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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Relapsing Remitting Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT04711148

Run by

Beijing InnoCare Pharma Tech Co., Ltd.

People needed

160

Starts

2021-03-01

Expected to finish

2026-03-01

Last updated by the study team

2023-04-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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.
• 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)

Where it is running

• Neurology Associates of Ormond Beach — Ormond Beach, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Consultants in Neurology LTD — Northbrook, Illinois, United States
• Neurology Associates, P.C. — Lincoln, Nebraska, United States
• Premier Neurology, P.C. — Greer, South Carolina, United States
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Chongqing Medical University — Yuzhong, Chongqing Municipality, China
• Tongji Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China
• Xiangya Hospital, Central South University — Changsha, Hunan, China
• The First Hospital of Jilin University — Changchun, Jilin, China
• Shengjing Hospital of China Medical University — Shengyang, Liaoning, China
• The 1st Affiliated Hospital of Shanxi Medical University — Taiyuan, Shan'xi, China
• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China
• The Second Affiliated Hospital of Air Force Military Medical University — Xi’an, Shanxi, China
• West China Hospital, Sichuan University — Chengdu, Sichuan, China
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• 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, Poland

Full record on ClinicalTrials.gov

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