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Monoclonal Antibodies
Donidalorsen for Hereditary Angioedema
Phase 3
Recruiting
Research Sponsored by Ionis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have access to, and the ability to use, ≥ 1 acute medication(s) (e.g., plasma-derived or recombinant C1-INH concentrate or a bradykinin receptor (BK) 2-receptor antagonist) to treat angioedema attacks.
Participants must have a documented diagnosis of HAE-1/HAE-2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 70 weeks, plus 104 weeks for group 1; up to approximately 76 weeks, plus 104 weeks for group 2
Awards & highlights
Study Summary
This trial will study the long-term effects of donidalorsen in people with HAE. It will look at the number of HAE attacks and how donidalorsen affects quality of life.
Who is the study for?
This trial is for individuals aged 12 or older with a confirmed diagnosis of Hereditary Angioedema (HAE) types 1 or 2. They must have completed a previous study through Week 25, be on stable HAE prophylaxis treatment, and able to manage acute attacks. Excluded are those with recent malignancies, certain medication exposures, hypersensitivity to donidalorsen, other angioedema types, drug/alcohol abuse history.Check my eligibility
What is being tested?
The trial studies the long-term safety and effectiveness of donidalorsen in preventing HAE attacks. It aims to understand how this intervention affects the frequency of attacks and quality of life over an extended period for people living with HAE.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to long-term use of donidalorsen. Potential side effects may include reactions at injection sites or allergic responses if sensitivity to the drug exists.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can access and use medication for sudden swelling attacks.
Select...
I have been diagnosed with hereditary angioedema type 1 or 2.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 70 weeks, plus 104 weeks for group 1; up to approximately 76 weeks, plus 104 weeks for group 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 70 weeks, plus 104 weeks for group 1; up to approximately 76 weeks, plus 104 weeks for group 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with at Least One Treatment-emergent Adverse Event (TEAE), Graded by Severity
Secondary outcome measures
Angioedema Quality of Life (AE-QoL) Questionnaire Total Score
Number of Investigator-confirmed HAE Attacks Requiring Acute Therapy
Percentage of Investigator-confirmed HAE Attack-free Participants
+2 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
1Treatment groups
Experimental Treatment
Group I: OLE ParticipantsExperimental Treatment1 Intervention
Group 1 and Group 2 participants will be administered donidalorsen by SC injection for up to 157 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
15,138 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been in a previous study for donidalorsen.I can access and use medication for sudden swelling attacks.You have had problems with drugs or alcohol in the recent past or are currently using them.I have taken ACE inhibitors or estrogen medications.I haven't taken any experimental drugs or biological treatments recently.I have been diagnosed with hereditary angioedema type 1 or 2.I plan to change my current medication to prevent swelling attacks.I have a new or worsening health condition, or a change in my medication.I haven't had cancer in the last 5 years, except for certain skin, cervical, breast, or prostate cancers.You have any important abnormal results in your screening blood tests.I haven't taken any oligonucleotide medications in the last 4 to 12 months.You are allergic to the main ingredient (donidalorsen) or any other ingredients in the treatment.I have been diagnosed with a type of recurrent swelling not caused by HAE Type I/II.I have been on a stable dose of my preventive medication for at least 12 weeks.I am 12 years old or older.You have completed a specific study and have shown good safety and tolerability.
Research Study Groups:
This trial has the following groups:- Group 1: OLE Participants
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Has the FDA cleared Donidalorsen for patient use?
"There is both supporting clinical data and multiple rounds of safety testing, so Donidalorsen was given a 3."
Answered by AI
Are there any patients still being recruited for this test?
"The trial, whose most recent update was on 11/3/2022, is still recruiting patients according to the information published on clinicaltrials.gov."
Answered by AI
Where can I find a list of sites where I can participate in this research?
"Currently, there are 14 clinical trial sites operational. The locations include Walnut Creek, Columbus, Paradise Valley and 11 other cities. If you are considering participating in this study, please choose the site that is closest to your location to minimize travel requirements."
Answered by AI
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