Clinical trial NCT04711148: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: The cumulative number of new GdE T1 MRI brain lesions
timeFrame: up to 120 weeks
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability ]
timeFrame: up to 120 weeks
measure: ARR[efficacy]
timeFrame: up to 120 weeks
Other outcomes:
measure: Peak concentration (Cmax)
timeFrame: up to 120 weeks
Locations:
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Northbrook
country: United States
facility: Consultants in Neurology LTD
state: Illinois
city: Lincoln
country: United States
facility: Neurology Associates, P.C.
state: Nebraska
city: Greer
country: United States
facility: Premier Neurology, P.C.
state: South Carolina
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Yuzhong
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shengyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: The 1st Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Air Force Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Katowice
country: Poland
facility: NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"
city: Katowice
country: Poland
facility: Prywatna Praktyka Lekarska
city: Kielce
country: Poland
facility: Resmedica NZOZ Kielce
city: Krakow
country: Poland
facility: MCD Medical
city: Lublin
country: Poland
facility: Neuromed
city: Poznan
country: Poland
facility: Nzoz "Neuro-Kard"
city: Zabrze
country: Poland
facility: Wielospecjalistyczne Centrum Medyczne Ibismed
city: Dnipro
country: Ukraine
facility: CE I.I.Mechnykov Dnipropetrovsk RC Hosp of Dnipropetrovsk RC Dept of Neurology
city: Dnipro
country: Ukraine
facility: Medical Center of Dnipro State Medical University, Dnipro State Medical University
city: Dnipro
country: Ukraine
facility: SI USSRI of Medical and Social Problems of Disabilities of MOHU
city: Ivano-Frankivsk
country: Ukraine
facility: CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council
city: Kharkiv
country: Ukraine
facility: Institute of Neurology, Psychiatry and Narcology of NAMSU
city: Kharkiv
country: Ukraine
facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU
city: Kharkiv
country: Ukraine
facility: CIH Kharkiv City General Practice
city: Kyiv
country: Ukraine
facility: Medical Center of Limited Liability Company Medbud-Clinic
city: Lviv
country: Ukraine
facility: CNE of Lviv Reg Council Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU
city: Lviv
country: Ukraine
facility: CNE City Clinical Hospital #5 of Lviv
city: Odesa
country: Ukraine
facility: CNE Odesa Regional Clinical Hospital of Odesa Regional Council
city: Vinnytsia
country: Ukraine
facility: Medical Center of Limited Liability Company Health Clinic, Medical Clinical Research Center
city: Vinnytsia
country: Ukraine
facility: Medical Center of Limited Liability Company Medical Center Saliutem
city: Zaporizhzhia
country: Ukraine
facility: Municipal Non-profit Enterprise "City Hospital No.6" of Zaporizhzya City Council
city: Zaporizhzhia
country: Ukraine
facility: CNE Zaporizhzhia RCH of ZRC Dept of Neurology #1
city: Zaporizhzhia
country: Ukraine
facility: CNE Zaporizhzhia Regional Clinical Hospital of ZRC
city: Zaporizhzhya
country: Ukraine
facility: Medical Center of Limited Liability Company INET-09
Study officials:
References: