A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis
A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis
This is a randomized, double-Blind, placebo-controlled Phase 2 Study of Orelabrutinib in
 Patients with Relapsing-Remitting Multiple Sclerosis.
This study is conducted to evaluate efficacy, safety, tolerability, pharmacokinetics, and
 biological activity. Patients with RRMS will be randomly assigned to 1 of 4 treatment groups.
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

 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.