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

NCT04711148 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: ICP-CL-00112
• Study Type: interventional
• Target: 160
• Locations: 4 countries
• Sites: 42

Brief Summary

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

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability ]

  up to 120 weeks

• ARR[efficacy]

  up to 120 weeks

Other Outcomes (1)

• Peak concentration (Cmax)

  up to 120 weeks

Study Arms (4)

placebo

PLACEBO COMPARATOR

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; Drug: orelabrutinib

orelabrutinib(low dose)

EXPERIMENTAL

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(medium dose)

EXPERIMENTAL

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 (high dose)

EXPERIMENTAL

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

Interventions

placebo OTHER

placebo

placebo

orelabrutinib DRUG

Orelabrutinib is a white, round, uncoated tablet

orelabrutinib (high dose); orelabrutinib(low dose); orelabrutinib(medium dose); placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (42)

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Consultants in Neurology LTD

Northbrook, Illinois, 60062, United States

Location

Neurology Associates, P.C.

Lincoln, Nebraska, 68510, United States

Location

Premier Neurology, P.C.

Greer, South Carolina, 29650, United States

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

The First Affiliated Hospital of Chongqing Medical University

Yuzhong, Chongqing Municipality, 400016, China

Location

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430060, China

Location

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Shengjing Hospital of China Medical University

Shengyang, Liaoning, 110004, China

Location

The 1st Affiliated Hospital of Shanxi Medical University

Taiyuan, Shan'xi, China

Location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

The Second Affiliated Hospital of Air Force Military Medical University

Xi’an, Shanxi, 710038, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"

Katowice, 40-123, Poland

Location

Prywatna Praktyka Lekarska

Katowice, 40-571, Poland

Location

Resmedica NZOZ Kielce

Kielce, 25-726, Poland

Location

MCD Medical

Krakow, 31-637, Poland

Location

Neuromed

Lublin, 20-954, Poland

Location

Nzoz "Neuro-Kard"

Poznan, 61-853, Poland

Location

Wielospecjalistyczne Centrum Medyczne Ibismed

Zabrze, 41-807, Poland

Location

CE I.I.Mechnykov Dnipropetrovsk RC Hosp of Dnipropetrovsk RC Dept of Neurology

Dnipro, 49005, Ukraine

Location

Medical Center of Dnipro State Medical University, Dnipro State Medical University

Dnipro, 49027, Ukraine

Location

SI USSRI of Medical and Social Problems of Disabilities of MOHU

Dnipro, 49027, Ukraine

Location

CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council

Ivano-Frankivsk, 76008, Ukraine

Location

Institute of Neurology, Psychiatry and Narcology of NAMSU

Kharkiv, 61068, Ukraine

Location

SI Institute of Neurology, Psychiatry and Narcology of NAMSU

Kharkiv, 61068, Ukraine

Location

CIH Kharkiv City General Practice

Kharkiv, 61172, Ukraine

Location

Medical Center of Limited Liability Company Medbud-Clinic

Kyiv, 3110, Ukraine

Location

CNE of Lviv Reg Council Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU

Lviv, 79010, Ukraine

Location

CNE City Clinical Hospital #5 of Lviv

Lviv, 79013, Ukraine

Location

CNE Odesa Regional Clinical Hospital of Odesa Regional Council

Odesa, 65025, Ukraine

Location

Medical Center of Limited Liability Company Health Clinic, Medical Clinical Research Center

Vinnytsia, 21009, Ukraine

Location

Medical Center of Limited Liability Company Medical Center Saliutem

Vinnytsia, 21050, Ukraine

Location

Municipal Non-profit Enterprise "City Hospital No.6" of Zaporizhzya City Council

Zaporizhzhia, 69035, Ukraine

Location

CNE Zaporizhzhia RCH of ZRC Dept of Neurology #1

Zaporizhzhia, 69600, Ukraine

Location

CNE Zaporizhzhia Regional Clinical Hospital of ZRC

Zaporizhzhia, 69600, Ukraine

Location

Medical Center of Limited Liability Company INET-09

Zaporizhzhya, 69035, Ukraine

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

orelabrutinib

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 15, 2021
• Study Start: March 1, 2021
• Primary Completion: February 25, 2026
• Study Completion: March 1, 2026
• Last Updated: April 21, 2023

Record last verified: 2023-03

Locations

US (5); UA (17); CN (13); PL (7)