NCT04856930

Brief Summary

Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_2

Geographic Reach
4 countries

34 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2022

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

September 22, 2025

Completed
Last Updated

September 22, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

April 20, 2021

Results QC Date

April 29, 2025

Last Update Submit

September 2, 2025

Conditions

Hidradenitis Suppurativa

Keywords

IL-36 receptorInterleukin 36Imsidolimab

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, Week 16

Secondary Outcomes (8)

  • Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period

    Baseline, Week 16

  • Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period

    Week 16

  • Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period

    Baseline, Week 16

  • Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period

    Baseline, Week 16

  • Percent Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period

    Baseline, Week 16

  • +3 more secondary outcomes

Study Arms (3)

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

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

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.

Biological: Placebo

Interventions

ImsidolimabBIOLOGICAL

Humanized Monoclonal Antibody

Also known as: ANB019
Imsidolimab 200/100 mgImsidolimab 400/200 milligrams (mg)
PlaceboBIOLOGICAL

Placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \. Concomitant dermatological or medical conditions that may interfere with the Investigators' ability to evaluate the participant's response to therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Site 10-108

Birmingham, Alabama, 35224, United States

Location

Site 10-104

Fountain Valley, California, 92708, United States

Location

Site 10-119

Northridge, California, 91324, United States

Location

Site 10-102

Sacramento, California, 95817, United States

Location

Site 10-109

Coral Gables, Florida, 33134, United States

Location

Site 10-107

Largo, Florida, 33770, United States

Location

Site 10-111

Tampa, Florida, 33607, United States

Location

Site 10-110

Sandy Springs, Georgia, 30328, United States

Location

Site 10-101

Fort Gratiot, Michigan, 48059, United States

Location

Site 10-103

Portsmouth, New Hampshire, 03801, United States

Location

Site 10-115

Warwick, Rhode Island, 02886, United States

Location

Site 10-113

Greenville, South Carolina, 29615, United States

Location

Site 10-118

Houston, Texas, 77056, United States

Location

Site 10-112

Pflugerville, Texas, 78660, United States

Location

Site 10-117

San Antonio, Texas, 78213, United States

Location

Site 10-105

Norfolk, Virginia, 23502, United States

Location

Site 10-106

Spokane, Washington, 99202, United States

Location

Site 11-106

Calgary, Alberta, T2J7E1, Canada

Location

Site 11-103

Cobourg, Ontario, K9A 0Z4, Canada

Location

Site 11-102

Markham, Ontario, L3P 1X3, Canada

Location

Site 11-105

Québec, Quebec, G1N 4V3, Canada

Location

Site 11-101

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

Site 59-106

Batumi, 6000, Georgia

Location

Site 59-102

Tbilisi, 112, Georgia

Location

Site 59-104

Tbilisi, 159, Georgia

Location

Site 59-103

Tbilisi, 160, Georgia

Location

Site 59-105

Tbilisi, 160, Georgia

Location

Site 59-107

Tbilisi, 162, Georgia

Location

Site 30-107

Krakow, Malopolska, 30-074, Poland

Location

Site 30-104

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

Site 30-108

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Site 30-103

Ossy, Silesian Voivodeship, 42-624, Poland

Location

Site 30-109

Lodz, 90-265, Poland

Location

Site 30-106

Olsztyn, 10-229, Poland

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Results Point of Contact

Title
Vanda Pharmaceuticals
Organization
Vanda Pharmaceuticals
clinicaltrials@vandapharma.com
202-734-3400

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 23, 2021

Study Start

July 7, 2021

Primary Completion

July 15, 2022

Study Completion

December 14, 2022

Last Updated

September 22, 2025

Results First Posted

September 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(17)GE(6)CA(5)PL(6)