Phase 2
N=123
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT04856917 ↗Enrolled (actual)
123
Serious AEs
0.8%
Results posted
Jun 2023
Primary outcome: Primary: Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 — -6.8; -7.4; -9.6 lesions — p=0.3757
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Imsidolimab (Drug); Placebo (Biological)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Vanda Pharmaceuticals
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 |
-6.8; -7.4; -9.6 | 0.3757 |
| SECONDARY Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 |
-1.9; -0.5; -3.8; -0.3; -4.4; -8.0 | 0.2490 |
| SECONDARY Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 |
-6.6; -1.9; -13.6; -2.9; -14.1; -29.3 | 0.3008 |
| SECONDARY Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 |
-2.2; -0.9; -3.2; -4.7; -4.3; -6.4 | 0.4229 |
| SECONDARY Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 |
-1.0; 1.0; 1.1; -6.8; -8.7; -12.7 | 0.9679 |
| SECONDARY Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 |
-4.1; -1.3; -7.0; -5.0; -8.7; -14.4 | 0.2150 |
| SECONDARY Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 |
-6.9; -1.9; -10.7; -7.7; -13.5; -23.2 | 0.4361 |
| SECONDARY Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 |
-0.2; -0.0; -0.2; -0.2; -0.1; -0.5 | 0.5157 |
| SECONDARY Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20 |
0; 0; 0; 0; 0; 2.6 | 0.3390 |
| SECONDARY Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 |
0; 0; 0; 25.0; 23.7; 21.1 | 0.4482 |
| SECONDARY Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20 |
0; 0; 0; 5.0; 2.6; 2.6 | 0.8338 |
| SECONDARY Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20 |
-1.6; -1.9; -2.0; -2.6; -3.6; -2.3 | 0.7932 |
| SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20 |
-1.6; -0.7; -2.0; -0.3; -2.7; -2.6 | 0.9333 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
18; 10; 11; 1; 0; 0 | — |
Summary
Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris
Eligibility Criteria
Key Inclusion Criteria
- Diagnosis of moderate to severe facial AV
- Facial IGA) score of 3 (moderate) or 4 (severe)
- At least 20 and no more than 100 inflammatory lesions on the face
- No more than 100 non-inflammatory lesions on the face.
- No more than 5 nodules (≥5 millimeter [mm]) on the face
Key Exclusion Criteria
- A participant with acne fulminans or conglobate or secondary acne will be excluded.
Data sourced from ClinicalTrials.gov (NCT04856917). 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.