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

Teres Bio

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: TER-101; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT04753034

TER101-AD-201

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 2 patient groups, including a placebo group

TER-101

Experimental group

Description:

BID (twice daily) application

Treatment:

Drug: TER-101

Vehicle

Placebo Comparator group

Description:

Vehicle ointment, BID (twice daily) application

Treatment:

Drug: Vehicle