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COMPLETED Phase 3

OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)

NCT05139810 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study was to evaluate the safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Donidalorsen

Study Locations (20)

Other

  • Ionis Investigative Site — Brussels
  • Ionis Investigative Site — Brussels
  • Ionis Investigative Site — Edegem
  • Ionis Investigative Site — Sofia
  • Ionis Investigative Site — Sofia

California

  • Ionis Investigative Site — San Diego
  • Ionis Investigative Site — Santa Monica
  • Ionis Investigative Site — Walnut Creek

Ohio

  • Ionis Investigative Site — Columbus
  • Ionis Investigative Site — Toledo

Arizona

  • Ionis Investigative Site — Scottsdale

Colorado

  • Ionis Investigative Site — Colorado Springs

Florida

  • Ionis Investigative Site — Tampa

Kansas

  • Ionis Investigative Site — Kansas City

Massachusetts

  • Ionis Investigative Site — Boston

Trial Details

FieldValue
Enrollment Target 91 participants
Start Date 2021-12-03
Est. Completion 2023-11-09
Phase Phase 3

Sponsor

Ionis Pharmaceuticals

55 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05139810

The ClinicalTrials.gov registry entry for NCT05139810 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 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ionis Pharmaceuticals, which has 55 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 Hereditary Angioedema 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: NCT05139810 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, California, Ohio. 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 NCT05139810 about?

NCT05139810 is a clinical study titled "OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)". The purpose of this study was to evaluate the safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).

What is the current status of trial NCT05139810?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 91 participants. The study started on 2021-12-03. Estimated completion is 2023-11-09.

What conditions does trial NCT05139810 study?

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

What interventions are being tested in trial NCT05139810?

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

Who is sponsoring clinical trial NCT05139810?

This trial is sponsored by Ionis Pharmaceuticals, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05139810 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Kansas. 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