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Atopic Dermatitis (AD)Phase 1NCT06982352

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

A Phase 1 study testing LPX-TI641 in people with Atopic Dermatitis (AD) and Psoriasis (PsO), run by LAPIX Therapeutics Inc. at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis (AD), Psoriasis (PsO)
What is being tested?
LPX-TI641
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
3 sitesin 2 countries
Study dates
15 Jun 2025to 15 Apr 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • For Atopic Dermatitis Cohort:
  • Diagnosis of AD at least 12 months prior to screening, as defined by the American Academy of Dermatology: Guidelines of care for the management of atopic dermatitis (Eichenfield 2014):
  • EASI score ≥ 16 at Screening and baseline (Day 0)
  • vIGA score of ≥3 at screening and baseline (Day 0)
  • ≥10% of body surface area (BSA) involvement at screening and baseline (Day 0)
  • Peak pruritis NRS≥4 (average score of daily scores 7 days before Day 0)
  • History, documented by a physician and/or investigator, of inadequate response to existing topical medications within 6 months preceding screening, or history of intolerance to topical therapy as defined by at least 1 of the following:
  • Inability to achieve good disease control defined as mild disease or better (e.g., IGA≤2) after use of at least a medium potency topical corticosteroid (TCS) for at least 4 weeks, or for the maximum duration recommended by the product prescribing information (e.g. 14 days for super potent TCS), whichever is shorter (Note: a TCS may be used with or without topical calcineurin inhibitors [TCNIs])
  • Documented history of clinically significant adverse reactions with the use of TCS, such as skin atrophy, allergic reactions, or systemic effects that, in the opinion of the investigator, outweigh the benefits of retreatment
  • Failed systemic therapies intended to treat AD within 6 months preceding screening (will be considered as having inadequate response to topical therapy)
  • Documented history of clinically significant adverse reactions with the use of TCS, such as skin atrophy, allergic reactions, or systemic effects that, in the opinion of the investigator, outweigh the benefits of retreatment
  • For Plaque Psoriasis Cohort:
  • Confirmed diagnosis of plaque psoriasis for at least 6 months prior to baseline (Day 0)
  • Plaque psoriasis involving ≥10% body surface area (BSA) in the affected skin other than the face and scalp at screening and baseline (Day 0)
  • Static Physician's Global Assessment (sPGA) score ≥3 at screening and baseline (Day 0)
  • PASI score of ≥12 at screening and baseline (Day 0)
  • Subject must be candidate for phototherapy or systemic therapy
  • Subject had no significant flare in psoriasis for at least 3 months before screening

Who cannot join

  • 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
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  • 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.
  • Laboratory values of the following at the Screening Visit:
  • Hemoglobin < 11 g/dL
  • WBC <3.5X109/L
  • Absolute neutrophil count (ANC) < 1500 cells/µL, (or < 1200 cells/µL for participants of African descent who are black)
  • Aspartate aminotransferase or alanine aminotransferase > 2.0 x the upper limit of normal (ULN) or bilirubin >= ULN;
  • Bilirubin > ULN
  • Platelets < 100,000 cells/[mm^3] (10^9/L)
  • Clinically significant abnormal screening laboratory results as evaluated by the Investigator
  • Acutely worsened renal function within past 3 months prior to screening or estimated GFR by CDK-EPI creatinine equation with adjustment for body surface area <60ml/min.
  • Subject has any clinically significant finding on 12-lead ECG at screening or admission. NOTE: QTc(F) interval of >450 msec in male participants or >470 msec in female participants will be the basis for exclusion from the study. ECG may be repeated once for confirmatory purposes if initial values obtained exceed the limits specified.
  • Subject with positive results for HBsAg (hepatitis B surface antigens) and/or HBcAb (Hepatitis B core antibodies) and/or HCV Ab (hepatitis C antibodies) confirmed by HCV RNA, and/or HIV Ab (human immunodeficiency virus antibodies).
  • Blood loss of >250 mL or donated blood within 56 days or donated plasma within 7 days of screening.
  • Recent vaccination with live attenuated vaccines such as influenza, MMR, Herpes zoster, varicella, yellow fever, Rotavirus vaccine, etc., or inactivated vaccines such as Hepatitis A, rabies vaccine, etc. 30 days prior to screening visit
  • Subject has known sensitivity to any of the components of the investigational product.
  • Subject is investigative site personnel, sponsor personnel, or a member of their immediate families (spouse, parent, child or sibling whether biological or legally adopted).

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Anas M Fathallah, PhD contact

6172035516

anas.fathallah@lapixtherapeutics.com

Nimita Dave, PhD contact

5139071470

nimita.dave@lapixtherapeutics.com

3 sites in 2 countries

United States2 sites, 2 recruiting

  • Clinical Investigations of Texas

    Dallas, Texas, 75075

    Sangram Raut, PhD, 9725991530, info@clinicalinvestigationsoftexas.com

    Recruiting

  • Red River Research Partners

    Fargo, North Dakota, 58103

    Recruiting

Other trials in United States

Jordan1 site, 1 recruiting

  • Triumpharma Clinical Research Unit at AlEssra Hospital

    Amman, Jordan, B204

    Recruiting

Other trials in Jordan

About this study

Official title: Phase 1b Randomized, Double Blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LPX-TI641 in Patients With Atopic Dermatitis and Psoriasis

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.

Read the detailed description

This is a Phase 1b, multi-center, randomized, double-blind, parallel-group, placebo-controlled multiple dose study in participants with atopic dermatitis or psoriasis.

There will be 2 cohorts, one for each indication. Each cohort will consist of ~ 16-24participants (Total ~up to 48 participants).

The Primary objective of the study is to evaluate the safety and tolerability after multiple oral doses of LPX-TI641 in participants with AD and PsO.

And the secondary objective of the study is to evaluate the plasma pharmacokinetics after multiple oral doses of LPX-TI641 in participants with AD and PsO.

Being tested
LPX-TI641, Placebo
Keywords
phase 1 study, safety, pharmacokinetics
Medical subject headings
Dermatitis, Atopic, Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LPX-TI641Drug

    Oral administration QD for 28 consecutive days

  • PlaceboDrug

    Placebo an identical oral formulation without the LPX-TI641.

Study groups in NCT06982352
Study groupRoleWhat they receive
PsoriasisExperimentalLPX-TI641 or Placebo
Receives: Drug: LPX-TI641; Drug: Placebo
Atopic dermatitisExperimentalLPX-TI641 or Placebo
Receives: Drug: LPX-TI641; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 84 days

Secondary outcomes (1)

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

    Measure Area Under the Concentration Time Curve after single dose and at Steady State

    Measured: 24 hours on Day 1 and 24 hours on Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2025
  2. Study start15 Jun 2025
  3. Primary completion15 Jan 2026 (estimated)
  4. Study completion15 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06982352
Sponsor's protocol ID
LPX641-103
Status last verified
Dec 2025
First submitted
13 May 2025
Last updated
19 Dec 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LPX-TI641 in people with Atopic Dermatitis (AD) and Psoriasis (PsO), run by LAPIX Therapeutics Inc. at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 43 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anas M Fathallah, PhD (6172035516, anas.fathallah@lapixtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability after multiple oral doses of LPX-TI641 in participants with PsO and AD. (time frame: 84 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06982352.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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