Actively Recruiting
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Led by LAPIX Therapeutics Inc. · Updated on 2025-11-20
48
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Age 18 years or older
- Body Mass Index between 18.0 and 35.0 kg/m2 at screening
- Willing and able to follow study visits, hospital stay, labs, and ECGs
- Diagnosis of rheumatoid arthritis meeting 2010 ACR/EULAR criteria for at least 3 months with active disease defined by at least 6 tender and 6 swollen joints at screening and Day 1, and on stable csDMARD therapy for at least 4 weeks prior to first dose; OR diagnosis of psoriatic arthritis for at least 3 months confirmed by CASPAR criteria with active psoriasis lesion larger than 2 cm (not in axilla or groin) and active disease defined by at least 3 tender and 3 swollen joints at screening and Day 1, and on stable NSAIDs or csDMARDs for at least 4 weeks prior to first dose
- Judged to be in good health by investigator based on clinical evaluations, labs, medical history, physical exam, vital signs, and ECG at screening and before first dose
- Female participants must be postmenopausal, permanently sterilized, or if of childbearing potential, agree to use two highly effective contraception methods from screening to 6 weeks after last dose; male participants with partners of childbearing potential must also agree to use two highly effective contraception methods from screening to 90 days after last dose
- Negative pregnancy tests for females of childbearing potential at screening and randomization
You will not qualify if you...
- History of significant medical conditions or other reasons interfering with study participation per investigator
- History of significant drug or alcohol abuse within last 6 months
- Pregnant, lactating, undergoing infertility treatments, or planning pregnancy during study
- Malignancy within 5 years except treated non-metastatic basal or squamous cell skin carcinoma or localized cervical carcinoma in situ
- Known rheumatologic, autoimmune, or skin diseases other than RA (except secondary Sj�f6gren's syndrome) or PsA
- Significant systemic involvement from RA/PsA such as active vasculitis, pulmonary fibrosis, or Felty's syndrome
- Non-plaque forms of psoriasis except nail psoriasis
- Receipt of investigational therapy within 3 months or 5 drug half-lives before first dose
- Prior cell depleting therapy, certain tsDMARDs, or immunomodulatory bDMARDs
- Lack of response to more than 1 TNF-targeting therapy
- Use of prednisone over 10 mg/day or unstable dose; no corticosteroid injections within 8 weeks prior to first dose
- Recent or ongoing use of certain psoriasis treatments and phototherapies
- Use of high potency opioid analgesics within 2 weeks prior to baseline
- COVID-19 infection during screening or recent vaccination or antiviral therapy within 30 days prior to screening
- Active or latent tuberculosis, recent infections requiring antibiotics
- Abnormal lab values at screening including low hemoglobin, low white blood cells, abnormal liver enzymes, abnormal kidney function, low platelets
- Acutely worsened renal function within 3 months or creatinine clearance under 60 ml/min
- Positive for hepatitis B, C, or HIV antibodies
- Recent blood or plasma donation
- Recent vaccination with live or inactivated vaccines within 30 days
- Recent serious infections needing hospitalization or antimicrobial therapy
- Study site personnel or immediate family members involved in the trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Triumpharma Clinical Research Unit at AlEssra Hospital
Amman, Jordan, ST B204
Actively Recruiting
Research Team
A
Anas M Fathallah, PhD
CONTACT
N
Nimita Dave, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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