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Monoclonal Antibodies

Imsidolimab for Ichthyosis

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose up to study termination (maximum up to 9.4 weeks)
Awards & highlights

Study Summary

This study is evaluating whether a drug may help improve the appearance of skin in people with a genetic disorder.

Eligible Conditions
  • Ichthyosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose up to study termination (maximum up to 9.4 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose up to study termination (maximum up to 9.4 weeks) 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 Ichthyosis Area Severity Index (IASI) Total Score at Week 16
Secondary outcome measures
Change From Baseline in IASI-E Scores at Week 16
Change From Baseline in IASI-S Scores at Week 16
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
+4 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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ImsidolimabExperimental Treatment1 Intervention
Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
Group II: PlaceboPlacebo Group1 Intervention
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
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
1,643 Total Patients Enrolled
Bruce Randazzo, MDStudy DirectorAnaptysBio, Inc.
10 Previous Clinical Trials
814 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis
2021. "A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04697056.
~1 spots leftby Apr 2025
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