Actively Recruiting
Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis
Led by LAPIX Therapeutics Inc. · Updated on 2025-12-19
48
Participants Needed
3
Research Sites
43 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 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
Official Title
Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis
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 40.0 kg/m2 at screening
- Willing and able to follow study requirements including visits, inpatient stay, lab tests, and ECGs
- Judged to be in good health based on clinical evaluations and screening tests
- Females must be postmenopausal, permanently sterilized, or use two highly effective contraception methods if capable of pregnancy; males with partners of childbearing potential must also use two highly effective contraception methods
- Negative pregnancy tests for females of childbearing potential at screening and randomization
- For atopic dermatitis cohort: diagnosis for at least 12 months with EASI score ≥16, vIGA score ≥3, ≥10% body surface area involvement, and peak pruritis NRS ≥4; history of inadequate response or intolerance to topical medications
- For plaque psoriasis cohort: diagnosis for at least 6 months with ≥10% body surface area affected (excluding face and scalp), sPGA score ≥3, PASI score ≥12; candidate for phototherapy or systemic therapy; no significant flare in past 3 months
You will not qualify if you...
- Clinically significant medical conditions or other reasons interfering with participation
- Drug or alcohol abuse within last 6 months
- Pregnant or lactating women, or women undergoing infertility treatments or planning pregnancy during study or 6 weeks after last dose
- Skin conditions that interfere with study assessment or treatment response
- History of malignancy within 5 years except certain treated skin cancers or carcinoma in situ
- Current or recent skin infections requiring treatment
- Symptomatic herpes zoster within 3 months
- For psoriasis cohort: unstable or drug-induced psoriasis, recent oral/parenteral corticosteroid use
- Recent investigational therapy use
- Use of topical corticosteroids, immune modulators, PDE4 or JAK inhibitors, antihistamines, or emollients before and during study
- Use of oral retinoids, systemic immunosuppressive/immunomodulating therapies, certain biologics, or phototherapy before and during study
- Active or latent tuberculosis
- Recent serious infections requiring hospitalization or antibiotics
- Abnormal lab values including low hemoglobin, white blood cells, platelets, or elevated liver enzymes
- Worsened renal function recently or low estimated GFR
- Abnormal ECG findings
- Positive hepatitis B, hepatitis C, or HIV tests
- Recent blood donation or vaccination with live or certain inactivated vaccines
- Known sensitivity to study drug components
- Study site or sponsor personnel or their immediate family members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Red River Research Partners
Fargo, North Dakota, United States, 58103
Actively Recruiting
2
Clinical Investigations of Texas
Dallas, Texas, United States, 75075
Actively Recruiting
3
Triumpharma Clinical Research Unit at AlEssra Hospital
Amman, Jordan, Jordan, 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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