RecruitingPhase 1NCT06628206

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


Sponsor

LAPIX Therapeutics Inc.

Enrollment

48 participants

Start Date

Dec 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase safety study of a new investigational drug called LPX-TI641 in patients with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) — inflammatory joint diseases. The study focuses on understanding the drug's safety, tolerability, and how the body processes it. **You may be eligible if...** - You are 18 or older with a BMI between 18 and 35 - You have been diagnosed with rheumatoid arthritis (RA) meeting 2010 ACR/EULAR criteria for at least 3 months, with active disease (at least 6 tender and 6 swollen joints), OR you have psoriatic arthritis (PsA) with active skin and joint disease - Your disease remains active despite current treatment **You may NOT be eligible if...** - You have had a prior serious adverse reaction to a biologic therapy - You have significant infections, organ problems, or other conditions that could make the study unsafe - You do not meet the active disease criteria at both screening and enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLPX-TI641

Oral administration QD for 28 consecutive days

DRUGPlacebo

Drug is LPX-TI641. Placebo an identical formulation without the LPX-TI641.


Locations(1)

Triumpharma Clinical Research Unit at AlEssra Hospital

Amman, Jordan

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NCT06628206


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