Phase 2
N=63
Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT04753034 ↗Enrolled (actual)
63
Serious AEs
1.6%
Results posted
Jul 2022
Primary outcome: Primary: Percent Change in EASI From Baseline at Day 29 — -47.37; -42.10 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TER-101 (Drug); Vehicle (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Teres Bio, Inc.
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in EASI From Baseline at Day 29 |
-47.37; -42.10 | — |
| SECONDARY Changes in EASI Over Time |
-35.96; -39.24 | — |
| SECONDARY Change in IGA From Baseline Over Time |
-0.7; -0.7 | — |
| SECONDARY Changes in Itch Over Time |
-2.0; -1.2 | — |
| SECONDARY Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD |
17; 15; 0; 2; 1; 2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04753034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.