Phase 2
Completed N=172
A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
Source: ClinicalTrials.gov NCT03706040 ↗Enrolled (actual)
172
Serious AEs
2.6%
Results posted
Nov 2021
Primary outcomePrimary: Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16 — 11.8; 24.6; 21.7 percentage of participants — p=0.084
Summary
The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16 |
11.8; 24.6; 21.7 | 0.084 |
| SECONDARY Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 16 |
5.9; 14.5; 5.8 | 0.129 |
| SECONDARY Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 |
0; 13.6; 15.2 | 0.001 sig |
| SECONDARY Percent Change From Baseline in EASI Score at Week 16 |
-28.54; -38.86; -45.39 | 0.353 |
| SECONDARY Percent Change From Baseline in EASI Score at Week 28 and Week 52 |
-58.60; -59.81; -62.44; -63.77; -31.39; -76.75 | — |
| SECONDARY Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52 |
37.5; 0; 53.3; 41.9; 0; 75.0 | — |
| SECONDARY Percentage of Participants Who Achieved an EASI 50 Response at Week 16 |
29.4; 42.0; 34.8 | 0.171 |
| SECONDARY Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52 |
75.0; 80.0; 73.3; 74.4; 40.0; 75.0 | — |
| SECONDARY Percentage of Participants Who Achieved an EASI 90 Response at Week 16 |
2.9; 14.5; 8.7 | 0.022 sig |
| SECONDARY Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52 |
25.0; 0; 26.7; 27.9; 0; 0 | — |
| SECONDARY Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 28 and Week 52 |
0; 0; 22.2; 25.6; 0; 0 | — |
| SECONDARY Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16 |
-7.41; -13.64; -13.27 | 0.169 |
| SECONDARY Change From Baseline in Percentage of BSA Affected by Atopic Dermatitis at Weeks 28 and 52 |
-20.07; -11.90; -23.23; -23.22; -0.86; -30.23 | — |
| SECONDARY Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50) at Week 16 |
18.0; 24.6; 13.0 | 0.422 |
| SECONDARY Percentage of Participants Who Achieved a SCORAD 50 Response at Week 28 and Week 52 |
44.4; 20.0; 47.8; 37.2; 0; 50.0 | — |
| SECONDARY Percentage of Participants Who Achieved a SCORAD 75 Response at Week 16 |
0; 10.1; 2.9 | 0.005 sig |
| SECONDARY Percentage of Participants Who Achieved a SCORAD 75 Response at Week 28 and Week 52 |
11.1; 0; 23.9; 11.6; 0; 0 | — |
| SECONDARY Percentage of Participants Who Achieved a SCORAD 90 Response at Week 16 |
0; 5.8; 1.4 | 0.035 sig |
| SECONDARY Percentage of Participants Who Achieved a SCORAD 90 Response at Week 28 and Week 52 |
0; 0; 6.5; 4.7; 0; 0 | — |
| SECONDARY Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" at Week 16 |
9.0; 8.7; 5.8 | 0.965 |
| SECONDARY Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52 |
22.2; 20.0; 16.3; 13.6; 20.0; 25.0 | — |
| SECONDARY Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16 |
0; 0 | — |
| SECONDARY Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52 |
— | — |
| SECONDARY Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline at Week 16 Among Those With a DLQI ≥ 4 at Baseline |
25.6; 31.3; 37.5 | 0.539 |
| SECONDARY Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline at Week 28 and Week 52 Among Those With a DLQI ≥ 4 at Baseline |
77.8; 40.0; 66.7; 68.3; 60.0; 50.0 | — |
| SECONDARY Change From Baseline in DLQI Score at Week 16 |
-3.4; -3.4; -4.4 | 0.988 |
| SECONDARY Change From Baseline in DLQI Score at Week 28 and Week 52 |
-8.0; -5.3; -7.1; -7.3; -4.5; -5.0 | — |
| SECONDARY Change From Baseline in CDLQI Score at Week 16 |
-2.0 | — |
| SECONDARY Change From Baseline in CDLQI Score at Week 28 and Week 52 |
1.0 | — |
| SECONDARY Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16 |
-0.098; -1.416; -1.746 | 0.033 sig |
| SECONDARY Change From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52 |
-2.685; -3.182; -2.474; -2.684; -2.668; -4.012 | — |
| SECONDARY Percentage of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52 |
22.2; 20.0; 31.3; 39.5; 20.0; 25.0 | — |
Eligibility Criteria
Inclusion Criteria
- adults who are ≥ 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old
- a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria
- moderate to severe AD at the Baseline Visit
- history of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments
Exclusion Criteria
- prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor
- concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments
Data sourced from ClinicalTrials.gov (NCT03706040). 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.