In short
Clinical trials investigating Icatibant are studying different uses in patients with hereditary angioedema and pain. These trials look at safety, effectiveness, and how quickly symptoms improve in adults and adolescents. Some studies compare Icatibant with placebo or other treatments.
Key points
- Icatibant is being studied in clinical trials for hereditary angioedema and for propofol injection pain. The hereditary angioedema studies include adolescents and adults and test both treatment of attacks and prevention of attacks. The trials cover Phase 2, Phase 3, and Phase 4 research, so they look at both effectiveness and longer-term safety. One study also tests Icatibant in a pain model, comparing it with placebo. The main outcomes include symptom relief, number of attacks, pain scores, and safety checks such as lab tests and ECG.
Trial overview
The clinical trials in this set study Icatibant in different research settings. Most trials focus on hereditary angioedema, which is a condition that causes repeated swelling attacks. One trial studies Icatibant in a propofol injection pain model, which means pain caused by an injection of propofol.
Hereditary angioedema studies
Two studies look at Icatibant in people with hereditary angioedema. 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. 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.
The Phase 4 study also focuses on hereditary angioedema and long-term on-demand treatment for acute attacks. This study includes laryngeal attacks, which are swelling attacks in the throat area, but the source says these are without breathing difficulties. Its main goal is safety during longer-term use, not only attack relief.
Pain study with propofol injection pain
One Phase 2 trial studies Icatibant in a pain model called propofol injection pain. This study compares Icatibant with placebo and with other study drugs given by intravenous injection or intravenous administration. 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.
Trial phases and study design
The studies include Phase 2, Phase 3, and Phase 4 trials.
- 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.
- Phase 3 studies are larger and compare Icatibant-related research questions in hereditary angioedema, including treatment of attacks and prevention of attacks.
- Phase 4 focuses on long-term safety in hereditary angioedema, including safety checks during ongoing treatment.
The study designs are all interventional, which means the researchers give a treatment and then measure the results.
Main outcomes being measured
In the hereditary angioedema attack study, the main outcome is the time to onset of symptom relief. 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.
In the prevention study, the main outcome is the time-normalized number of investigator-confirmed angioedema attacks during 24 weeks. This helps show how often attacks happen while people are in the study.
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. These measures help researchers watch for safety problems during longer follow-up.
In the pain study, the main outcome is pain measured with the Visual Analog Scale over time. This gives a clearer picture of whether Icatibant changes the amount of pain after propofol injection.
Who can participate
The hereditary angioedema studies include adolescents and adults. The long-term safety study also includes people with acute angioedema attacks, including laryngeal attacks without breathing difficulties.
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. The source data do not give full eligibility rules, so the exact entry criteria are not listed here.
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. The research asks practical questions such as how fast symptoms improve, how often attacks happen, and how safe treatment is over time. Together, the studies cover short-term relief, prevention, and longer-term safety in people with hereditary angioedema.