Phase 2
Completed N=370
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Source: ClinicalTrials.gov NCT01756898 ↗Enrolled (actual)
370
Serious AEs
0.3%
Results posted
Feb 2021
Primary outcomePrimary: Number of Investigator's Global Assessment (IGA) Responders at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis — 20; 21; 19; 18 Participants
Summary
The purpose of this research study is to gather scientific information about the effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult subjects with atopic dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Investigator's Global Assessment (IGA) Responders at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis |
20; 21; 19; 18 | — |
| PRIMARY Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis |
1; 3; 7; 7; 19; 18 | — |
| SECONDARY Mean Change From Baseline in Eczema Area and Severity Index Score (EASI) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29 |
12.6; 12.2; 11.2; 11.7; -3.43; -3.24 | — |
| SECONDARY Mean Change From Baseline in The Percentage of Body Surface Area (BSA) Involved Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29 |
21.0; 19.6; 18.5; 18.1; -3.59; -2.99 | — |
| SECONDARY Mean Change From Baseline in Pruritus Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29 |
2.3; 2.4; 2.2; 2.5; -0.75; -0.80 | — |
| SECONDARY Mean Change From Baseline in Insomnia Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29 |
4.0; 3.9; 3.7; 3.6; -1.10; -1.06 | — |
| SECONDARY Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis |
NA; NA; NA; 24.4; 48.3; 89.6 | — |
| SECONDARY Minimum Observed Plasma Concentration (Cmin) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis |
0.88; 1.34; 2.43; 0.58; 0.97; 1.82 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Subjects With Atopic Dermatitis |
33.82; 67.60; 134.90; 11.27; 22.25; 42.73 | — |
| SECONDARY Average Plasma Concentration (Cavg) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis |
5.59; 11.04; 21.88; 2.16; 4.18; 8.30 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis |
0; 2; 3; 1; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult subjects ages 18 to 65 years
- A diagnosis of atopic dermatitis (AD)
- An Investigator's Global Assessment (IGA) score of 2 or higher and AD affecting at least 5% of total Body Surface Area (BSA)
- Other than active AD, in good health with no medical condition that may jeopardize the safety of the subject or impact the validity of the study results
- Subjects must be practicing acceptable birth control methods
Exclusion Criteria
- Taking systemic immunosuppressive therapy within 3 months prior to screening or systemic (cortico) steroid therapy within 4 weeks prior to screening
- Use of phototherapy or tanning beds within 6 weeks of screening
- Presence of a clinically significant disorder involving gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition, which will jeopardize the safety of the subject or impact the validity of the study results
- Female subjects who are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT01756898). 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.