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A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa
Phase 2 trial testing Imsidolimab in Hidradenitis Suppurativa in 149 participants. Completed in 14 December 2022.
| Lead sponsor | Vanda Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 149 |
| Start date | 7 July 2021 |
| Primary completion | 15 July 2022 |
| Estimated completion | 14 December 2022 |
| Sites | 34 locations across Georgia, Canada, United States, Poland |
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Adults 18 to 75, any sex, with Hidradenitis Suppurativa. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
| Group | Value | 95% CI |
|---|---|---|
| Placebo-Controlled Period: Imsidolimab 400/200 mg | -5.9 | ± 6.05 |
| Placebo-Controlled Period: Imsidolimab 200/100 mg | -4.1 | ± 4.63 |
| Placebo-Controlled Period: Placebo | -5.6 | ± 7.40 |
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
| Group | Value | 95% CI |
|---|---|---|
| Placebo-Controlled Period: Imsidolimab 400/200 mg | -44.7 | ± 39.23 |
| Placebo-Controlled Period: Imsidolimab 200/100 mg | -36.7 | ± 36.59 |
| Placebo-Controlled Period: Placebo | -41.2 | ± 43.69 |
The number of participants with at least a 50% decrease from Baseline AN count, and no increase in abscesses or draining fistulas in comparison to baseline (HiSCR50) at Week 16 was calculated for each treatment group as follows: A responder HiSCR50 was defined as a participant with 1. at least a 50% decrease in AN count from Baseline, and 2. no increase in abscess count relative to Baseline, and 3. no increase in draining fistula count relative to Baseline
| Group | Value | 95% CI |
|---|---|---|
| Placebo-Controlled Period: Imsidolimab 400/200 mg | 16 | |
| Placebo-Controlled Period: Imsidolimab 200/100 mg | 16 | |
| Placebo-Controlled Period: Placebo | 15 |
Participants were asked to assign a numerical score representing the HS worst pain intensity over the last 24 hours on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).
| Group | Value | 95% CI |
|---|---|---|
| Placebo-Controlled Period: Imsidolimab 400/200 mg | -0.3 | ± 2.89 |
| Placebo-Controlled Period: Imsidolimab 200/100 mg | -0.7 | ± 2.37 |
| Placebo-Controlled Period: Placebo | -0.4 | ± 3.22 |
Participants were asked to assign a numerical score representing the average intensity over the last 7 days of their HS pain symptoms on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).
| Group | Value | 95% CI |
|---|---|---|
| Placebo-Controlled Period: Imsidolimab 400/200 mg | -0.5 | ± 2.29 |
| Placebo-Controlled Period: Imsidolimab 200/100 mg | -1.0 | ± 2.48 |
| Placebo-Controlled Period: Placebo | -0.5 | ± 2.74 |
Participants were asked to assign a numerical score representing the HS worst pain intensity over the last 24 hours on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms). Only participants that had Baseline score of \>0 could be included in the analysis of Percent Change from Baseline.
| Group | Value | 95% CI |
|---|---|---|
| Placebo-Controlled Period: Imsidolimab 400/200 mg | 7.6 | ± 81.81 |
| Placebo-Controlled Period: Imsidolimab 200/100 mg | 10.2 | ± 146.92 |
| Placebo-Controlled Period: Placebo | 30.3 | ± 136.89 |
Participants were asked to assign a numerical score representing the average intensity over the last 7 days of their HS pain symptoms on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms). Only participants that had Baseline score of \>0 could be included in the analysis of Percent Change from Baseline.
| Group | Value | 95% CI |
|---|---|---|
| Placebo-Controlled Period: Imsidolimab 400/200 mg | -1.3 | ± 58.54 |
| Placebo-Controlled Period: Imsidolimab 200/100 mg | -18.3 | ± 37.76 |
| Placebo-Controlled Period: Placebo | 4.5 | ± 77.25 |
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment during placebo-controlled period, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Placebo-Controlled Period: Imsidolimab 400/200 mg | 19 | |
| Placebo-Controlled Period: Imsidolimab 200/100 mg | 14 | |
| Placebo-Controlled Period: Placebo | 18 |
An AE was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment in extension period, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Extension Period: Imsidolimab 400/200 mg | 15 | |
| Extension Period: Imsidolimab 200/100 mg | 18 | |
| Extension Period: Placebo to Imsidolimab 400/200 mg | 9 | |
| Extension Period: Placebo to Imsidolimab 200/100 mg | 10 |
Time frame: From first dose up to Week 40. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo-Controlled Period:… | Placebo-Controlled Period:… | Placebo-Controlled Period:… | Extension Period: Imsidoli… | Extension Period: Imsidoli… | Extension Period: Placebo … | Extension Period: Placebo … |
|---|---|---|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | — | — | — | — | — | — | — |
| Abscess limb | Infections and infestations | — | — | — | — | — | — | — |
| Hidradenitis | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | — | — | — | — | — | — | — |
| Reaction | System | Placebo-Controlled Period:… | Placebo-Controlled Period:… | Placebo-Controlled Period:… | Extension Period: Imsidoli… | Extension Period: Imsidoli… | Extension Period: Placebo … | Extension Period: Placebo … |
|---|---|---|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | — | — | — | — | — | — | — |
| Hidradenitis | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — |
| Dermatitis contact | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — |
| Sinusitis | Infections and infestations | — | — | — | — | — | — | — |
| Acne | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — |
| Intertrigo | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — | — | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Adjustment disorder | Psychiatric disorders | — | — | — | — | — | — | — |
| Alopecia areata | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — |
| Bronchitis | Infections and infestations | — | — | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Joint swelling | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — |
| Night sweats | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — |
| Pollakiuria | Renal and urinary disorders | — | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — | — | — | — |
| Sinus tachycardia | Cardiac disorders | — | — | — | — | — | — | — |
Most-reported serious reactions: COVID-19, Abscess limb, Hidradenitis, Abortion spontaneous.
Data from ClinicalTrials.gov NCT04856930 adverse events section.
Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa
8 peer-reviewed publications reference this trial (live from Europe PMC):
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