Relapsing-remitting Multiple Sclerosis (RRMS)Phase 2NCT07776743
A Study of Rocbrutinib in PRL-Positive Relapsing-Remitting Multiple Sclerosis
A Phase 2 study testing Rocbrutinib and Dimethyl Fumarate in people with Relapsing-remitting Multiple Sclerosis (RRMS), run by Guangzhou Lupeng Pharmaceutical Company LTD. at 1 site in China.
Trial summary
This is a randomized, controlled, multicenter, open-label Phase IIa clinical study to evaluate the efficacy and safety of rocbrutinib (LP-168), an oral BTK inhibitor, in subjects with paramagnetic rim lesion (PRL)-positive relapsing-remitting multiple sclerosis (RRMS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis (RRMS)
- What is being tested?
- Rocbrutinib and Dimethyl Fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years (inclusive), male or female.
- Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the 2017 revised McDonald criteria.
- Disease activity, meeting at least one of the following: (a) at least 2 documented relapses within 2 years, or at least 1 relapse within 1 year prior to signing the ICF; OR (b) at least 1 T1 gadolinium-enhancing (Gd+) lesion confirmed by brain MRI within 180 days prior to signing the ICF.
- Measurable lesions: at least 4 paramagnetic rim lesions (PRL) in the CNS observed by 7T MRI within 4 weeks prior to randomization.
- Concomitant medication: subjects with RRMS may receive stable-dose dimethyl fumarate (DMF); other treatments require discontinuation and washout (see Exclusion Criterion #13).
- EDSS score ≥0 and ≤5.5 at screening and baseline assessments prior to randomization.
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- Neurological status stable for at least 30 days prior to randomization.
- Adequate hepatic and renal function: AST and ALT ≤2.0 × ULN; serum total bilirubin ≤1.2 × ULN (≤3.0 × ULN if documented Gilbert's syndrome); serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula).
- All male subjects and female subjects of childbearing potential must use medically acceptable contraception throughout the treatment period and for 1 week after the last dose; female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before start of treatment and must not be lactating; male subjects must not donate sperm during the study and for 1 week after the last dose.
- Willing and able to provide written informed consent and to comply with the study treatment schedule and visit plan.
Who cannot join
- Subjects with a disease duration of RRMS >10 years and an EDSS score ≤2.
- Neurological or autoimmune diseases other than RRMS that, in the investigator's judgment, may affect efficacy evaluation due to clinical symptoms or concomitant medication.
- Contraindications to MRI or allergy to gadolinium-based contrast agents.
- Currently diagnosed with or suspected of progressive multifocal leukoencephalopathy (PML), or a history of PML.
- History of malignancy within 2 years prior to randomization, except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, localized squamous cell carcinoma, and malignancies confirmed by the investigator to have been cured by surgery or other treatments.
- History of serious infection or potential risk of serious infection, including: HIV infection; syphilis or tuberculosis infection (except previously infected subjects judged cured by the investigator or specialist); HBsAg- or HBcAb-positive with HBV-DNA above the upper limit of normal of the study site (subjects with HBsAg- or HBcAb-positive but HBV-DNA negative may be enrolled and require anti-HBV therapy during the study); HCV antibody-positive with HCV-RNA above the ULN or qualitatively positive (HCV-RNA-negative subjects may be enrolled).
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- Prior organ, allogeneic stem cell or bone marrow transplantation and/or anti-rejection therapy.
- Systemic chronic, recurrent or serious infection within 90 days prior to randomization (e.g., pneumonia, sepsis).
- Uncontrolled active systemic bacterial, fungal or viral infection within 4 weeks prior to randomization.
- Receipt of live attenuated vaccines within 4 weeks prior to randomization, or planned during the study or within 4 weeks after the end of study treatment.
- Prior treatment with BTK inhibitors for malignant or autoimmune indications.
- Any other medical condition or complication that adversely affects participation in the study, including but not limited to: short expected survival due to pre-existing health conditions; inability to undergo primary efficacy endpoint evaluation; severe and/or uncontrolled systemic diseases judged unsuitable for the study by the investigator (including uncontrolled hypertension or diabetes ≥CTCAE Grade 2, unstable angina, congestive heart failure, respiratory diseases requiring continuous oxygen, severe thromboembolism, uncontrolled major bleeding or bleeding from vital organs, known platelet dysfunction, severe hepatic/renal or metabolic diseases such as cirrhosis or renal failure).
