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Monoclonal Antibodies

Imsidolimab for Acne

Phase 2
Waitlist Available
Research Sponsored by AnaptysBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 2, 4, 8, 12 and 20
Awards & highlights

Study Summary

Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 2, 4, 8, 12 and 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 2, 4, 8, 12 and 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
Secondary outcome measures
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20
+10 more

Side effects data

From 2021 Phase 2 trial • 8 Patients • NCT03619902
25%
Oropharyngeal pain
13%
Nosocomial infection
13%
Anaemia
13%
Psoriasis
13%
Skin haemorrhage
13%
Lymphadenopathy
13%
Blood glucose increased
13%
C-reactive protein increased
13%
White blood cell count increased
13%
COVID-19
13%
Blood folate decreased
13%
Mitral valve prolapse
13%
Myxomatous mitral valve degeneration
13%
Peripheral swelling
13%
Swelling face
13%
Humerus fracture
13%
Hypokalemia
13%
Presyncope
13%
Acute kidney injury
13%
Vaginal haemorrhage
13%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imsidolimab

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Imsidolimab 400/200 mgExperimental Treatment1 Intervention
Participants received imsidolimab 400 milligrams (mg) by subcutaneous (SC) injection on Day 1, followed by 200 mg on Days 29 and 57.
Group II: Imsidolimab 200/100 mgExperimental Treatment1 Intervention
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
Group III: PlaceboPlacebo Group1 Intervention
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imsidolimab
2019
Completed Phase 2
~340

Find a Location

Who is running the clinical trial?

AnaptysBio, Inc.Lead Sponsor
16 Previous Clinical Trials
1,525 Total Patients Enrolled
Bruce Randazzo, MDStudy DirectorAnaptysBio, Inc.
10 Previous Clinical Trials
696 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Site 10-104
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
2021. "A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04856917.
~31 spots leftby Apr 2025
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