NCT06628206

Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: LAPIX Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis (RA)
• Psoriatic Arthritis (PsA)

Interventions

Type	Name	Description
DRUG	LPX-TI641	Oral administration QD for 28 consecutive days
DRUG	Placebo	Drug is LPX-TI641. Placebo an identical formulation without the LPX-TI641.

Timeline

• Start date: 2024-12-15
• Primary completion: 2025-12-15
• Completion: 2026-01-15
• First posted: 2024-10-04
• Last updated: 2025-11-20

Locations

1 site across 1 country: Jordan

Regulatory

• FDA-regulated drug study