Relapsing Remitting Multiple SclerosisPhase 2NCT04711148
A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis
A Phase 2 study testing orelabrutinib in people with Relapsing Remitting Multiple Sclerosis, run by Beijing InnoCare Pharma Tech Co., Ltd. at 42 sites in 4 countries.
Trial summary
This is a randomized, double-Blind, placebo-controlled Phase 2 Study of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- orelabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 42 sitesin 4 countries
- Study dates
- 1 Mar 2021to 1 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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,
Show all 16Show fewer
- 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)
Trial locations and contacts
42 sites in 4 countries.
42 sites in 4 countries
Ukraine17 sites
CE I.I.Mechnykov Dnipropetrovsk RC Hosp of Dnipropetrovsk RC Dept of Neurology
Dnipro, 49005
Medical Center of Dnipro State Medical University, Dnipro State Medical University
Dnipro, 49027
SI USSRI of Medical and Social Problems of Disabilities of MOHU
Dnipro, 49027
CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council
Ivano-Frankivsk, 76008
Institute of Neurology, Psychiatry and Narcology of NAMSU
Kharkiv, 61068
SI Institute of Neurology, Psychiatry and Narcology of NAMSU
Kharkiv, 61068
CIH Kharkiv City General Practice
Kharkiv, 61172
Medical Center of Limited Liability Company Medbud-Clinic
Kyiv, 3110
CNE of Lviv Reg Council Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU
Lviv, 79010
CNE City Clinical Hospital #5 of Lviv
Lviv, 79013
CNE Odesa Regional Clinical Hospital of Odesa Regional Council
Odesa, 65025
Medical Center of Limited Liability Company Health Clinic, Medical Clinical Research Center
Vinnytsia, 21009
Medical Center of Limited Liability Company Medical Center Saliutem
Vinnytsia, 21050
Medical Center of Limited Liability Company INET-09
Zaporizhzhya, 69035
Municipal Non-profit Enterprise "City Hospital No.6" of Zaporizhzya City Council
Zaporizhzhya, 69035
CNE Zaporizhzhia RCH of ZRC Dept of Neurology #1
Zaporizhzhya, 69600
CNE Zaporizhzhia Regional Clinical Hospital of ZRC
Zaporizhzhya, 69600
China13 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
The First Hospital of Jilin University
Changchun, Jilin, 130021
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Shengjing Hospital of China Medical University
Shengyang, Liaoning, 110004
The 1st Affiliated Hospital of Shanxi Medical University
Taiyuan, Shan'xi
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430060
The Second Affiliated Hospital of Air Force Military Medical University
Xi’an, Shanxi, 710038
The First Affiliated Hospital of Chongqing Medical University
Yuzhong, Chongqing Municipality, 400016
Poland7 sites
NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"
Katowice, 40-123
Prywatna Praktyka Lekarska
Katowice, 40-571
Resmedica NZOZ Kielce
Kielce, 25-726
MCD Medical
Krakow, 31-637
Neuromed
Lublin, 20-954
Nzoz "Neuro-Kard"
Poznan, 61-853
Wielospecjalistyczne Centrum Medyczne Ibismed
Zabrze, 41-807
United States5 sites
Premier Neurology, P.C.
Greer, South Carolina, 29650
Neurology Associates, P.C.
Lincoln, Nebraska, 68510
Consultants in Neurology LTD
Northbrook, Illinois, 60062
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174
University of South Florida
Tampa, Florida, 33612
About this study
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
This is a randomized, double-Blind, placebo-controlled Phase 2 Study of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis.
Read the 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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- placebo, orelabrutinib
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
placebo
orelabrutinibDrug
Orelabrutinib is a white, round, uncoated tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: orelabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 120 weeks
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability ]
To evaluate the safety and tolerability of orelabrutinib compared to placebo in the Core Part
Measured: up to 120 weeks
ARR[efficacy]
Annualized relapse rate in the OLE Part
Measured: up to 120 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Mar 2021
- Primary completion25 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711148
- Sponsor's protocol ID
- ICP-CL-00112
- Status last verified
- Mar 2023
- First submitted
- 8 Jan 2021
- Last updated
- 21 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04711148
- Acronym / sponsor ID
- ICP-CL-00112
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 25 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: placebo, Drug: orelabrutinibThe 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. |
| orelabrutinib(low dose) | Experimental | Drug: orelabrutinibThe 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. |
| orelabrutinib(medium dose) | Experimental | Drug: orelabrutinibThe 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. |
| orelabrutinib (high dose) | Experimental | Drug: orelabrutinibThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboplacebo | Other | placebo |
| orelabrutinibOrelabrutinib is a white, round, uncoated tablet | Drug | orelabrutinib (high dose), orelabrutinib(low dose), orelabrutinib(medium dose), placebo |
Primary outcome
The cumulative number of new GdE T1 MRI brain lesions
Time frame: up to 120 weeks
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.
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability ]
Time frame: up to 120 weeks
ARR[efficacy]
Time frame: up to 120 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing orelabrutinib in people with Relapsing Remitting Multiple Sclerosis, run by Beijing InnoCare Pharma Tech Co., Ltd. at 42 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Ukraine, China, Poland, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cumulative number of new GdE T1 MRI brain lesions (time frame: up to 120 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.