Clinical Trials in the UK / NCT05120830
Active, not recruiting
Phase 1/2
NTLA-2002 in Adults With Hereditary Angioedema (HAE)
NCT05120830 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Hereditary Angioedema
Investigational drug(s) / intervention(s)
Biological NTLA-2002Normal Saline IV Administration
Biological NTLA-2002: CRISPR/Cas9 gene editing system delivered by LNP for IV administration
Normal Saline IV Administration: The administration of IV normal saline
Study summary
This study will be conducted to evaluate the safety, tolerability, activity, pharmacokinetics, and pharmacodynamics of NTLA-2002 in adults with Hereditary Angioedema (HAE).
Eligibility
Inclusion Criteria:
1. Age \>18 years
2. Diagnosis of HAE Types I or II
3. Ability to provide evidence of HAE attacks to meet the screening requirement
4. Subjects must have access to, and the ability to use, ≥ 1 acute medication(s) to treat angioedema attacks.
5. Adequate chemistry and hematology measures at screening
6. Subjects must agree not to participate in another interventional study for the duration of this trial.
7. Subjects must be capable of providing signed informed consent
Exclusion Criteria:
1. Concurrent diagnosis of any other type of recurrent angioedema
2. Subjects who have known negative reaction or hypersensitivity to any lipid nanoparticles (LNP) component.
3. Any condition that, in the Investigator's opinion, could adversely affect the safety of the subject.
4. Unwilling to comply with study procedures.
Primary outcome measure(s)
- Safety and tolerability of NTLA-2002 as determined by adverse events (AEs) and dose limiting toxicities (DLTs) — From NTLA-2002 infusion up to week 104 post-infusion
(Phase 1 only) - Number of HAE attacks per month (Weeks 1-16) — From study drug infusion up to week 16 post-infusion
(Phase 2 only)
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinical Trial Site | Campbelltown | Australia | |
| Clinical Trial Site | Grenoble | France | |
| Clinical Trial Site | Lille | France | |
| Clinical Trial Site | Paris | France | |
| Clinical Trial Site | Berlin | Germany | |
| Clinical Trial Site | Frankfurt | Germany | |
| Clinical Trial Site | Amsterdam | Netherlands | |
| Clinical Trial Site | Auckland | New Zealand | |
| Clinical Trial Site | Cambridge | United Kingdom |
More Intellia Therapeutics trials in the UK
Long-Term Follow-Up (LTFU) of Subjects Dosed With NTLA-2001
Enrolling by invitation
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
Active, not recruiting
Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002
Enrolling by invitation
Other trials for the same condition
STOP-HAE: A Phase 3 Study of ADX-324 in HAE
Recruiting
A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)
Active, not recruiting
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
Active, not recruiting
Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05120830 on ClinicalTrials.gov ↗ ← All trials in the UK