LPX-TI641 for Atopic Dermatitis and Psoriasis

ND
AM
Overseen ByAnas M Fathallah, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LPX-TI641, for individuals with atopic dermatitis and psoriasis. The main goal is to assess the safety and tolerability of LPX-TI641 compared to a placebo (a look-alike solution with no active medication). Participants will take the drug or placebo orally for 28 days. This trial suits individuals with atopic dermatitis who have struggled with topical treatments or those with plaque psoriasis covering at least 10% of their body. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications. The trial excludes participants using specific topical and systemic treatments, such as corticosteroids, immunosuppressive therapies, and biologics, for a period before and during the study. Please consult with the trial team for guidance on your specific medications.

Is there any evidence suggesting that LPX-TI641 is likely to be safe for humans?

Research has shown that LPX-TI641 has undergone safety testing in earlier studies. These studies found LPX-TI641 to be safe and well-tolerated at doses ranging from 10 mg to 150 mg. No major safety concerns were reported, indicating that participants generally handled the treatment well with few unwanted side effects. As this trial is in its early stages, more information will be collected to confirm these findings, but the initial results are promising for safety.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about LPX-TI641 for treating atopic dermatitis and psoriasis because it offers a new approach compared to standard treatments like topical corticosteroids and biologics. Unlike these conventional options, LPX-TI641 targets specific pathways involved in the inflammation process with a novel mechanism of action, potentially reducing side effects and improving efficacy. This targeted approach could provide faster relief and longer-lasting results for patients, making it a promising alternative to current therapies.

What evidence suggests that LPX-TI641 might be an effective treatment for atopic dermatitis and psoriasis?

Research has shown that LPX-TI641 may help treat atopic dermatitis and psoriasis. In this trial, participants will receive either LPX-TI641 or a placebo for their respective condition. Early studies suggest the drug is safe and well-tolerated in doses from 10 mg to 150 mg, without causing serious side effects. LPX-TI641 likely works by increasing certain immune cells that help control inflammation, potentially reducing symptoms of these skin conditions. Although these findings are preliminary, they offer hope for people with these chronic skin issues.12346

Are You a Good Fit for This Trial?

This trial is for adults with atopic dermatitis or psoriasis who are in good health as determined by medical history, physical exams, and lab tests. They must have a BMI between 18-40 kg/m2 and agree to follow the study's protocol. Women of childbearing potential and men with partners must use two effective contraception methods.

Inclusion Criteria

1. Subject has signed an Informed Consent Form (ICF) prior to any study-specific procedures being performed
3. Body Mass Index (BMI) 18.0-40.0 kg/m2, inclusive, at screening.
5. 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.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LPX-TI641 or placebo as an oral solution for 28 days

4 weeks
Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LPX-TI641
Trial Overview The trial studies LPX-TI641 compared to a placebo in treating atopic dermatitis and psoriasis. Participants will take an oral solution of either LPX-TI641 or placebo for 28 days while researchers monitor safety, tolerability, and how the drug behaves in the bloodstream.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: PsoriasisExperimental Treatment2 Interventions
Group II: Atopic dermatitisExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

LAPIX Therapeutics Inc.

Lead Sponsor

Trials
3
Recruited
260+

Citations

Safety and Pharmacokinetics of LPX-TI641 in Atopic ...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 ...
LPX-TI641 for Atopic Dermatitis and PsoriasisThe 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 ...
LPX-TI641 - Drug Targets, Indications, PatentsThe Phase 1 clinical trial results showed LPX-TI641 to be safe and well tolerated over the course of the tested oral doses from 10 mg to 150 mg in the SAD, and ...
LAPIX Therapeutics Announces Positive Topline Phase 1 ...The Phase 1 clinical trial results showed LPX-TI641 to be safe and well tolerated over the course of the tested oral doses from 10 mg to 150 mg ...
LPX-TI641 / LAPIX TherapLAPIX Therapeutics Doses First Patient-In Phase 1b Clinical Trial of LPX-TI641 for Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA) (GlobeNewswire) ...
Safety and Pharmacokinetics of LPX-TI641 in Atopic ...Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis. PHASE1 Active, not recruitingINTERVENTIONAL. Enrollment. 48. Participants. Timeline.
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