Phase 2
Completed N=462
Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis
Moderate to Severe Atopic Dermatitis
Source: ClinicalTrials.gov NCT03568162 ↗
Enrolled (actual)
462
Serious AEs
3.4%
Results posted
Jun 2022
Primary outcomePrimary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Clinical Score at Week 16 — -57.589; -56.734; -38.099; -42.142 percentage change — p== 0.008
Summary
Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a 16 week blinded treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Clinical Score at Week 16 |
-57.589; -56.734; -38.099; -42.142; -59.737; -43.252 | = 0.008 sig |
| SECONDARY Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 16 |
23.7; 20.5; 11.7; 11.3; 25.3; 18.9 | — |
| SECONDARY Percentage of Participants Achieving Both Investigator's Global Assessment (IGA) Clinical Score of 0 or 1 and an IGA Reduction From Baseline of ≥ 2 Points at Week 16 |
13.2; 10.3; 6.5; 5.0; 12.0; 5.4 | — |
| SECONDARY Percentage of Participants With Improvement (Reduction) in Pruritus Numerical Rating Scale (NRS) Score of ≥ 4 From Baseline at Week 16 |
7.9; 11.5; 5.2; 10.0; 13.3; 9.5 | — |
| SECONDARY Percentage of Participants Achieving a 50% Reduction From Baseline in EASI Score (EASI-50) at Week 16 |
48.7; 34.6; 27.3; 27.5; 44.0; 33.8 | — |
| SECONDARY Percent Change From Baseline in SCORAD Score at Week 16 |
-26.519; -26.108; -18.405; -19.440; -27.401; -18.847 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 |
15.2; 15.4; 14.3; 14.3; 14.1; 14.7 | — |
| SECONDARY Change From Baseline in Global Individual Signs Score (GISS) at Week 16 |
9.1; 9.4; 9.1; 8.9; 9.0; 8.9 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale Scores at Week 16 |
6.1; 6.1; 6.1; 6.2; 6.0; 6.7 | — |
| SECONDARY Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 16 |
20.2; 20.9; 19.8; 21.2; 20.7; 21.1 | — |
| SECONDARY Change From Baseline in Patient Global Assessment (PGA) of Disease and Treatment at Week 16 |
2.0; 1.9; 2.1; 1.9; 2.0; 2.1 | — |
| SECONDARY Percentage Change From Baseline in PGA of Disease and Treatment at Week 16 |
72.2; 73.3; 33.3; 76.2; 69.2; 40.4 | — |
| SECONDARY Number of Missed Work or School Days at Week 16 |
1.2; 0.5; 0.5; 0.5; 4.9; 1.4 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of ISB 830 |
46.98; 49.95; 16.62; 92.84; 52.33; 31.20 | — |
| SECONDARY Area Under Curve From Time Zero to the End of Dosing Interval (AUC0-tau) |
12170; 20340; 6671; 26930; 12990; 13120 | — |
| SECONDARY Percentage of Participants With Anti-Drug Antibody (ADA) at Week 16 |
13.3; 29.9; 50.6; 5.1; 10.7; 6.8 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects aged ≥18 years with physician diagnosis of atopic dermatitis for >1 year as defined by American Academy of Dermatology Consensus Criteria.
- Atopic dermatitis involvement of ≥10% of body surface area at screening and baseline.
- EASI score of ≥12 at screening or ≥16 at baseline.
- IGA score of ≥3 at screening and baseline (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe)
- Baseline Pruritus Numerical Rating Scale (NRS) score for maximum itch intensity ≥3 over the previous 24 hours.
Exclusion Criteria
- Pregnant or lactating women.
- Prior treatment with ISB 830
- Treatment with biologics
- Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy within 4 weeks of baseline
- Active chronic or acute infection requiring systemic treatment
Data sourced from ClinicalTrials.gov (NCT03568162). 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.