Phase 2
Completed N=270
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis
Source: ClinicalTrials.gov NCT00717769 ↗Enrolled (actual)
270
Serious AEs
1.1%
Results posted
Apr 2021
Primary outcomePrimary: Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis — 12.59; 12.45; 6.01; 3.0 score on a scale
Summary
The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult participants with atopic dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis |
12.59; 12.45; 6.01; 3.0; 3.1; 2.6 | — |
| PRIMARY Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis |
-1.94; -2.36; -3.28; -5.13; -4.26; -7.08 | 0.533 |
| PRIMARY Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis |
-13.65; -16.03; -23.67; -33.64; -29.29; -44.40 | — |
| SECONDARY Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis |
-0.2; -0.2; -0.4; -0.7; -0.5; -1.0 | — |
| SECONDARY Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis |
-7.06; -7.33; -11.09; -20.23; -16.02; -30.47 | — |
| SECONDARY Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis |
-0.3; -0.3; -0.5; -0.7; -0.6; -0.7 | — |
| SECONDARY Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis |
-10.03; -7.45; -17.92; -23.45; -20.25; -22.61 | — |
| SECONDARY Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis |
-0.6; -0.7; -0.7; -1.3; -0.6; -1.4 | — |
| SECONDARY Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis |
0.747; 0.100; 93.7; 741; 87.7; 508 | — |
| SECONDARY Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis |
0.500; 0.500; 7.59; 32.9; 8.01; 41.7 | — |
| SECONDARY Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis |
82; 68; 14; 1; 2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female participants between 18 and 65 years of age.
- A diagnosis of Atopic Dermatitis (AD), meeting the Guidelines for Diagnosis of Atopic Dermatitis criteria
- At least 1 inflammatory lesion Eczema Area and Severity Index (EASI) score ≥5 at Screening and prior to randomization (as per Amendment 2 and 3). Under the original protocol and Amendment 1, no minimum EASI score was required.
Exclusion Criteria
- Taking systemic immunosuppressive drugs or biologicals (within 3 months), or systemic corticosteroids therapy (within 4 weeks)prior to Screening(note: inhaled, intranasal or otic corticosteroids are allowed).
- Use of phototherapy or tanning beds within 6 weeks of screening
- History of reactive airway disease (asthma) requiring hospitalization in an intensive care unit in the last 5 years.
- Presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the Clinical Investigator) that will interfere with the interpretation of data from this patient (eg, renal impairment with non-atopic pruritus).
Data sourced from ClinicalTrials.gov (NCT00717769). 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.