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Phase III Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study

Sponsor
LianBio LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05629390
Collaborator
(none)
162
Enrollment
2
Locations
2
Arms
15.3
Anticipated Duration (Months)
81
Patients Per Site
5.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Phase III main study is a randomized, controlled, multicenter, double-masked, parallel trial to evaluate the efficacy and safety of 0.25% TP-03, for the treatment of Demodex blepharitis in China. The PK sub-study is a single-arm, open-label trial to evaluate systemic Lotilaner PK of 0.25% TP-03 in whole blood following topical ocular administration

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The main study is designed to demonstrate the superiority of 0.25%TP-03 to vehicle for the treatment of Demodex blepharitis in China. The vehicle of TP-03 was selected as the control since there are no approved pharmaceutical treatments for Demodex blepharitis. The vehicle as the control will provide evidence that the active ingredient is responsible for the response, not the vehicle alone.

A pharmacokinetics (PK) sub-study is designed in this study to evaluate systemic PK parameters of 0.25% TP-03 in Chinese participants with Demodex blepharitis. The sites of PK sub-study are separate from those of the main study described as above.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled, Multicenter, Double-Masked, Parallel Phase III Trial to Evaluate the Efficacy and Safety of Lotilaner Ophthalmic Solution for the Treatment of Demodex Blepharitis in China With an Open-Label Pharmacokinetics Sub-Study
Actual Study Start Date :
Oct 23, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lotilaner Ophthalmic Solution (TP-03)

Lotilaner Ophthalmic Solution (TP-03)

Drug: Lotilaner
Lotilaner Ophthalmic Solution
Other Names:
  • TP-03
  • S-Misoxam

    		•
    Placebo Comparator: Vehicle Control

    Vehicle Control

    Drug: Vehicle Control
    Lotilaner Ophthalmic Solution during Phase III and PK study Vehicle Control during Phase III study

    Outcome Measures

    Primary Outcome Measures

    1. Collarette score of 0 for the upper eyelid of the analysis eye at Day 43 Demodex eradication based on the mite density of 0 mites/lash for the analysis eye at Day 43 [43 days]

      To demonstrate the efficacy of 0.25% TP-03 to eliminate collarettes and eradicate mite in Demodex blepharitis

    2. The assessment of treatment-related adverse effects [43 days]

      To demonstrate the safety of 0.25% TP-03 in Demodex blepharitis

    Secondary Outcome Measures

    1. Composite of collarette score of 0 and erythema score of 0 for the upper eyelid of the analysis eye at Day 43 [43 days]

      To demonstrate the efficacy of 0.25% TP-03 to eliminate collarettes and erythema from the eyelid margin

    2. Blood drug concentration of Lotilaner at Day 1 and Day 43 [43 days]

      To evaluate the blood drug concentration of Lotilaner following topical ocular administration of 0.25% TP-03

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female, aged ≥ 18 years of age.

    2. Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol.

    3. Has blepharitis

    4. Stated willingness to comply with all study procedures and availability for the duration of the study.

    Exclusion Criteria:

    1. Have used lid hygiene products (e.g., lid scrubs) within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study.

    2. Have initiated treatment with an ocular topical prostaglandin analogue within 30 days of Screening or have any plans to change or discontinue treatment during the study

    3. Pregnancy or lactation.

    4. Any intraocular surgery (including ocular surface surgery, cataract surgery and intravitreal injection) or periocular surgery within 60 days prior to randomization, or any planned ocular surgical procedure during the study period

    5. Have any unstable or uncontrolled, cardiac, pulmonary, renal, oncological, neurological, metabolic or other systemic condition that, in the opinion of the investigator, would possibly require the participant to seek emergent medical treatment during the course of this study. This includes, but is not limited to, unstable or uncontrolled cardiac arrhythmias, hypertension, coagulopathies, renal failure or advanced diabetes mellitus.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xiamen Eye Center of Xiamen University Xiamen Fujian China 361000
    2 Renmin Hospital of Wuhan University Wuhan Hubei China 430060

    Sponsors and Collaborators

    • LianBio LLC

    Investigators

    • Principal Investigator: Zuguo Liu, Doctor, Xiamen Eye Center of Xiamen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LianBio LLC
    ClinicalTrials.gov Identifier:
    NCT05629390
    Other Study ID Numbers:
    • LB4001-301
    First Posted:
    Nov 29, 2022
    Last Update Posted:
    Nov 29, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by LianBio LLC
    Blepharitis
    Additional relevant MeSH terms:
    Parasitic Diseases
    Blepharitis

    Study Results

    No Results Posted as of Nov 29, 2022