๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-18

Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis (NCT06982352)

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: LAPIX Therapeutics Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (39 items) and avoid the listed exclusions (41 items).

Location: Red River Research Partners โ€” Fargo, North Dakota

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (3 Sites)

  • Red River Research Partners โ€” Fargo, North Dakota
  • Clinical Investigations of Texas โ€” Dallas, Texas
  • Triumpharma Clinical Research Unit at AlEssra Hospital โ€” Amman, Jordan

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—