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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Atopic Dermatitis (AD), Psoriasis (PsO)

In brief

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.

Key facts

Study ID

NCT06982352

Run by

LAPIX Therapeutics Inc.

People needed

48

Starts

2025-06-15

Expected to finish

2026-04-15

Last updated by the study team

2025-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Injectable
• Progestogen-only hormone contraception (oral or injectable) associated with inhibition of ovulation.
• Vasectomized partner
• Sexual abstinence -this is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated about the duration of the study and the preferred and usual lifestyle of the participant.
• A combination of male condoms with either cervical cap, diaphragm, or sponge with spermicide (double-barrier methods)
• The following applies to all male participants in the study:
• Sexual abstinence- this is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence must be evaluated for the study and the participant's preferred and usual lifestyle.
• A combination of male condoms with either cervical cap, diaphragm, or sponge with spermicide (double-barrier methods).
• Vasectomy
• Negative serum B-human chorionic gonadotropin test at screening (for all females) and negative urine pregnancy at randomization (Day 1) (females of childbearing potential) prior to administration of investigational product.

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
• Use of emollients.
• Receipt of any of the following excluded therapies as per below and throughout the study:
• Oral retinoids within 2 weeks of Day 0
• Systemic immunosuppressive/immunomodulating therapy (such as but not limited to systemic glucocorticoids, cyclosporine, mycophenolate mofetil, methotrexate, azathioprine, apremilast, or oral JAK inhibiting agents or phototherapy within 4 weeks before screening visit. Stable dose of max 1200ug inhaled budesonide (or equivalent) is allowed.
• Any cell depleting therapy, anti-CD4, anti-CD5, anti-CD3 other than anti-CD20 such as rituximab, ocrelizumab, and ofatumumab. Patients who have received rituximab or other selective B lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least 1 year prior to screening
• Biologics dugs including, but not limited to dupilumab, tralokinumab, ustekinumab, secukinumab, ixikizumab, anti-TNF inhibitors within 8 weeks or 5 drug elimination half-lives whichever is longer and throughout the study
• Failed biologics due to efficacy including, but not limited to dupilumab, tralokinumab, ustekinumab, secukinumab, ixikizumab, anti-TNF inhibitors
• PUVA or UVB phototherapy within 4 weeks prior to Day 0 and throughout the study.
• Subject has clinical or laboratory evidence of active or latent tuberculosis (TB) infection at screening as assessed by QuantiFERON-TB-Gold or a purified protein derivative skin test or equivalent (or both if required per local guidelines) and chest X-ray. Chest X-rays taken within 2 months prior to screening may be used instead of during screening if there is documentation showing no evidence of infection or malignancy as read by qualified physician.
• Any active or recurrent infection within 1) the past 8 weeks prior to screening requiring IV/hospitalization or 2) the past 2 weeks prior to screening requiring oral antibiotics.

Where it is running

• Red River Research Partners — Fargo, North Dakota, United States (enrolling)
• Clinical Investigations of Texas — Dallas, Texas, United States (enrolling)
• Triumpharma Clinical Research Unit at AlEssra Hospital — Amman, Jordan, Jordan (enrolling)

Full record on ClinicalTrials.gov

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