliated Hospital of Air Force Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Prywatna Praktyka Lekarska
City
Katowice
ZIP/Postal Code
40-571
Country
Poland
Facility Name
Resmedica NZOZ Kielce
City
Kielce
ZIP/Postal Code
25-726
Country
Poland
Facility Name
MCD Medical
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Neuromed
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Nzoz "Neuro-Kard"
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Wielospecjalistyczne Centrum Medyczne Ibismed
City
Zabrze
ZIP/Postal Code
41-807
Country
Poland
Facility Name
CE I.I.Mechnykov Dnipropetrovsk RC Hosp of Dnipropetrovsk RC Dept of Neurology
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Medical Center of Dnipro State Medical University, Dnipro State Medical University
City
Dnipro
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
SI USSRI of Medical and Social Problems of Disabilities of MOHU
City
Dnipro
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Institute of Neurology, Psychiatry and Narcology of NAMSU
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
SI Institute of Neurology, Psychiatry and Narcology of NAMSU
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
CIH Kharkiv City General Practice
City
Kharkiv
ZIP/Postal Code
61172
Country
Ukraine
Facility Name
Medical Center of Limited Liability Company Medbud-Clinic
City
Kyiv
ZIP/Postal Code
3110
Country
Ukraine
Facility Name
CNE of Lviv Reg Council Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
CNE City Clinical Hospital #5 of Lviv
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
CNE Odesa Regional Clinical Hospital of Odesa Regional Council
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Medical Center of Limited Liability Company Health Clinic, Medical Clinical Research Center
City
Vinnytsia
ZIP/Postal Code
21009
Country
Ukraine
Facility Name
Medical Center of Limited Liability Company Medical Center Saliutem
City
Vinnytsia
ZIP/Postal Code
21050
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise "City Hospital No.6" of Zaporizhzya City Council
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
CNE Zaporizhzhia RCH of ZRC Dept of Neurology #1
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
CNE Zaporizhzhia Regional Clinical Hospital of ZRC
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Medical Center of Limited Liability Company INET-09
City
Zaporizhzhya
ZIP/Postal Code
69035
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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