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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04711148
Other study ID # ICP-CL-00112
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date March 1, 2021
Est. completion date March 1, 2026

Study information

Verified date March 2023
Source Beijing InnoCare Pharma Tech Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 160
Est. completion date March 1, 2026
Est. primary completion date February 25, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
placebo
placebo
Drug:
orelabrutinib
Orelabrutinib is a white, round, uncoated tablet

Locations

Country Name City State
China Beijing Tiantan Hospital, Capital Medical University Beijing Beijing
China Peking Union Medical College Hospital Beijing Beijing
China The First Hospital of Jilin University Changchun Jilin
China Xiangya Hospital, Central South University Changsha Hunan
China West China Hospital, Sichuan University Chengdu Sichuan
China The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
China The First Affiliated Hospital of Anhui Medical University Hefei Anhui
China Huashan Hospital, Fudan University Shanghai Shanghai
China Shengjing Hospital of China Medical University Shengyang Liaoning
China The 1st Affiliated Hospital of Shanxi Medical University Taiyuan Shanxi
China Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei
China The Second Affiliated Hospital of Air Force Military Medical University Xi'an Shanxi
China The First Affiliated Hospital of Chongqing Medical University Yuzhong Chongqing
Poland NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis" Katowice
Poland Prywatna Praktyka Lekarska Katowice
Poland Resmedica NZOZ Kielce Kielce
Poland MCD Medical Krakow
Poland Neuromed Lublin
Poland Nzoz "Neuro-Kard" Poznan
Poland Wielospecjalistyczne Centrum Medyczne Ibismed Zabrze
Ukraine CE I.I.Mechnykov Dnipropetrovsk RC Hosp of Dnipropetrovsk RC Dept of Neurology Dnipro
Ukraine Medical Center of Dnipro State Medical University, Dnipro State Medical University Dnipro
Ukraine SI USSRI of Medical and Social Problems of Disabilities of MOHU Dnipro
Ukraine CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council Ivano-Frankivsk
Ukraine CIH Kharkiv City General Practice Kharkiv
Ukraine Institute of Neurology, Psychiatry and Narcology of NAMSU Kharkiv
Ukraine SI Institute of Neurology, Psychiatry and Narcology of NAMSU Kharkiv
Ukraine Medical Center of Limited Liability Company Medbud-Clinic Kyiv
Ukraine CNE City Clinical Hospital #5 of Lviv Lviv
Ukraine CNE of Lviv Reg Council Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU Lviv
Ukraine CNE Odesa Regional Clinical Hospital of Odesa Regional Council Odesa
Ukraine Medical Center of Limited Liability Company Health Clinic, Medical Clinical Research Center Vinnytsia
Ukraine Medical Center of Limited Liability Company Medical Center Saliutem Vinnytsia
Ukraine CNE Zaporizhzhia RCH of ZRC Dept of Neurology #1 Zaporizhzhia
Ukraine CNE Zaporizhzhia Regional Clinical Hospital of ZRC Zaporizhzhia
Ukraine Municipal Non-profit Enterprise "City Hospital No.6" of Zaporizhzya City Council Zaporizhzhia
Ukraine Medical Center of Limited Liability Company INET-09 Zaporizhzhya
United States Premier Neurology, P.C. Greer South Carolina
United States Neurology Associates, P.C. Lincoln Nebraska
United States Consultants in Neurology LTD Northbrook Illinois
United States Neurology Associates of Ormond Beach Ormond Beach Florida
United States University of South Florida Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Countries where clinical trial is conducted

United States,  China,  Poland,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Other Peak concentration (Cmax) Dose Escalation Peak concentration (Cmax) up to 120 weeks
Primary 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. up to 120 weeks
Secondary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability ] To evaluate the safety and tolerability of orelabrutinib compared to placebo in the Core Part up to 120 weeks
Secondary ARR[efficacy] Annualized relapse rate in the OLE Part up to 120 weeks
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