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

Relapsing Remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04711148
• Other study ID #: ICP-CL-00112
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

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