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Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06628206•LAPIX Therapeutics Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject has signed an Informed Consent Form (ICF) prior to any study-specific procedures being performed
•2. ≥ 18 years old, irrespective of their race and ethnicity.
•3. Body Mass Index (BMI) 18.0-35.0 kg/m2, inclusive, at screening.
•4. Participants are willing and able to adhere to study protocol requirements including but not limited to scheduled outpatient visits, inpatient hospital stay, laboratory tests, and 12-lead ECGs.
•5. A. Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA at least 3 months prior to screening AND Active disease defined by ≥ 6 tender out of 68 joints and ≥ 6 swollen out of 66 swollen joint count at both screening and Day 1.
•AND Participants received conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy for ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The csDMARD allowed include methotrexate (MTX) (≤ 25mg/week), sulfasalazine (3 grams a day), hydroxychloroquine (≤400mg/day), chloroquine (≤250mg/day), and leflunomide (≤ 20mg/day) or intolerance to csDMARD as assessed by the investigator OR B. PsA diagnosis of at least 3 months duration prior to the date of first screening with Classification of Psoriatic Arthritis (CASPAR) confirmed diagnosis at Screening. Have active psoriasis defined by at least 1 psoriasis lesion \&amp;gt;= 2 cm diameter in areas other than the axilla or groin.
•AND Active disease defined by ≥ 3 tender out of 68 joints and ≥ 3 swollen out of 66 swollen joint count at both screening and Day 1.
•AND Participants received standard doses of NSAIDS for ≥4 weeks or csDMARDS (MTX ≤ 25mg/week), sulfasalazine (3 grams a day), and leflunomide (≤ 20mg/day), administered for ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug or intolerance to NSAIDS or DMARDs as assessed by the investigator. Other traditional DMARDS not listed as a prohibited concomitant medication may be considered after discussion with the Study physician.
•6. The subject must be judged to be in good health by the investigator to participate in the study, based on clinical evaluations, including laboratory safety tests, medical history, physical examination, vital signs and 12-lead ECG competed at the screening visit and prior to the first dose of study drug.
•7. Female subject is postmenopausal (at least 1 year; to be confirmed by follicle stimulating hormone (FSH) if less than 2 years since last menstrual period), permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy or if of childbearing potential and engaged in sexual activity that can result in pregnancy must agree to use any two of the highly effective contraception methods listed below. Male participants with a partner of childbearing potential must also agree to use any two of the highly effective contraception methods listed below between the both of them. This criterion must be followed from screening visit to 6 weeks after the last dose in females and for 90 days after the last dose for males.
+34 more criteria

Exclusion Criteria

•Any subject who meets any of the following criteria will not qualify for entry into the study:
•1. History of clinically significant medical conditions or any other reason that in the opinion of the PI would interfere with subject's participation in this study
•2. History of clinically significant per the PI's opinion drug or alcohol abuse within the last 6 months
•3. Pregnant or lactating women or women currently undergoing infertility treatments or women who intend to become pregnant during the time of study enrollment.
•4. Any known history of malignancy within 5 years other than other than completely treated non-metastatic basal cell carcinomas or squamous cell carcinomas of the skin or localized carcinoma in situ of the cervix.
•5. Any known history of a rheumatologic, autoimmune or cutaneous disease other than RA (except secondary Sjögren\&amp;#39;s syndrome), or PSA.
•6. Significant systemic involvement secondary to RA/PsA (active vasculitis, pulmonary fibrosis, or Felty\&amp;#39;s syndrome).
•7. Currently have non-plaque forms of psoriasis e.g. erythrodermic, guttate or pustular with the exception of nail psoriasis which is allowed.
•8. Receipt of an investigational therapy less than 3 months or 5 drug-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study
•9. Receipt of any of the following excluded therapies:
+2 more criteria

Locations (1)

Triumpharma Clinical Research Unit at AlEssra Hospital

Amman, Jordan

Key Dates

Start Date

December 15, 2024

Primary Completion Date

December 15, 2025

Completion Date

January 15, 2026

Last Updated

November 20, 2025

Enrollment

ESTIMATED participants

Conditions

Rheumatoid Arthritis (RA)Psoriatic Arthritis (PsA)

Interventions

LPX-TI641

DRUG

Placebo

DRUG

Contacts

Anas M Fathallah, PhD

CONTACT

6172035516 anas.fathallah@lapixtherapeutics.com

Nimita Dave, PhD

CONTACT

5139071470 nimita.dave@lapixtherapeutics.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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