- Poor cardiac function: NYHA class ≥2, or LVEF <50% by echocardiography, or significant abnormalities on screening ECG (atrial fibrillation/flutter, second-degree type II or third-degree atrioventricular block, CTCAE ≥Grade 2 bradycardia, or mean QTcF ≥450 ms on ≥3 independent ECGs).
- History of cerebral infarction or intracranial hemorrhage (except lacunar infarction judged by the investigator as not affecting enrollment).
- History of myocardial infarction within 180 days.
- Receipt of any investigational drug within 3 months or 5 half-lives (whichever is longer) prior to randomization.
- Receipt of the following MS treatments within the specified periods prior to randomization: systemic corticosteroids within 4 weeks; intravenous immunoglobulin or S1P receptor modulators (e.g., fingolimod) within 2 months; azathioprine, mycophenolate mofetil or methotrexate within 3 months; anti-CD20 monoclonal antibodies (e.g., ofatumumab, ocrelizumab, rituximab) within 6 months, or if the last dose was >6 months before screening but peripheral blood B cells have not recovered to normal levels; teriflunomide within 6 months (washout may be shortened to 1 month if plasma teriflunomide concentration <0.02 mg/L after rapid clearance); anti-α4-integrin antibody (natalizumab) within 6 months; anti-CD52 antibody (alemtuzumab) within 4 years; prior total lymphoid irradiation, mitoxantrone (with cardiotoxicity or cumulative dose ≥120 mg/m²), or other potent immunosuppressive therapy with long-lasting effects.
- Major surgery (usually defined as Grade III or above per institutional regulations) or serious trauma within 4 weeks prior to randomization.
- Planned long-term use during the study of: strong or moderate CYP3A inhibitors or inducers, OATP1B3 sensitive substrates, or proton pump inhibitors (see Appendices 2 and 3).
- Receipt of anticoagulants or antiplatelet agents within 7 days or 5 half-lives (whichever is longer) prior to randomization.
- Conditions affecting the ability to swallow the drug, or conditions seriously affecting drug absorption or pharmacokinetics (e.g., refractory nausea/vomiting, short bowel syndrome).
- Disease symptoms unfavorable for oral administration of the study drug; unresolved toxicity from prior treatment affecting AE assessment; underlying disease leading to poor compliance; or alcohol/drug abuse or dependence.
- Hypersensitivity to rocbrutinib tablets/dimethyl fumarate capsules or any of their excipients.
- Any other condition judged by the investigator as unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality
De-Cai Tian, M.D., Ph.D., +861059978585, tiandecai@bjtth.org
About this study
Official title: A Phase IIa Clinical Study to Evaluate the Efficacy and Safety of Rocbrutinib (LP-168), an Oral BTK Inhibitor, in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)
This is a randomized, controlled, multicenter, open-label Phase IIa clinical study to evaluate the efficacy and safety of rocbrutinib (LP-168), an oral BTK inhibitor, in subjects with paramagnetic rim lesion (PRL)-positive relapsing-remitting multiple sclerosis (RRMS). Approximately 30 subjects with RRMS will be enrolled and randomized 2:1 to receive rocbrutinib 25 mg once daily (experimental arm) or dimethyl fumarate (DMF) delayed-release capsules 120 mg twice daily, escalated to 240 mg twice daily after 7 days (active control arm). The treatment period is 24 weeks; subjects in the experimental arm who remain relapse-free and are assessed by the investigator as having potential benefit may enter an open-label extension and continue rocbrutinib until Week 48 after randomization. The primary endpoint is the change from screening/baseline in the number, new number, and volume of PRL lesions detected by 7T MRI at Week 24.
- Being tested
- Rocbrutinib, Dimethyl Fumarate
- Keywords
- multiple sclerosis, rocbrutinib, BTK inhibitor, paramagnetic rim lesions, dimethyl fumarate
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocbrutinibDrug
Also called LP-168
Rocbrutinib (LP-168), a novel oral BTK inhibitor, film-coated tablet. Administered 25 mg orally once daily until completion of the treatment period (maximum 48 weeks including open-label extension).
