Table of Contents
- Trial overview
- Hereditary angioedema studies
- Pain study with propofol injection pain
- Trial phases and study design
- Main outcomes being measured
- Who can participate
- What these trials mean for patients
Trial overview
The clinical trials in this set study Icatibant in different research settings.[1] Most trials focus on hereditary angioedema, which is a condition that causes repeated swelling attacks.[1] One trial studies Icatibant in a propofol injection pain model, which means pain caused by an injection of propofol.[3]
Hereditary angioedema studies
Two studies look at Icatibant in people with hereditary angioedema.[1] One Phase 3 study is a placebo-controlled, cross-over trial in adolescents and adults with hereditary angioedema attacks, and it measures how fast symptom relief begins.[1] Another Phase 3 study tests prevention of attacks in adults and adolescents over a 24-week treatment period, using the number of investigator-confirmed attacks as the main result.[4]
The Phase 4 study also focuses on hereditary angioedema and long-term on-demand treatment for acute attacks.[2] This study includes laryngeal attacks, which are swelling attacks in the throat area, but the source says these are without breathing difficulties.[2] Its main goal is safety during longer-term use, not only attack relief.[2]
Pain study with propofol injection pain
One Phase 2 trial studies Icatibant in a pain model called propofol injection pain.[3] This study compares Icatibant with placebo and with other study drugs given by intravenous injection or intravenous administration.[3] The main outcome is the area under the curve of pain scores on a Visual Analog Scale at or above 30 mm, which means researchers are measuring pain over time, not just at one moment.[3]
Trial phases and study design
The studies include Phase 2, Phase 3, and Phase 4 trials.[1][2][3][4]
Phase 2 is used in the pain study to explore whether Icatibant helps with propofol injection pain and to gather early safety and efficacy data.[3]
Phase 3 studies are larger and compare Icatibant-related research questions in hereditary angioedema, including treatment of attacks and prevention of attacks.[1][4]
Phase 4 focuses on long-term safety in hereditary angioedema, including safety checks during ongoing treatment.[2]
The study designs are all interventional, which means the researchers give a treatment and then measure the results.[1][2][3][4]
Main outcomes being measured
In the hereditary angioedema attack study, the main outcome is the time to onset of symptom relief.[1] This is defined as the time until the patient reports being at least “a little better” for two timepoints in a row within 12 hours after treatment.[1]
In the prevention study, the main outcome is the time-normalized number of investigator-confirmed angioedema attacks during 24 weeks.[4] This helps show how often attacks happen while people are in the study.[4]
In the long-term safety study, the main outcomes include adverse events, serious adverse events, treatment-related events, events that lead to stopping treatment, vital signs, clinical laboratory tests, ECG, and physical examination.[2] These measures help researchers watch for safety problems during longer follow-up.[2]
In the pain study, the main outcome is pain measured with the Visual Analog Scale over time.[3] This gives a clearer picture of whether Icatibant changes the amount of pain after propofol injection.[3]
Who can participate
The hereditary angioedema studies include adolescents and adults.[1][4] The long-term safety study also includes people with acute angioedema attacks, including laryngeal attacks without breathing difficulties.[2]
The pain study is not about hereditary angioedema; it is about a pain model in participants who can take part in a propofol injection pain study.[3] The source data do not give full eligibility rules, so the exact entry criteria are not listed here.[1][2][3][4]
What these trials mean for patients
These trials show that Icatibant is being studied in both treatment and prevention settings for hereditary angioedema, plus one pain study.[1][2][3][4] The research asks practical questions such as how fast symptoms improve, how often attacks happen, and how safe treatment is over time.[1][2][4] Together, the studies cover short-term relief, prevention, and longer-term safety in people with hereditary angioedema.[1][2][4]
