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Antisense Oligonucleotide
Donidalorsen for Hereditary Angioedema
Phase 3
Waitlist Available
Research Sponsored by Ionis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 5 to week 25
Awards & highlights
Study Summary
This trial will test a new medication for people with HAE, to see if it is safe and effective. They will also look at how the medication affects the quality and frequency of HAE attacks and how it impacts patients' quality of life.
Who is the study for?
This trial is for people aged 12 or older with a confirmed diagnosis of hereditary angioedema types 1 or 2, who have had at least two attacks during the screening period. They must be able to provide consent and manage their acute attack medications. Exclusions include prior participation in related studies, recent use of certain prophylactic drugs, drug/alcohol abuse, other angioedema diagnoses, significant lab abnormalities, and recent investigational drug treatment.Check my eligibility
What is being tested?
The OASIS-HAE study is testing the safety and effectiveness of Donidalorsen compared to a placebo in individuals with Hereditary Angioedema (HAE). It aims to see how well Donidalorsen can reduce HAE attacks and improve quality of life for patients.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience reactions related to Donidalorsen or placebo administration. Common side effects in trials like this could include injection site reactions, flu-like symptoms, nausea, fatigue or allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 5 to week 25
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 5 to week 25
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time-Normalized Number of Investigator-Confirmed HAE Attacks (per Month) From Week 1 to Week 25
Secondary outcome measures
Change in Angioedema Quality of Life (AE-QoL) Questionnaire Total Score at Week 25
Number of Investigator-Confirmed HAE Attacks Requiring Acute HAE Therapy From Week 5 to Week 25
Number of Participants With a Clinical Response Defined as a ≥ 50%, ≥ 70%, or ≥ 90% Reduction From Baseline (Screening Rate) in Investigator-confirmed HAE Attack Rate Between Week 5 to Week 25
+4 moreSide effects data
From 2021 Phase 2 trial • 23 Patients • NCT0403059814%
Headache
7%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: Donidalorsen 80 mg
Part A: Placebo
Part B: Donidalorsen 80 mg
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Donidalorsen: Cohort BExperimental Treatment1 Intervention
Participants will be administered donidalorsen by subcutaneous (SC) injection for up to 25 weeks.
Group II: Donidalorsen: Cohort AExperimental Treatment1 Intervention
Participants will be administered donidalorsen by subcutaneous (SC) injection for up to 25 weeks.
Group III: Placebo: Cohort APlacebo Group1 Intervention
Participants will be administered donidalorsen-matching placebo by subcutaneous (SC) injection for up to 25 weeks.
Group IV: Placebo: Cohort BPlacebo Group1 Intervention
Participants will be administered donidalorsen-matching placebo by subcutaneous (SC) injection for up to 25 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Donidalorsen
2021
Completed Phase 3
~150
Find a Location
Who is running the clinical trial?
Ionis Pharmaceuticals, Inc.Lead Sponsor
146 Previous Clinical Trials
15,191 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been taking certain medications for a long time before the screening.You have received oligonucleotide medications within the specified time frame, except for vaccines.You have had issues with drugs or alcohol in the past three years or currently.You have a confirmed diagnosis of hereditary angioedema type 1 (HAE-1) or hereditary angioedema type 2 (HAE-2).You have had at least two confirmed HAE attacks during the screening period.You have been diagnosed with a different type of recurrent angioedema.You have taken certain medications like ACE inhibitors or estrogen-containing drugs in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo: Cohort A
- Group 2: Placebo: Cohort B
- Group 3: Donidalorsen: Cohort A
- Group 4: Donidalorsen: Cohort B
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we looking for more participants in this experiment?
"As of today, this clinical trial is still recruiting patients. According to the information on clinicaltrials.gov, the trial was originally posted on December 3rd, 2021 and was last updated on November 3rd, 2022."
Answered by AI
How many individuals are being recruited for this research project?
"That is correct. The listing on clinicaltrials.gov verifies that this study is currently looking for 84 individuals to participate across 30 different sites. This trial was originally posted on December 3rd, 2021 and was last updated November 3rd, 2020."
Answered by AI
Has donidalorsen undergone the FDA's stamp of approval?
"There is some efficacy data and multiple rounds of safety testing, which gives donidalorsen a score of 3."
Answered by AI
Across how many different sites is this trial taking place?
"There are 30 sites currently running this trial, with some locations in Walnut Creek, Murray and Boston. To try and reduce the burden on participants, it is best to select a site nearest you for participation."
Answered by AI
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