Dimethyl FumarateDrug
DMF delayed-release capsules 120 mg/240 mg. Starting dose 120 mg twice daily; after 7 days, increase to maintenance dose 240 mg twice daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rocbrutinib | Experimental | Rocbrutinib tablet orally once daily, taken on an empty stomach (except 1 h before to 2 h after meals) with approximately 240 mL of water; tablets must be swallowed whole. Continue until the end of the treatment period; subjects without relapse and with potential benefit may enter the open-label extension through Week 48. Receives: Drug: Rocbrutinib |
| Dimethyl Fumarate (DMF) | Active comparator | DMF 120 mg orally twice daily as starting dose; after 7 days, escalate to maintenance dose 240 mg twice daily for 24 weeks. May be taken with food to reduce flushing. Receives: Drug: Dimethyl Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Screening/Baseline in the Number, New Number of Paramagnetic Rim Lesions (PRL) Detected by 7T MRI
7T MRI imaging performed at screening/baseline and Week 24 to assess the number, newly appearing number, and volume of PRL lesions.Newly developed PRLs are defined as either (1) newly appearing lesions that demonstrate a paramagnetic rim, or (2) pre-existing lesions without a paramagnetic rim at baseline that develop a new paramagnetic rim during follow-up.
Measured: From screening/baseline to Week 24
Change from Screening/Baseline in the Volume of Paramagnetic Rim Lesions (PRL) Detected by 7T MRI
7T MRI imaging performed at screening/baseline and Week 24 to assess the Volume
Measured: From screening/baseline to Week 24
Secondary outcomes (14)
Change from Screening/Baseline in number, newly occured number of PRL lesions at Weeks 12, 36, and 48 by 7T MRI
Measured: Weeks 12, 36, and 48
Change from Screening/Baseline in Volume of PRL lesions at Week 12, 36, and 48 by 7T MRI
Measured: Time Frame: Weeks 12, 36, and 48
Number of total and newly developed Gd+ T1 lesions at Week 12, 24, 36 and 48 by 3T MRI
Newly developed Gd+ T1 lesions are defined as Gd+ T1 lesions that are newly identified compared with the preceding MRI assessment. Persistent enhancement of the same lesion across consecutive visits will not be counted as a newly developed lesion more than once.
Measured: Weeks 12, 24, 36, and 48
Cumulative number of new/enlarging T2 lesions at Week 12, 24, 36 and 48 by 7T MRI
Measured: Weeks 12, 24, 36, and 48
Change from Screening/Baseline in brain volume at Week 12, 24 ,36 and 48 by 7T MRI
Measured: Weeks 12, 24, 36, and 48
Change in Expanded Disability Status Scale (EDSS) score
The Expanded Disability Status Scale (EDSS) is scored from 0 (normal neurological examination) to 10 (death); higher scores indicate greater disability
Measured: Weeks 12, 24, 36, and 48
Adjusted cumulative annualized relapse rate (ARR)
Measured: From randomization up to Week 48
Change in Timed 25-Foot Walk (T25FW) results
The Timed 25-Foot Walk (T25FW) is a quantitative ambulation test: the time (in seconds) for the subject to walk 25 feet (7.62 meters) as fast as possible, assessing lower limb motor function; an increase from baseline indicates functional worsening
Measured: Weeks 12, 24, 36, and 48
Change in 9-Hole Peg Test (9HPT) results
The 9-Hole Peg Test (9HPT) is a quantitative upper extremity function test: the time (in seconds) for the subject to place 9 pegs into a pegboard and remove them, tested for both dominant and non-dominant hands, assessing fine motor function; an increase from baseline indicates functional worsening
Measured: Weeks 12, 24, 36, and 48
Time to first confirmed disability progression (CDP) event
CDP is defined as a clinically significant increase in EDSS score from baseline confirmed over at least 4 weeks (increase ≥1.5 points from a baseline of 0; ≥1.0 point from a baseline of 0.5 to ≤5.5; ≥0.5 point from a baseline >5.5)
Measured: From date of randomization until the date of first confirmed disability progression, assessed up to Week 48
Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
Measured: From first dose of study treatment through 4 weeks after the end of the 24-week treatment period (or through 4 weeks after the end of the 48-week treatment period including the open-label extension), including the safety follow-up period
Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0
Measured: From first dose of study treatment through 4 weeks after the end of the 24-week treatment period (or through 4 weeks after the end of the 48-week treatment period including the open-label extension), including the safety follow-up period
