Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT07167758
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Evaluating TRIV-509 in Atopic Dermatitis
Sponsor:
Triveni Bio
Organization:
Study Overview
Official Title:
A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Multiple Subcutaneous Doses of TRIV-509 in Adults With Moderate to Severe Atopic Dermatitis
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this interventional study is to learn if TRIV-509 works to treat moderate to severe atopic dermatitis in adults. It will also evaluate the safety of TRIV-509.
Participants will receive 4 doses of the study intervention that they are randomized to (TRIV-509 or placebo), and at Week 16 will cross over and receive 4 doses of the other study intervention.
The study duration for individual participants is up to 57 weeks, including a Screening period of up to 30 days.
Participants will receive 4 doses of the study intervention that they are randomized to (TRIV-509 or placebo), and at Week 16 will cross over and receive 4 doses of the other study intervention.
The study duration for individual participants is up to 57 weeks, including a Screening period of up to 30 days.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: