NCT04856917

Brief Summary

Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris

Trial Health

90
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2021

Shorter than P25 for phase_2

Geographic Reach
2 countries

15 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
22 days until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 15, 2023

Completed
Last Updated

September 22, 2025

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

April 20, 2021

Results QC Date

May 19, 2023

Last Update Submit

September 2, 2025

Conditions

Acne Vulgaris

Keywords

LI-36 ReceptorInterleukin 36Imsidolimab

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Facial Inflammatory Lesion Counts at Week 12

    The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.

    Baseline, Week 12

Secondary Outcomes (13)

  • Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20

    Baseline, Weeks 2, 4, 8, and 20

  • Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20

    Baseline, Weeks 2, 4, 8, 12 and 20

  • Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20

    Baseline, Weeks 2, 4, 8, 12, and 20

  • Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20

    Baseline, Weeks 2, 4, 8, 12, and 20

  • Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20

    Baseline, Weeks 2, 4, 8, 12, and 20

  • +8 more secondary outcomes

Study Arms (3)

Imsidolimab 400/200 mg

EXPERIMENTAL

Participants received imsidolimab 400 milligrams (mg) by subcutaneous (SC) injection on Day 1, followed by 200 mg on Days 29 and 57.

Drug: Imsidolimab

Imsidolimab 200/100 mg

EXPERIMENTAL

Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.

Drug: Imsidolimab

Placebo

PLACEBO COMPARATOR

Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.

Biological: Placebo

Interventions

ImsidolimabDRUG

Humanized Monoclonal Antibody

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

Placebo

Placebo

Eligibility Criteria

Age12 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • A participant with acne fulminans or conglobate or secondary acne will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Site 10-114

Hot Springs, Arkansas, 71913, United States

Location

Site 10-111

Fountain Valley, California, 92708, United States

Location

Site 10-106

Sherman Oaks, California, 91403, United States

Location

Site 10-113

Sweetwater, Florida, 33172, United States

Location

Site 10-108

Tampa, Florida, 33607, United States

Location

Site 10-107

Tampa, Florida, 33613, United States

Location

Site 10-109

New Orleans, Louisiana, 70119, United States

Location

Site 10-112

New Orleans, Louisiana, 70119, United States

Location

Site 10-104

Detroit, Michigan, 48202, United States

Location

Site 10-110

Portsmouth, New Hampshire, 03801, United States

Location

Site 10-105

Murfreesboro, Tennessee, 37130, United States

Location

Site 10-103

Austin, Texas, 78759, United States

Location

Site 10-102

College Station, Texas, 77845, United States

Location

Site 10-101

San Antonio, Texas, 78213, United States

Location

Site 10-115

Waterloo, Ontario, N2J1C4, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous 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

May 15, 2021

Primary Completion

February 1, 2022

Study Completion

March 29, 2022

Last Updated

September 22, 2025

Results First Posted

June 15, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(14)CA(1)