The Oasis study is a clinical research study sponsored by Ionis Pharmaceuticals,a company developing a potential new therapy for HAE. This study will help researchers learn whether an investigational study drug is safe and effective at reducing or preventing HAE attacks.
What is HAE?
HAE is a rare and potentially life-threatening genetic disease that causes painful swelling attacks in various parts of the body, mainly in the hands, feet, face, throat, and stomach area. Swelling in the airway can restrict breathing and be fatal. A HAE attack may be triggered by emotional trauma or stress; however, an attack often occurs without a known trigger. Attacks can occur without warning and last up to several days if untreated.
About the Study
What is the Oasis Study?
HAE is a rare, potentially life-threatening disease that causes painful swelling attacks, mainly in the hands, feet, face, throat, and stomach area. Swelling in the airway can restrict breathing and be fatal. Attacks can occur without warning and last up to several days. Most cases of HAE are caused by a genetic mutation that affects production of a protein called C1-inhibitor. HAE affects approximately 20,000 people in the U.S. and Europe. There are medicines available to treat and prevent HAE attacks. Researchers are currently looking for new treatment options that might work better or help improve people’s quality of life.
Who can join the Oasis study?
You may qualify for the study if you meet the following requirements:
- You are 12 years of age or older.
- You have been diagnosed with HAE.
- You have access to at least 1 acute medication to treat HAE attacks.
Other requirements will apply.
What can participants of the Oasis study expect?
- The study will last up to 46 weeks (a little less than a year).
- Participants will be randomly assigned to receive an injection of the study drug or placebo every 4 or 8 weeks.
- Participants will attend up to 11 study clinic visits (about 1 every 4 weeks) to receive study health assessments and be monitored by the study healthcare team.
- Study-related health assessments will be provided at no cost. Participants will be reimbursed for costs associated with study visits (e.g., mileage, parking).
About Oasis Plus
This study will help researchers learn if the study drug is safe and effective for people with HAE when given over a long-term period. Participants in Oasis Plus are either:
- Switching over from a different prophylaxis OR
- Continuing on from another donidalorsen study
Who can participate in the Oasis Plus study?
You may qualify for the study if you meet the following requirements:
- You are 12 years of age or older, and diagnosed with HAE Type 1 or Type 2
- You have been on a stable dose of prophylactic medication such as lanadelumab, berotralstat, or a C1-esterase inhibitor to manage HAE for at least 12 weeks (and are looking to switch) OR
- You have already participated in the Oasis Phase 3 study for HAE
- Other requirements will apply.
What can participants in the Oasis Plus study expect?
- The study will last up to 3 years.
- There is no placebo – everyone enrolled receives active study drug.
- Participants will receive an injection of the study drug every 4 weeks or 8 weeks depending on symptoms.
- Study-related health assessments will be provided at no cost. Participants will be reimbursed for costs associated with study visits (e.g., air travel, mileage, parking).
About the Study Drug
What is the Donidalorsen?
The study drug is called donidalorsen (don-id-a-lor-sen). Donidalorsen is designed to lower the amount of a protein called prekallikrein (PKK) in the body. By lowering PKK, donidalorsen may help reduce or prevent HAE attacks.
Donidalorsen is an injection that is administered under the skin of the upper arm, abdomen, or thigh.
Find a Study Location
For location information or questions, please contact us at [email protected] or 844-501-0233.
51 Study Locations
United States
Belgium
Bulgaria
Canada
France
Italy
Spain
United Kingdom
Germany
Netherlands
Denmark
Israel
Turkey
Poland
Study Locations Map:
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