Trial · NCT04856930
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa
NCT04856930, Phase 2, Completed, Vanda Pharmaceuticals; results first posted 2025-09-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa. Trials, record NCT04856930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04856930
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa
- NCT number
- NCT04856930
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 149 participants, actual
- Lead sponsor
- Vanda Pharmaceuticals
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Imsidolimab, Placebo
- First posted
- 2021-04-23
- Last updated
- 2025-09-22
- Other registries' IDs
- eudract:2021-001440-99
- Results first posted
- 2025-09-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in AN Count at Week 16: Placebo-Controlled Period | Baseline, Week 16 | The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations. |
| Secondary | Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period | Baseline, Week 16 | The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations. |
| Secondary | Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period | Week 16 | 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 |
| Secondary | Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period | Baseline, Week 16 | 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). |
| Secondary | Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period | Baseline, Week 16 | 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). |
| Secondary | Percent Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period | Baseline, Week 16 | 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. |
| Secondary | Percent Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period | Baseline, Week 16 | 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. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs): Placebo-Controlled Period | From first dose (placebo-controlled period) up to Week 16 | 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. |
| Secondary | Number of Participants With TEAEs: Extension and Follow-up Period | From first dose (extension period) up to Week 40 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in AN Count at Week 16: Placebo-Controlled Period | Baseline, Week 16 | ITT Analysis Set with available data was analyzed. | count of abscess and inflammatory nodule | MEAN |
| SECONDARY | Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period | Baseline, Week 16 | ITT Analysis Set with available data was analyzed. | percent change | MEAN |
| SECONDARY | Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period | Week 16 | ITT Analysis Set with available data was analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period | Baseline, Week 16 | ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period | Baseline, Week 16 | ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline. | units on a scale | MEAN |
| SECONDARY | Percent Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period | Baseline, Week 16 | ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline. Overall number of participants analyzed included only those participants with Baseline score of \>0. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period | Baseline, Week 16 | ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline. Overall number of participants analyzed included only those participants with Baseline score of \>0. | percent change | MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs): Placebo-Controlled Period | From first dose (placebo-controlled period) up to Week 16 | Safety analysis set included all randomized participants who received at least 1 dose of imsidolimab or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs: Extension and Follow-up Period | From first dose (extension period) up to Week 40 | Extension Analysis Set included subset of the safety analysis set who received at least 1 dose of imsidolimab in the extension period. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in AN Count at Week 16: Placebo-Controlled Period | Placebo-Controlled Period: Imsidolimab 400/200 mg | -5.9 | Standard Deviation 6.05 | count of abscess and inflammatory nodule | |
| Change From Baseline in AN Count at Week 16: Placebo-Controlled Period | Placebo-Controlled Period: Imsidolimab 200/100 mg | -4.1 | Standard Deviation 4.63 | count of abscess and inflammatory nodule | |
| Change From Baseline in AN Count at Week 16: Placebo-Controlled Period | Placebo-Controlled Period: Placebo | -5.6 | Standard Deviation 7.40 | count of abscess and inflammatory nodule | |
| Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period | Placebo-Controlled Period: Imsidolimab 400/200 mg | -44.7 | Standard Deviation 39.23 | percent change | |
| Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period | Placebo-Controlled Period: Imsidolimab 200/100 mg | -36.7 | Standard Deviation 36.59 | percent change | |
| Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period | Placebo-Controlled Period: Placebo | -41.2 | Standard Deviation 43.69 | percent change | |
| Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period | Placebo-Controlled Period: Imsidolimab 400/200 mg | 16 | Participants | ||
| Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period | Placebo-Controlled Period: Imsidolimab 200/100 mg | 16 | Participants | ||
| Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period | Placebo-Controlled Period: Placebo | 15 | Participants | ||
| Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period | Placebo-Controlled Period: Imsidolimab 400/200 mg | -0.3 | Standard Deviation 2.89 | units on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-controlled Period (16 Weeks) | STARTED | Imsidolimab 400/200 mg | 50 | |
| Placebo-controlled Period (16 Weeks) | STARTED | Imsidolimab 200/100 mg | 50 | |
| Placebo-controlled Period (16 Weeks) | STARTED | Placebo | 49 | |
| Placebo-controlled Period (16 Weeks) | COMPLETED | Imsidolimab 400/200 mg | 41 | |
| Placebo-controlled Period (16 Weeks) | COMPLETED | Imsidolimab 200/100 mg | 42 | |
| Placebo-controlled Period (16 Weeks) | COMPLETED | Placebo | 43 | |
| Placebo-controlled Period (16 Weeks) | NOT COMPLETED | Imsidolimab 400/200 mg | 9 | |
| Placebo-controlled Period (16 Weeks) | NOT COMPLETED | Imsidolimab 200/100 mg | 8 | |
| Placebo-controlled Period (16 Weeks) | NOT COMPLETED | Placebo | 6 | |
| Extension Period (16 Weeks) | STARTED | Imsidolimab 400/200 mg | 41 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events203
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Placebo-Controlled Period: Imsidolimab 400/200 mg | 4 | 50 | 4 |
| other | COVID-19 | Infections and infestations | Placebo-Controlled Period: Imsidolimab 200/100 mg | 3 | 50 | 3 |
| other | COVID-19 | Infections and infestations | Placebo-Controlled Period: Placebo | 3 | 49 | 3 |
| other | COVID-19 | Infections and infestations | Extension Period: Imsidolimab 400/200 mg | 2 | 40 | 2 |
| other | COVID-19 | Infections and infestations | Extension Period: Imsidolimab 200/100 mg | 3 | 42 | 3 |
| other | COVID-19 | Infections and infestations | Extension Period: Placebo to Imsidolimab 400/200 mg | 0 | 19 | 0 |
| other | COVID-19 | Infections and infestations | Extension Period: Placebo to Imsidolimab 200/100 mg | 3 | 21 | 3 |
| other | Hidradenitis | Skin and subcutaneous tissue disorders | Placebo-Controlled Period: Imsidolimab 400/200 mg | 1 | 50 | 1 |
| other | Hidradenitis | Skin and subcutaneous tissue disorders | Placebo-Controlled Period: Imsidolimab 200/100 mg | 3 | 50 | 3 |
| other | Hidradenitis | Skin and subcutaneous tissue disorders | Placebo-Controlled Period: Placebo | 4 | 49 | 6 |
1 to 10 of 203Source ClinicalTrials.gov
See all 203 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo-Controlled Period: Imsidolimab 400/200 mg | 0 | 50 |
| Total, all-cause mortality | Placebo-Controlled Period: Imsidolimab 200/100 mg | 0 | 50 |
| Total, all-cause mortality | Placebo-Controlled Period: Placebo | 0 | 49 |
| Total, all-cause mortality | Extension Period: Imsidolimab 400/200 mg | 0 | 40 |
| Total, all-cause mortality | Extension Period: Imsidolimab 200/100 mg | 0 | 42 |
| Total, all-cause mortality | Extension Period: Placebo to Imsidolimab 400/200 mg | 0 | 19 |
| Total, all-cause mortality | Extension Period: Placebo to Imsidolimab 200/100 mg | 0 | 21 |
| Total, other adverse events | Placebo-Controlled Period: Imsidolimab 400/200 mg | 5 | 50 |
| Total, other adverse events | Placebo-Controlled Period: Imsidolimab 200/100 mg | 6 | 50 |
| Total, other adverse events | Placebo-Controlled Period: Placebo | 9 | 49 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04856930
GET https://conductscience.org/api/trials/v1/NCT04856930/results?page=2