Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis

NCT06982352 | Recruiting Phase 1 FDA Drug

• 1 other identifier: LPX641-103
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 3

Brief Summary

The goal of this clinical trial is to study the drug LPX-TI641 in patients with atopic dermatitis and psoriasis. We will compare the safety and tolerability of LPX-TI641 to placebo ( a look-alike solution) 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

Atopic Dermatitis (AD); Psoriasis (PsO)

Keywords

phase 1 study; safety; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

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

  84 days

Secondary Outcomes (1)

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

  24 hours on Day 1 and 24 hours on Day 28

Study Arms (2)

Psoriasis

EXPERIMENTAL

LPX-TI641 or Placebo

Drug: LPX-TI641; Drug: Placebo

Atopic dermatitis

EXPERIMENTAL

LPX-TI641 or Placebo

Drug: LPX-TI641; Drug: Placebo

Interventions

LPX-TI641 DRUG

Oral administration QD for 28 consecutive days

Atopic dermatitis; Psoriasis

Placebo DRUG

Placebo an identical oral formulation without the LPX-TI641.

Atopic dermatitis; Psoriasis

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) 18.0-40.0 kg/m2, inclusive, at screening.
• Participants are willing and able to adhere to study protocol requirements and restrictions including but not limited to scheduled outpatient visits, inpatient stay, laboratory tests, and 12-lead ECGs.
• 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 completed 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 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 them and their partner. 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.
• The following applies to all female participants with childbearing potential and female partners of male participants enrolled in the study.
• Implantable progestogen-only hormone contraception associated with inhibition of ovulation.
• Intrauterine device.
• Intrauterine hormone-releasing system.
• Bilateral tubal occlusion.
• Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation:
• Oral
• Intravaginal
• Transdermal

You may not qualify if:

• 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 drug or alcohol abuse per the PI's opinion 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 or for 6 weeks after last dose.
• Presence of skin comorbidities that would interfere with study assessment or response to treatment
• Any known history of malignancy within 5 years other than completely treated non-metastatic basal cell carcinomas or squamous cell carcinomas of the skin or localized carcinoma in situ of the cervix.
• Patients who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics
• Symptomatic herpes zoster within 3 months of screening
• For the plaque psoriasis cohort,
• Unstable forms of PsO (acute guttate PsO, psoriatic erythroderma, generalized pustular PsO, or other unstable form as judged by the investigator), or drug-induced psoriasis.
• History of any non-PsO disease that required treatment with oral or parenteral corticosteroids for more than 2 weeks within the past 24 weeks prior to signing the informed consent form (ICF)
• 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
• Use of the following topical medications/emollients which could affect assessment of disease activity for at least 2 weeks prior to baseline (Day 0) and throughout the study:
• Topical corticosteroids or topical immune modulators (e.g. tacrolimus or pimecrolimus)
• Topical phosphodiesterase type 4 (PDE 4) inhibitor or JAK inhibitors or aryl hydrocarbon receptor agonists
• Topical or systemic antihistamines

Sponsors & Collaborators

• LAPIX Therapeutics Inc.: lead

Study Sites (3)

Red River Research Partners

Fargo, North Dakota, 58103, United States

RECRUITING

Clinical Investigations of Texas

Dallas, Texas, 75075, United States

RECRUITING

Triumpharma Clinical Research Unit at AlEssra Hospital

Amman, Jordan, B204, Jordan

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 1b, multi-center, randomized, double-blind, parallel-group, placebo-controlled multiple ascending doses (MAD) study in participants with atopic dermatitis, or psoriasis. There will be 2 cohorts, one for each indication. Each cohort will consist of \~12-24 participants (Total \~up to 48 participants). . Each cohort will consist of \~20-to-24 participants (Total \~up to 48 participants in the trial) treated QD for 28 days. The first cohort is for Atopic Dermatitis (AD), where the participants will receive 150 mg LPX-TI641 QD or placebo for 28 days (3:1, treatment: placebo randomization). The Plaque psoriasis (PsO) cohort may be treated concurrently or sequentially with the Atopic Dermatitis (AD) cohort. Participants in the PsO cohort will be randomized in a 3:1 ratio for LPX-TI641 150 mg QD: placebo QD treatment for 28 days.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: June 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: April 15, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

JO (1); US (2)