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COMPLETED Phase 3

An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

NCT03669588 · View on ClinicalTrials.gov ↗

Study Summary

A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL ARGX-113

Study Locations (20)

California

  • Investigator Site 66 — Carlsbad
  • Investigator Site 5 — Los Angeles
  • Investigator Site 49 — Los Angeles
  • Investigator Site 18 — Orange
  • Investigator Site 40 — Palo Alto
  • Investigator Site 59 — San Francisco

Florida

  • Investigator Site 34 — Jacksonville
  • Investigator Site 4 — Tampa

Arizona

  • Investigator Site 29 — Phoenix

Colorado

  • Investigator Site 58 — Aurora

Illinois

  • Investigator Site 30 — Springfield

Iowa

  • Investigator Site 25 — Iowa City

Kansas

  • Investigator Site 21 — Kansas City

Massachusetts

  • Investigator Site 27 — Boston

Trial Details

FieldValue
Enrollment Target 167 participants
Start Date 2018-08-22
Est. Completion 2020-04-06
Phase Phase 3

Sponsor

argenx

96 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03669588

The ClinicalTrials.gov registry entry for NCT03669588 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 167 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 96 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03669588 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03669588 about?

NCT03669588 is a clinical study titled "An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness". A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.

What is the current status of trial NCT03669588?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 167 participants. The study started on 2018-08-22. Estimated completion is 2020-04-06.

What conditions does trial NCT03669588 study?

This clinical trial studies the following conditions: Generalized Myasthenia Gravis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03669588?

The interventions under investigation include: Placebo (BIOLOGICAL), ARGX-113 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03669588?

This trial is sponsored by argenx, which has 96 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03669588 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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