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Clinical Trials/NCT04753034
NCT04753034CompletedPhase 2

A Multicenter, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of TER-101 Topical Ointment to Assess Efficacy and Safety in Subjects With Mild to Moderate Atopic

Teres Bio, Inc.12 sites in 1 country63 target enrollmentStarted: January 18, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
63
Locations
12
Primary Endpoint
Percent Change in EASI From Baseline at Day 29

Study Overview

Brief Summary

This Phase 2 study will assess efficacy, safety, and tolerability of TER-101 ointment and vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic dermatitis.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
12 Years to 65 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adolescent or adult subject aged 12 - 65 years.
  • Overall IGA score of 2 (mild) or 3 (moderate) at baseline on a 5-point IGA

Exclusion Criteria

  • AD with known hypersensitivity to excipients of TER-101 Ointment
  • Subjects who are immunocompromised

Arms & Interventions

TER-101

Experimental

BID (twice daily) application

Intervention: TER-101 (Drug)

Vehicle

Placebo Comparator

Vehicle ointment, BID (twice daily) application

Intervention: Vehicle (Drug)

Outcomes

Primary Outcomes

Percent Change in EASI From Baseline at Day 29

Time Frame: 29 days

EASI = Eczema Area and Severity Index, EASI combines the assessment of the severity of lesions and the the numerical area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for erythema, induration, lichenification, excoriation are multiplied with value of the area affected and with the percentage of the four body areas.

Secondary Outcomes

  • Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD(29 days)
  • Changes in EASI Over Time(15 days)
  • Change in IGA From Baseline Over Time(29 Days)
  • Changes in Itch Over Time(29 days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (12)

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