Number of participants with serious adverse events (SAEs) as assessed by CTCAE v5.0
Measured: From first dose of study treatment through 4 weeks after the end of the 24-week treatment period (or through 4 weeks after the end of the 48-week treatment period including the open-label extension), including the safety follow-up period
Number of participants with clinically significant abnormal findings on physical examination
Measured: From first dose of study treatment through 4 weeks after the end of the 24-week treatment period (or through 4 weeks after the end of the 48-week treatment period including the open-label extension), including the safety follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (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 Sclerosis (RRMS)Studies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- De-Cai Tian, M.D., Ph.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776743
- Sponsor's protocol ID
- LP-168-CN205-MS
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Clinical Study to Evaluate the Efficacy and Safety of Rocbrutinib (LP-168), an Oral BTK Inhibitor, in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)
- ClinicalTrials.gov ID
- NCT07776743
- Acronym / sponsor ID
- LP-168-CN205-MS
- Keywords
- multiple sclerosis, rocbrutinib, BTK inhibitor, paramagnetic rim lesions, dimethyl fumarate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Aug 2026 (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, controlled, multicenter, open-label Phase IIa clinical study to evaluate the efficacy and safety of rocbrutinib (LP-168), an oral BTK inhibitor, in subjects with paramagnetic rim lesion (PRL)-positive relapsing-remitting multiple sclerosis (RRMS). Approximately 30 subjects with RRMS will be enrolled and randomized 2:1 to receive rocbrutinib 25 mg once daily (experimental arm) or dimethyl fumarate (DMF) delayed-release capsules 120 mg twice daily, escalated to 240 mg twice daily after 7 days (active control arm). The treatment period is 24 weeks; subjects in the experimental arm who remain relapse-free and are assessed by the investigator as having potential benefit may enter an open-label extension and continue rocbrutinib until Week 48 after randomization. The primary endpoint is the change from screening/baseline in the number, new number, and volume of PRL lesions detected by 7T MRI at Week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocbrutinib | Experimental | Drug: RocbrutinibRocbrutinib tablet orally once daily, taken on an empty stomach (except 1 h before to 2 h after meals) with approximately 240 mL of water; tablets must be swallowed whole. Continue until the end of the treatment period; subjects without relapse and with potential benefit may enter the open-label extension through Week 48. |
| Dimethyl Fumarate (DMF) | Active comparator | Drug: Dimethyl FumarateDMF 120 mg orally twice daily as starting dose; after 7 days, escalate to maintenance dose 240 mg twice daily for 24 weeks. May be taken with food to reduce flushing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 to 65 years (inclusive), male or female.
- Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the 2017 revised McDonald criteria.
- Disease activity, meeting at least one of the following: (a) at least 2 documented relapses within 2 years, or at least 1 relapse within 1 year prior to signing the ICF; OR (b) at least 1 T1 gadolinium-enhancing (Gd+) lesion confirmed by brain MRI within 180 days prior to signing the ICF.
- Measurable lesions: at least 4 paramagnetic rim lesions (PRL) in the CNS observed by 7T MRI within 4 weeks prior to randomization.
- Concomitant medication: subjects with RRMS may receive stable-dose dimethyl fumarate (DMF); other treatments require discontinuation and washout (see Exclusion Criterion #13).
Key exclusion criteria (24 listed)
- Subjects with a disease duration of RRMS >10 years and an EDSS score ≤2.
- Neurological or autoimmune diseases other than RRMS that, in the investigator's judgment, may affect efficacy evaluation due to clinical symptoms or concomitant medication.
- Contraindications to MRI or allergy to gadolinium-based contrast agents.
- Currently diagnosed with or suspected of progressive multifocal leukoencephalopathy (PML), or a history of PML.
- History of malignancy within 2 years prior to randomization, except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, localized squamous cell carcinoma, and malignancies confirmed by the investigator to have been cured by surgery or other treatments.
