Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT06628206
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Sponsor:
LAPIX Therapeutics Inc.
Organization:
Study Overview
Official Title:
Phase 1b Randomized, Double Blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LPX-TI641 in Patients With Rheumatoid Arthritis and Psoriatic Arthritis
Status:
RECRUITING
Status Verified Date:
2025-04
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 clinical trial is to study the drug LPX-TI641 in patients with rheumatoid arthritis and psoriatic arthritis. We will compare the safety and tolerability of LPX-TI641 to placebo that contains no drug. We will also evaluate the plasma pharmacokinetics of LPX-TI641. LPX-TI641 (or placebo) will be administered orally for 28 days.
Detailed Description:
This is a Phase 1b, multi-center, randomized, double-blind, parallel-group, placebo-controlled multiple dose study in participants with rheumatological conditions (rheumatoid arthritis, psoriatic arthritis).
There will be 2 cohorts, one for each indication. Each cohort will consist of \~ 16-60 participants (Total \~up to 120 participants).
The Primary objective of the study is to evaluate the safety and tolerability after multiple oral doses of LPX-TI641 in participants with RA and PsA.
And the secondary objective of the study is to evaluate the plasma pharmacokinetics after multiple oral doses of LPX-TI641 in participants with RA and PsA.
There will be 2 cohorts, one for each indication. Each cohort will consist of \~ 16-60 participants (Total \~up to 120 participants).
The Primary objective of the study is to evaluate the safety and tolerability after multiple oral doses of LPX-TI641 in participants with RA and PsA.
And the secondary objective of the study is to evaluate the plasma pharmacokinetics after multiple oral doses of LPX-TI641 in participants with RA and PsA.
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?: