In short
KT-621 is an investigational chemical substance developed by Kymera Therapeutics, Inc., currently studied as an oral tablet for moderate to severe atopic dermatitis and uncontrolled moderate to severe eosinophilic asthma. According to EU Clinical Trials Information System (CTIS) records, three Phase 2 trials of KT-621 are authorised, with planned enrollment ranging from 200 to 264 participants across the studies.
Key points
- KT-621 is an investigational oral tablet with no marketing authorisation in the product records.
- Three Phase 2 trials of KT-621 are authorised in the EU Clinical Trials Information System.
- The trials study moderate to severe atopic dermatitis and uncontrolled moderate to severe eosinophilic asthma.
- The atopic dermatitis trial plans to enroll 200 participants and measure the change in EASI score at Week 16.
- The eosinophilic asthma trial plans to enroll 264 participants and measure the change in pre-bronchodilator FEV1 at Week 12.
- A long-term asthma study plans to enroll 228 participants and follows safety outcomes through Week 52.
What is KT-621?
KT-621 is an investigational chemical substance developed by Kymera Therapeutics, Inc. It is classified as a chemical substance in the CTIS product records, meaning it is a small-molecule chemical compound rather than a protein-based medicine. KT-621 has no marketing authorisation in the product records and remains an investigational substance. The substance appears only under the name KT-621 in the registry.
How does KT-621 work?
The available registry records and supplementary sources do not describe the molecular target or mechanism of action of KT-621. The substance is being studied in diseases of the skin and connective tissue as well as immune system diseases, according to the therapeutic area classification in the CTIS product records. The clinical trials evaluate whether KT-621 can reduce the signs and symptoms of atopic dermatitis and eosinophilic asthma, but the biological pathway through which it may act is not stated in the provided sources.
Which conditions is KT-621 being studied for?
- Moderate to severe atopic dermatitis — a chronic inflammatory skin condition that causes itchy, red, and swollen skin.
- Uncontrolled moderate to severe eosinophilic asthma — a type of asthma characterised by high levels of eosinophils, a kind of white blood cell involved in allergic inflammation.
How is KT-621 given?
KT-621 is given as a tablet for oral use. The CTIS product records list the pharmaceutical form as tablet and the route of administration as oral use. The intervention descriptions in the trials also refer to KT-621 administered orally. The doses used in the trials are not reported in the registry records, as the dose fields show 00 mg or 0 mg, meaning the dose was not stated.
What do the clinical trials show?
Three Phase 2 trials of KT-621 are authorised in the EU Clinical Trials Information System. All three are interventional studies, and all are currently in the authorised status, meaning they have been approved but their results are not yet available in the registry.
Which conditions are studied in the trials?
One trial studies KT-621 in participants with moderate to severe atopic dermatitis. Two trials study KT-621 in participants with uncontrolled moderate to severe eosinophilic asthma. The atopic dermatitis trial is also described in a supplementary source as a Phase 2b, randomised, double-blind, placebo-controlled, parallel-group, multicentre, dose-ranging study with an open-label period.
What phases and status do the trials have?
All three trials are Phase 2 studies. The atopic dermatitis trial is described in the supplementary source as a Phase 2b study, which is a later stage within Phase 2, with a status of active, no longer recruiting according to that source. The CTIS records list all three trials as authorised.
What are the trials measuring?
The atopic dermatitis trial measures the percentage change from baseline to Week 16 in the EASI score, which stands for Eczema Area and Severity Index, a tool used to assess the extent and severity of atopic dermatitis. The eosinophilic asthma trial measures the change from baseline to Week 12 in pre-bronchodilator FEV1, which is the amount of air a person can forcefully exhale in one second before taking a bronchodilator medication. The long-term asthma study measures the incidence of treatment-emergent adverse events and treatment-emergent serious adverse events from baseline through Week 52.
Who can take part in these trials?
The atopic dermatitis trial enrolls participants with moderate to severe atopic dermatitis and plans to include 200 participants. The eosinophilic asthma trial enrolls adult participants with uncontrolled moderate to severe eosinophilic asthma and plans to include 264 participants. The long-term asthma study enrolls participants with asthma who were previously enrolled in a KT-621 asthma study and plans to include 228 participants.
What side effects are known?
The provided sources do not report specific side effects of KT-621. The long-term asthma study is designed to evaluate the safety and tolerability of KT-621 by measuring treatment-emergent adverse events and serious adverse events over 52 weeks, but the registry records do not yet list any observed side effects.