An Efficacy and Safety Study of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis
Summary
The purpose of this study is to evaluate the safety and effectiveness of four dose regimens (pattern of giving treatment) of JNJ-26113100 in the treatment of adult Atopic Dermatitis (\[AD\]; skin rash, inflammation) that is moderate in severity.
Timeline
- Start
- 2007-04
- Primary completion
- 2009-03
- Completion
- 2009-03
Outcome
Missed primary endpoint
Stopped: “The study was stopped due to a non-clinical safety finding.”
registry analysis (superiority or other test); Placebo vs JNJ-26113100 (50 mg) Once Daily; p = 0.600; Cochran-Mantel-Haenszel NCT00455429 ↗
registry analysis (superiority or other test); Placebo vs JNJ-26113100 (50 mg) Once Daily; p = 0.427; LS Mean difference -3.4 (95% CI -9.70 to 2.90); Dunnett-Hsu NCT00455429 ↗
registry analysis (superiority or other test); Placebo vs JNJ-26113100 (50 mg) Once Daily; p = 0.941; LS Mean difference 3.7 (95% CI -15.83 to 23.18); Dunnett-Hsu NCT00455429 ↗
registry analysis (superiority or other test); Placebo vs JNJ-26113100 (50 mg) Once Daily; p = 0.460; Regression, Logistic NCT00455429 ↗
registry analysis (superiority or other test); Placebo vs JNJ-26113100 (50 mg) Once Daily; p = 0.363; Regression, Logistic NCT00455429 ↗
registry analysis (superiority or other test); Placebo vs JNJ-26113100 (50 mg) Once Daily; p = 0.333; Regression, Logistic NCT00455429 ↗
registry analysis (superiority or other test); Placebo vs JNJ-26113100 (50 mg) Once Daily; p = 0.631; Regression, Logistic NCT00455429 ↗
registry analysis (superiority or other test); Placebo vs JNJ-26113100 (50 mg) Once Daily; p = 0.429; Regression, Logistic NCT00455429 ↗
registry analysis (superiority or other test); Placebo vs JNJ-26113100 (50 mg) Once Daily; p = 0.097; Regression, Logistic NCT00455429 ↗
registry analysis (superiority or other test); Placebo vs JNJ-26113100 (50 mg) Once Daily; p = 0.566; Regression, Logistic NCT00455429 ↗
registry analysis (superiority or other test); Placebo vs JNJ-26113100 (50 mg) Once Daily; p = 0.206; Regression, Logistic NCT00455429 ↗
registry analysis (superiority or other test); Placebo vs JNJ-26113100 (50 mg) Once Daily; p = 0.484; Regression, Logistic NCT00455429 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JNJ-26113100 | Unknown | 50 mg | Oral |
| Subject | JNJ-26113100 | Unknown | 100 mg | Oral |
| Subject | JNJ-26113100 | Unknown | 250 mg | Oral |