Phase 2
Completed N=23
Safety, Tolerability, and PK of AN2728 in Adolescents With Atopic Dermatitis
Dermatitis, Atopic
Source: ClinicalTrials.gov NCT01652885 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Number of Participants With Local Tolerability Symptoms According to Severity on Baseline — 10; 7; 6; 0 participants
Summary
The purpose of this study is to investigate the safety, tolerability, and systemic exposure of AN2728 Topical Ointment, 2%, in subjects with atopic dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Local Tolerability Symptoms According to Severity on Baseline |
10; 7; 6; 0 | — |
| PRIMARY Number of Participants With Local Tolerability Symptoms According to Severity on Day 2 |
17; 5; 1; 0 | — |
| PRIMARY Number of Participants With Local Tolerability Symptoms According to Severity on Day 4 |
18; 3; 2; 0 | — |
| PRIMARY Number of Participants With Local Tolerability Symptoms According to Severity on Day 6 |
18; 4; 1; 0 | — |
| PRIMARY Number of Participants With Local Tolerability Symptoms According to Severity on Day 8 |
20; 3; 0; 0 | — |
| PRIMARY Number of Participants With Local Tolerability Symptoms According to Severity on Day 9 |
18; 4; 1; 0 | — |
| PRIMARY Number of Participants With Local Tolerability Symptoms According to Severity on Day 15 |
19; 4; 0; 0 | — |
| PRIMARY Number of Participants With Local Tolerability Symptoms According to Severity on Day 22 |
21; 2; 0; 0 | — |
| PRIMARY Number of Participants With Local Tolerability Symptoms According to Severity on Day 29 |
20; 2; 0; 1 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
10; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Vital Signs Abnormalities |
— | — |
| PRIMARY Number of Participants With Clinically Significant Laboratory Test Abnormalities |
— | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 |
105; 28.2; 998 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 |
2.37; 2.08; 6.25 | — |
| PRIMARY Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 |
448; 142; 8900 | — |
| PRIMARY Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 1 |
7.17; 8.19; 17.7 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 |
94.6; 26.3; 1850 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 |
2.17; 3.94; 6.00 | — |
| PRIMARY Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 |
462; 142; 18200 | — |
| PRIMARY Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 8 |
11.9; 10.5; 33.5 | — |
| SECONDARY Number of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) |
9 | — |
| SECONDARY Change From Baseline in Signs and Symptoms of Atopic Dermatitis at Day 8, 15, 22 and 29 |
1.63; -0.63; -0.70; -0.87; -0.89; 1.87 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female 12 to 17 years of age, inclusive
- Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka)
- AD in treatable areas (excludes the scalp and venous access areas) involving
≥10% and ≤35% of the total body surface area(BSA)
- Investigator's Static Global Assessment (ISGA) score of 2 or 3
- Normal or not clinically significant screening laboratory results
- Have adequate venous access to permit repeated PK sampling on Days 1 - 9 through uninfected skin that has not been treated with study drug; each untreated venous access area should provide a margin of at least 5 cm radius around the venipuncture site
- Willing and able to comply with study instructions and commit to attending all visits
- Females must use a highly effective method of birth control.
- Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has the ability to give assent
Exclusion Criteria
- Significant confounding conditions as assessed by study doctor
- Unstable or actively infected AD
- Active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation
- History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
- Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
- Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years
- Current pregnancy or lactation, or intent to become pregnant during the study
- Known sensitivity to any of the components of the study drug
- Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
- Participated in a previous AN2728 clinical study
Data sourced from ClinicalTrials.gov (NCT01652885). 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. Informational only — not medical advice.