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NCT03315130 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis

A Phase 2 study of Generalized Myasthenia Gravis, sponsored by Ra Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
45
Enrollment target
20
Study locations

NCT03315130 is a Phase 2 study of Generalized Myasthenia Gravis that has completed, run by Ra Pharmaceuticals. The registered enrollment target is 45 participants, below the 129-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT03315130, a Phase 2 study of Generalized Myasthenia Gravis, has completed, sponsored by Ra Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
45 participants
Enrollment target
20
Study locations

Study Summary

The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.

Conditions Studied

Generalized Myasthenia Gravis

Interventions

  • DRUG Placebo
  • DRUG zilucoplan (RA101495)

Study Locations (20)

California

  • The Research Center of Southern California - Carlsbad
  • UCLA Medical Center - Los Angeles
  • University of California Irvine Health ALS and Neuromuscular Center - Orange

New York

  • University of Buffalo - Buffalo
  • Hospital for Special Surgery - New York
  • Mount Sinai Hospital - New York

Florida

  • University of Florida - Jacksonville
  • University of South Florida - Tampa

Massachusetts

  • Massachusetts General Hospital - Boston
  • Lahey Hospital and Medical Center - Burlington

Michigan

  • Wayne State University - Detroit
  • Michigan State University - East Lansing

Alabama

  • Diagnostic and Medical Clinic - Mobile - Mobile

Connecticut

  • Yale University - New Haven

District of Columbia

  • George Washington University - Washington D.C.

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2017-10-11
Est. Completion 2020-11-19
Phase Phase 2

Sponsor

Ra Pharmaceuticals

5 total trials

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What the Registry Record Tells You About NCT03315130

The ClinicalTrials.gov registry entry for NCT03315130 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 129-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (65% lower). The listed sponsor is Ra Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03315130 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, New York, Florida.

Frequently Asked Questions

What is clinical trial NCT03315130 about?

NCT03315130 is a clinical study titled "Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis". The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.

What is the current status of trial NCT03315130?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2017-10-11. Estimated completion is 2020-11-19.

What conditions does trial NCT03315130 study?

This clinical trial studies the following conditions: Generalized Myasthenia Gravis.

What interventions are being tested in trial NCT03315130?

The interventions under investigation include: Placebo (DRUG), zilucoplan (RA101495) (DRUG).

Who is sponsoring clinical trial NCT03315130?

This trial is sponsored by Ra Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03315130 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, 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.