A Study to Evaluate the Efficacy and Safety of Tanfanerce... | NCT06400589

Studies
A Study to Evaluate the Efficacy and Safety of Tanfanercept (HL036) in Dry Eye Disease

NCT06400589

Sponsor

HanAll BioPharma Co., Ltd.

Status

Suspended

Last Update Posted

May 31, 2024Actual

Enrollment

750Estimated

Phase

Phase 3

Conditions

Dry Eye

Interventions

tanfanercept
Vehicle

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

May 2024

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Logistical issue

Expanded Access Info

Start Date

May 1, 2024Actual

Primary Completion Date

Aug 2025Estimated

Completion Date

Aug 2025Estimated

First Submitted Date

Apr 29, 2024

First Submission Date that Met QC Criteria

May 2, 2024

First Posted Date

May 6, 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

May 29, 2024

Last Update Posted Date

May 31, 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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objectives of this study are to compare the efficacy and safety of tanfanercept ophthalmic solution 0.25% and 1.0% to vehicle for the treatment of DED.

Detailed Description

The purpose of this research study is to test the safety and effectiveness (how well the drug works) of Tanfanercept ophthalmic solution 0.25% and Tanfanercept ophthalmic solution 1% against vehicle (no active treatment). Effectiveness will be measured by the improvement in Schirmer Test results (a test to see how many tears you produce), reduction of dry eye symptoms, eye redness (conjunctival redness), and eye surface irritation (corneal staining, conjunctival staining). Eye safety assessments will also be performed.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

750Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.25% tanfanercept	Experimental	0.25% tanfanercept ou bid for 12 weeks	Drug: tanfanercept
1.0% tanfanercept	Experimental	1.0% tanfanercept ou bid for 12 weeks	Drug: tanfanercept
Vehicle	Placebo Comparator	Vehicle ou bid for 12 weeks	Drug: Vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tanfanercept	Drug	TNF inhibitor	0.25% tanfanercept 1.0% tanfanercept

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Schirmer Test	The proportion of participants with improvement from baseline in unanesthetized Schirmer	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Schirmer Test	Change from baseline in unanesthetized Schirmer test score	2 weeks, 4 weeks, 8 weeks, 12 weeks
Symptom Assessment in Dry Eye	Change from baseline in Symptom Assessment in Dry Eye

Other Outcomes

Measure	Description	Time Frame
Comfort Score (Exploratory)	Study product instillation score at each post-baseline visit	2 weeks, 4 weeks, 8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are at least 18 years of age
Provide written informed consent
Are willing to attend all study visits and able to comply with study procedures and assessments
Have a self-reported history of DED (OU) for at least 6 months prior to Visit 1

Exclusion Criteria:

Have an uncontrolled systemic disease
Have been exposed to an investigational drug or device within 30 days or 5 half-lives prior to Visit 1, whichever is longer

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HanAll Site #1		Delray Beach	Florida	33484	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided