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NCT07299019 · ClinicalTrials.gov registry record · Phase 3

A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

A Phase 3 study of Secondary Progressive Multiple Sclerosis, sponsored by Zenas BioPharma (USA).

Recruiting
Registry status
Phase 3
Development phase
990
Enrollment target
1
Study location

NCT07299019 is a Phase 3 study of Secondary Progressive Multiple Sclerosis that is actively recruiting participants, run by Zenas BioPharma (USA). The registered enrollment target is 990 participants, above the 373-participant average among 8 other Secondary Progressive Multiple Sclerosis trials with a reported enrollment target (165% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT07299019, a Phase 3 study of Secondary Progressive Multiple Sclerosis, is actively recruiting participants, sponsored by Zenas BioPharma (USA).

RECRUITING
Registry status
Phase 3
Development phase
990 participants
Enrollment target
1
Study location

Study Summary

Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.

Interventions

  • DRUG Placebo
  • DRUG Orelabrutinib

Study Locations (1)

Florida

  • Neurology Associates - Maitland

Trial Details

FieldValue
Enrollment Target 990 participants
Start Date 2026-03
Est. Completion 2030-07
Phase Phase 3

Sponsor

Zenas BioPharma (USA)

5 total trials

What the Registry Record Tells You About NCT07299019

The ClinicalTrials.gov registry entry for NCT07299019 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 990 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 373-participant average among 8 other Secondary Progressive Multiple Sclerosis trials with a reported enrollment target (165% higher). The listed sponsor is Zenas BioPharma (USA), which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Secondary Progressive Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT07299019 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT07299019 about?

NCT07299019 is a clinical study titled "A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis". Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 ...

What is the current status of trial NCT07299019?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 990 participants. The study started on 2026-03. Estimated completion is 2030-07.

What conditions does trial NCT07299019 study?

This clinical trial studies the following conditions: Secondary Progressive Multiple Sclerosis.

What interventions are being tested in trial NCT07299019?

The interventions under investigation include: Placebo (DRUG), Orelabrutinib (DRUG).

Who is sponsoring clinical trial NCT07299019?

This trial is sponsored by Zenas BioPharma (USA), which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07299019 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.