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Gene Editing Therapy

NTLA-2002 for Hereditary Angioedema (HAELO Trial)

Phase 3
Recruiting
Research Sponsored by Intellia Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

"This trial will test if NTLA-2002 is effective and safe for treating adults with HAE compared to a placebo."

Who is the study for?
This trial is for adults with Hereditary Angioedema (HAE), a condition causing repeated swelling episodes. Participants must meet certain health criteria, but specific inclusion and exclusion details are not provided.
What is being tested?
The study tests NTLA-2002's effectiveness and safety against a placebo in managing HAE symptoms. A placebo group receives normal saline IV, which has no therapeutic effect, to compare results.
What are the potential side effects?
While the side effects of NTLA-2002 are not listed here, common side effects for new treatments may include reactions at the injection site, headaches, nausea, or fatigue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Arm A: NTLA-2002Active Control1 Intervention
Arm A: NTLA-2002 (50 mg; single IV infusion)
Group II: Arm B: PlaceboPlacebo Group1 Intervention
Arm B: Placebo (saline; single IV infusion)

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Who is running the clinical trial?

Intellia TherapeuticsLead Sponsor
9 Previous Clinical Trials
1,262 Total Patients Enrolled
~40 spots leftby Apr 2026
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