Evaluation of TL-925 for the Treatment of Allergic Conjun... | NCT06686472

Studies
Evaluation of TL-925 for the Treatment of Allergic Conjunctivitis

NCT06686472

Sponsor

Telios Pharma, Inc.

Status

Recruiting

Last Update Posted

Nov 13, 2024Actual

Enrollment

66Estimated

Phase

Phase 2

Conditions

Allergic Conjunctivitis

Interventions

TL-925
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 3, 2024Actual

Primary Completion Date

Dec 10, 2024Estimated

Completion Date

Dec 10, 2024Estimated

First Submitted Date

Nov 11, 2024

First Submission Date that Met QC Criteria

Nov 11, 2024

First Posted Date

Nov 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2024

Last Update Posted Date

Nov 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 66 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.

The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TL-925 Arm	Active Comparator	Subjects will be dosed in clinic.	Drug: TL-925
Placebo Arm	Placebo Comparator	Subjects will be dosed in clinic.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TL-925	Drug	TL-925 is an eye drop.	TL-925 Arm
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular Itching	Ocular itching score will be reported by the subject at 3 timepoints after CAC at Visits 4b , 5, and 6b. Assessments are reported using a 0-4 numerical scale (0 = none and 4 = incapacitating itch with an irresistible urge to rub).	3, 5 and 7 minutes after CAC
Conjunctival Redness	Conjunctival redness score will be evaluated by the investigator at 3 timepoints after CAC at Visits 4b, 5, and 6b. Assessments are completed using a 0-4 numerical scale (0 = none and 4 = extremely severe).	7, 15 and 20 minutes after CAC

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals aged 18 years or older
Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.
Documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 60 months.
Calculated best-corrected visual activity of 0.7 LogMAR or better
Positive bilateral CAC reaction

Exclusion Criteria:

Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study.
Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months
Any ongoing ocular infection (bacterial, viral or fungal)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
John Mei	Contact	(650) 542-0136		jmei@teliospharma.com
Yulia Khalina	Contact			ykhalina@teliospharma.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Telios Investigative Site	Recruiting	Memphis	Tennessee	38119	United States

Condition Browse Module

MeSH Terms

ID	Term
D003233	Conjunctivitis, Allergic

Ancestor Terms

ID	Term
D003231	Conjunctivitis
D003229	Conjunctival Diseases
D005128	Eye Diseases
D006969	Hypersensitivity, Immediate

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Quadruple

Masking Description

The sponsor, investigators, and study staff will be masked throughout the study. The study site will have the capacity to unmask in case of emergency. Following completion of the study, the randomization code will be unmasked once all data has been entered into the study database for every subject, and the database has been locked.

Who Masked

ParticipantCare ProviderInvestigatorOutcomes Assessor