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 |
|---|---|---|
| RocbrutinibAlso: LP-168Rocbrutinib (LP-168), a novel oral BTK inhibitor, film-coated tablet. Administered 25 mg orally once daily until completion of the treatment period (maximum 48 weeks including open-label extension). | Drug | Rocbrutinib |
| Dimethyl FumarateDMF delayed-release capsules 120 mg/240 mg. Starting dose 120 mg twice daily; after 7 days, increase to maintenance dose 240 mg twice daily for 24 weeks. | Drug | Dimethyl Fumarate (DMF) |
Primary outcome
Change from Screening/Baseline in the Number, New Number of Paramagnetic Rim Lesions (PRL) Detected by 7T MRI
Time frame: From screening/baseline to Week 24
7T MRI imaging performed at screening/baseline and Week 24 to assess the number, newly appearing number, and volume of PRL lesions.Newly developed PRLs are defined as either (1) newly appearing lesions that demonstrate a paramagnetic rim, or (2) pre-existing lesions without a paramagnetic rim at baseline that develop a new paramagnetic rim during follow-up.
Change from Screening/Baseline in the Volume of Paramagnetic Rim Lesions (PRL) Detected by 7T MRI
Time frame: From screening/baseline to Week 24
7T MRI imaging performed at screening/baseline and Week 24 to assess the Volume
14 secondary outcomes
Change from Screening/Baseline in number, newly occured number of PRL lesions at Weeks 12, 36, and 48 by 7T MRI
Time frame: Weeks 12, 36, and 48
Change from Screening/Baseline in Volume of PRL lesions at Week 12, 36, and 48 by 7T MRI
Time frame: Time Frame: Weeks 12, 36, and 48
Number of total and newly developed Gd+ T1 lesions at Week 12, 24, 36 and 48 by 3T MRI
Time frame: Weeks 12, 24, 36, and 48
Cumulative number of new/enlarging T2 lesions at Week 12, 24, 36 and 48 by 7T MRI
Time frame: Weeks 12, 24, 36, and 48
Change from Screening/Baseline in brain volume at Week 12, 24 ,36 and 48 by 7T MRI
Time frame: Weeks 12, 24, 36, and 48
Change in Expanded Disability Status Scale (EDSS) score
Time frame: Weeks 12, 24, 36, and 48
Adjusted cumulative annualized relapse rate (ARR)
Time frame: From randomization up to Week 48
Change in Timed 25-Foot Walk (T25FW) results
Time frame: Weeks 12, 24, 36, and 48
Change in 9-Hole Peg Test (9HPT) results
Time frame: Weeks 12, 24, 36, and 48
Time to first confirmed disability progression (CDP) event
Time frame: From date of randomization until the date of first confirmed disability progression, assessed up to Week 48
Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
Time frame: From first dose of study treatment through 4 weeks after the end of the 24-week treatment period (or through 4 weeks after the end of the 48-week treatment period including the open-label extension), including the safety follow-up period
Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0
Time frame: From first dose of study treatment through 4 weeks after the end of the 24-week treatment period (or through 4 weeks after the end of the 48-week treatment period including the open-label extension), including the safety follow-up period
Number of participants with serious adverse events (SAEs) as assessed by CTCAE v5.0
Time frame: From first dose of study treatment through 4 weeks after the end of the 24-week treatment period (or through 4 weeks after the end of the 48-week treatment period including the open-label extension), including the safety follow-up period
Number of participants with clinically significant abnormal findings on physical examination
Time frame: From first dose of study treatment through 4 weeks after the end of the 24-week treatment period (or through 4 weeks after the end of the 48-week treatment period including the open-label extension), including the safety follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
De-Cai Tian, M.D., Ph.D. principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rocbrutinib and Dimethyl Fumarate in people with Relapsing-remitting Multiple Sclerosis (RRMS), run by Guangzhou Lupeng Pharmaceutical Company LTD. at 1 site in China.
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 10 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. De-Cai Tian, M.D., Ph.D. (+861059978585, tiandecai@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Screening/Baseline in the Number, New Number of Paramagnetic Rim Lesions (PRL) Detected by 7T MRI (time frame: From screening/baseline to Week 24). The study lists 2 primary outcomes in all. 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 20 Aug 2026.