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

NCT06628206 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: LPX641-102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis (RA); Psoriatic Arthritis (PsA)

Keywords

Phase 1 study; pharmacokinetics; safety

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability after multiple oral doses of LPX-TI641 in participants with RA and PsA.

  Rate and severity of treatment-emergent adverse events, including serious adverse events.

  56 days

Secondary Outcomes (2)

• To evaluate the plasma pharmacokinetics after multiple oral doses of LPX TI641 in participants with RA and PsA.

  24 hours on Day 1 and 24 hours on Day 28

• To evaluate the plasma pharmacokinetics after multiple oral doses of LPX TI641 in participants with RA and PsA

  24 hours on Day 1 and 24 hours on Day 28

Study Arms (2)

Rheumatoid arthritis

EXPERIMENTAL

LPX-TI641 or Placebo

Drug: LPX-TI641; Drug: Placebo

Psoriatic Arthritis

EXPERIMENTAL

LPX-TI641 or Placebo

Drug: LPX-TI641; Drug: Placebo

Interventions

LPX-TI641 DRUG

Oral administration QD for 28 consecutive days

Psoriatic Arthritis; Rheumatoid arthritis

Placebo DRUG

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

Psoriatic Arthritis; Rheumatoid arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed an Informed Consent Form (ICF) prior to any study-specific procedures being performed
• ≥ 18 years old, irrespective of their race and ethnicity.
• Body Mass Index (BMI) 18.0-35.0 kg/m2, inclusive, at screening.
• 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.
• 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 \>= 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.
• 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.
• 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.
• a. The following applies to all female participants with childbearing potential and female partners of male volunteers enrolled in the study.
• i. Implantable progestogen-only hormone contraception associated with inhibition of ovulation.
• ii. Intrauterine device. iii. Intrauterine hormone-releasing system. iv. Bilateral tubal occlusion. v. Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation:
• Oral
• Intravaginal

You may not qualify if:

• Any subject who meets any of the following criteria will not qualify for entry into the study:
• 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
• History of clinically significant per the PI's opinion drug or alcohol abuse within the last 6 months
• Pregnant or lactating women or women currently undergoing infertility treatments or women who intend to become pregnant during the time of study enrollment.
• 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.
• Any known history of a rheumatologic, autoimmune or cutaneous disease other than RA (except secondary Sjögren\'s syndrome), or PSA.
• Significant systemic involvement secondary to RA/PsA (active vasculitis, pulmonary fibrosis, or Felty\'s syndrome).
• Currently have non-plaque forms of psoriasis e.g. erythrodermic, guttate or pustular with the exception of nail psoriasis which is allowed.
• 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
• Receipt of any of the following excluded therapies:
• Any cell depleting therapy including but limited to anti-CD4, anti-CD5, anti-CD3, rituximab, ocrelizumab, or ofatumumab.
• Have received prior tsDMARDs including but not limited to inhibitors of Janus kinase (JAK), Bruton tyrosine kinase, or tyrosine kinase 2, including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib.
• Lack of response to \> 1 therapeutic agent targeting tumor necrosis factor.
• If on prednisone, subject must be on stable dose, not to exceed equivalent of 10mg of prednisone per day (RA and PsA), and dose must be stable for ≥ 4 weeks prior to Day 1. No injected corticosteroids 8 weeks prior to first dose of study drug (e.g intraarticular, intramuscular, or intravenous)
• Use of psoriasis treatments:

Sponsors & Collaborators

• LAPIX Therapeutics Inc.: lead

Study Sites (1)

Triumpharma Clinical Research Unit at AlEssra Hospital

Amman, ST B204, Jordan

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Central Study Contacts

Anas M Fathallah, PhD

CONTACT

6172035516; anas.fathallah@lapixtherapeutics.com

Nimita Dave, PhD

CONTACT

5139071470; nimita.dave@lapixtherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There will be 2 cohorts, one for each indication. Each cohort will consist of \~ 16-to-60 participants (Total \~up to 120 participants in the study). The first cohort is for RA and in this cohort the first 5 participants will receive LPX-TI641 at 60 mg QD (4 mg/mL formulation) or placebo for 28 days (randomized in 3:2 treatment:placebo). Subsequently, 3 RA participants will receive LPX-TI641 at 60 mg QD (16 mg/mL formulation, (non-randomized). The next 8 RA participants (randomized in 3:1 treatment:placebo) will receive LPX-TI641 at 120 mg QD (4 participants 4 mg/ml formulation and 4 participants 16 mg/ml formulation). The remaining participants in the RA cohort (up to 44 participants) will receive the compounded capsule formulation with 150 mg LPX-TI641 or placebo (3:1 treatment:placebo). The psoriatic arthritis cohort will receive the compounded capsule formulation with 150 mg LPX-TI641 or placebo. Overall, participants in both cohorts will be randomized in a 3:1 ratio.

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 4, 2024
• Study Start: December 15, 2024
• Primary Completion: December 15, 2025
• Study Completion: January 15, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)