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A Study of Rocbrutinib in PRL-Positive Relapsing-Remitting Multiple Sclerosis

NCT07776743 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-20

No results posted yet for this study

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). 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.

Conditions

  • Relapsing-remitting Multiple Sclerosis (RRMS)

Interventions

DRUG

Rocbrutinib

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).

DRUG

Dimethyl Fumarate

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.

Sponsors & Collaborators

  • Guangzhou Lupeng Pharmaceutical Company LTD.

    lead INDUSTRY

Principal Investigators

  • De-Cai Tian, M.D., Ph.D. · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-06-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07776743 on ClinicalTrials.gov