Phase 2
Completed N=64
To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis
Source: ClinicalTrials.gov NCT02683928 ↗Enrolled (actual)
64
Serious AEs
1.6%
Results posted
May 2020
Primary outcomePrimary: Incidence of Treatment-Emergent Adverse Events — 29; 10; 1; 0 Participants
Summary
The purpose of this study is to determine the effect of GBR 830 on biomarkers in atopic dermatitis to enable further studies in this indication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-Emergent Adverse Events |
29; 10; 1; 0; 2; 1 | — |
| PRIMARY Change From Baseline in Thickness of Lesional Skin Biopsies |
140.56; 124.95; -14.90; -3.02; -26.51; -6.01 | — |
| PRIMARY Change From Baseline in Ratio of Active Atopic Dermatitis Messenger Ribonucleic Acid (mRNA) Expression (Normalized to Human Acidic Ribosomal Protein [hARP]) in Lesional Skin Biopsies |
0.67; 1.20; 0.62; 0.75; 0.75; 0.64 | — |
| SECONDARY Percent Change in Eczema Area and Severity Index (EASI) Clinical Scores From Baseline |
-9.80; -11.33; -38.72; -32.40; -61.00; -39.54 | — |
| SECONDARY Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Clinical Score of 0 or 1 |
0; 0; 2; 0; 6; 2 | — |
| SECONDARY Pharmacokinetics of GBR 830 in Terms of Cmax After First and Second Dose. |
303; 352 | — |
| SECONDARY Pharmacokinetics of GBR 830 in Terms of AUC0-tau After the First and Second Dose. |
57217; 69670 | — |
| SECONDARY Number of Participants Positive or Negative for Anti-drug Antibodies (ADA) to GBR 830 to Evaluate Immunogenicity |
6; 1; 40; 15 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 years or older
- Atopic dermatitis involvement that of at least 10% body surface area
Exclusion Criteria
- Treatment with systemic corticosteroids within 4 weeks before randomization, and topical steroids, tacrolimus and/or pimecrolimus within 1 week before the randomization (except emollients, and mild steroids (class 6 or 7)
- Any cell-depleting agents including but not limited to rituximab: within 6 months prior to the baseline visit or until lymphocyte and CD 19+ lymphocyte counts return to normal, whichever is longer. Other biologics: within 5 half-lives or 8 weeks prior to the baseline visit, whichever is longer. Allergen immunotherapy within 6 months before the baseline visit.
- Patient with history of serious local infection and systemic infection Patient with history or current evidence of diseases such as tuberculosis, malignant disease, other inflammatory or autoimmune disease or HIV or Hepatitis B or C positive.
Data sourced from ClinicalTrials.gov (NCT02683928). 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.