Hidradenitis SuppurativaPhase 2NCT04856930
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa
A Phase 2 study testing Imsidolimab in people with Hidradenitis Suppurativa, run by Vanda Pharmaceuticals at 34 sites in 4 countries.
Trial summary
Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Imsidolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 34 sitesin 4 countries
- Study dates
- 7 Jul 2021to 14 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically confirmed diagnosis of active HS with a disease duration of greater than or equal to (≥) 6 months before Day 1.
- HS lesions present in at least 2 distinct anatomical areas.
- Total Abscess and inflammatory nodule (AN) count ≥ 5.
- Draining fistulas less than or equal to (≤) 20.
- Stable HS for at least 6 weeks prior to Day 1 visit.
Who cannot join
- 1. Concomitant dermatological or medical conditions that may interfere with the Investigators' ability to evaluate the participant's response to therapy.
Trial locations and contacts
34 sites in 4 countries.
34 sites in 4 countries
United States17 sites
Site 10-108
Birmingham, Alabama, 35224
Site 10-109
Coral Gables, Florida, 33134
Site 10-101
Fort Gratiot, Michigan, 48059
Site 10-104
Fountain Valley, California, 92708
Site 10-113
Greenville, South Carolina, 29615
Site 10-118
Houston, Texas, 77056
Site 10-107
Largo, Florida, 33770
Site 10-105
Norfolk, Virginia, 23502
Site 10-119
Northridge, California, 91324
Site 10-112
Pflugerville, Texas, 78660
Site 10-103
Portsmouth, New Hampshire, 03801
Site 10-102
Sacramento, California, 95817
Site 10-117
San Antonio, Texas, 78213
Site 10-110
Sandy Springs, Georgia, 30328
Site 10-106
Spokane, Washington, 99202
Site 10-111
Tampa, Florida, 33607
Site 10-115
Warwick, Rhode Island, 02886
Georgia6 sites
Site 59-106
Batumi, 6000
Site 59-102
Tbilisi, 112
Site 59-104
Tbilisi, 159
Site 59-103
Tbilisi, 160
Site 59-105
Tbilisi, 160
Site 59-107
Tbilisi, 162
Poland6 sites
Site 30-108
Katowice, Silesian Voivodeship, 40-611
Site 30-107
Krakow, Malopolska, 30-074
Site 30-109
Lodz, 90-265
Site 30-106
Olsztyn, 10-229
Site 30-103
Ossy, Silesian Voivodeship, 42-624
Site 30-104
Rzeszów, Podkarpackie Voivodeship, 35-055
Canada5 sites
Site 11-106
Calgary, Alberta, T2J7E1
Site 11-103
Cobourg, Ontario, K9A 0Z4
Site 11-102
Markham, Ontario, L3P 1X3
Site 11-105
Québec, Quebec, G1N 4V3
Site 11-101
Saint-Jérôme, Quebec, J7Z 7E2
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa
Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa
Read the detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adult participants with hidradenitis suppurativa (HS). This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with HS.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Imsidolimab, Placebo
- Keywords
- IL-36 receptor, Interleukin 36, Imsidolimab
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImsidolimabBiological
Also called ANB019
Humanized Monoclonal Antibody
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Imsidolimab 400/200 milligrams (mg) | Experimental | 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks Receives: Biological: Imsidolimab |
| Imsidolimab 200/100 mg | Experimental | 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks Receives: Biological: Imsidolimab |
| Placebo | Placebo comparator | Placebo-controlled period: Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in AN Count at Week 16: Placebo-Controlled Period
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
Measured: Baseline, Week 16
Secondary outcomes (8)
Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
Measured: Baseline, Week 16
Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period
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
- at least a 50% decrease in AN count from Baseline, and
- no increase in abscess count relative to Baseline, and
- no increase in draining fistula count relative to Baseline
Measured: Week 16
Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period
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).
Measured: Baseline, Week 16
Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period
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).
Measured: Baseline, Week 16
Percent Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period
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.
Measured: Baseline, Week 16
Percent Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period
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.
Measured: Baseline, Week 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs): Placebo-Controlled Period
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.
Measured: From first dose (placebo-controlled period) up to Week 16
Number of Participants With TEAEs: Extension and Follow-up Period
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.
Measured: From first dose (extension period) up to Week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start7 Jul 2021
- Primary completion15 Jul 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856930
- Sponsor's protocol ID
- ANB019-208
- Other IDs
- 2021-001440-99
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2021
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT04856930
- Acronym / sponsor ID
- ANB019-208
- Conditions
- Hidradenitis Suppurativa
- Keywords
- IL-36 receptor, Interleukin 36, Imsidolimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa
Detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adult participants with hidradenitis suppurativa (HS). This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with HS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Imsidolimab 400/200 milligrams (mg) | Experimental | Biological: Imsidolimab400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks |
| Imsidolimab 200/100 mg | Experimental | Biological: Imsidolimab400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo-controlled period: Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16). Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197). After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically confirmed diagnosis of active HS with a disease duration of greater than or equal to (≥) 6 months before Day 1.
- HS lesions present in at least 2 distinct anatomical areas.
- Total Abscess and inflammatory nodule (AN) count ≥ 5.
- Draining fistulas less than or equal to (≤) 20.
- Stable HS for at least 6 weeks prior to Day 1 visit.
Key exclusion criteria (1 listed)
- 1. Concomitant dermatological or medical conditions that may interfere with the Investigators' ability to evaluate the participant's response to therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImsidolimabAlso: ANB019Humanized Monoclonal Antibody | Biological | Imsidolimab 200/100 mg, Imsidolimab 400/200 milligrams (mg) |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Change From Baseline in AN Count at Week 16: Placebo-Controlled Period
Time frame: Baseline, Week 16
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
8 secondary outcomes
Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period
Time frame: Baseline, Week 16
Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period
Time frame: Week 16
Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period
Time frame: Baseline, Week 16
Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period
Time frame: Baseline, Week 16
Percent Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period
Time frame: Baseline, Week 16
Percent Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period
Time frame: Baseline, Week 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs): Placebo-Controlled Period
Time frame: From first dose (placebo-controlled period) up to Week 16
Number of Participants With TEAEs: Extension and Follow-up Period
Time frame: From first dose (extension period) up to Week 40
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
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Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
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A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
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Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
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ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imsidolimab in people with Hidradenitis Suppurativa, run by Vanda Pharmaceuticals at 34 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Georgia, Poland, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in AN Count at Week 16: Placebo-Controlled Period (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.