Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis

NCT04753034 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TER101-AD-201
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 12

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percent Change in EASI From Baseline at Day 29

  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.

  29 days

Secondary Outcomes (4)

• Changes in EASI Over Time

  15 days

• Change in IGA From Baseline Over Time

  29 Days

• Changes in Itch Over Time

  29 days

• Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD

  29 days

Study Arms (2)

TER-101

EXPERIMENTAL

BID (twice daily) application

Drug: TER-101

Vehicle

PLACEBO COMPARATOR

Vehicle ointment, BID (twice daily) application

Drug: Vehicle

Interventions

TER-101 DRUG

Active Comparator

TER-101

Vehicle DRUG

Placebo Comparator

Vehicle

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Teres Bio, Inc.: lead

Study Sites (12)

Teres Bio site 05

Scottsdale, Arizona, 85255, United States

Location

Teres Bio Site 04

Encinitas, California, 92024, United States

Location

Teres Bio Site 12

North Miami Beach, Florida, 33162, United States

Location

Teres Bio Site 10

Tampa, Florida, 33613, United States

Location

Teres Bio Site 02

Clarksville, Indiana, 47129, United States

Location

Teres Bio Site 01

Louisville, Kentucky, 40241, United States

Location

Teres Bio site 09

Saint Joseph, Missouri, 64506, United States

Location

Teres Bio Site 08

High Point, North Carolina, 27262, United States

Location

Teres Bio Site 11

Wilmington, North Carolina, 28405, United States

Location

Teres Bio Site 03

College Station, Texas, 77845, United States

Location

Teres Bio Site 06

Pflugerville, Texas, 78660, United States

Location

Teres Bio Site 07

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: VP, Clinical Operations
• Organization: Aditum Bio

Chris.resburg@aditumbio.com

(510) 227-2102

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 12, 2021
• Study Start: January 18, 2021
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: July 26, 2022
• Results First Posted: July 19, 2022

Record last verified: 2021-02

Locations

US (12)