Your session is about to expire
← Back to Search
Monoclonal Antibodies
Imsidolimab low dose for Pustular Psoriasis (GEMINI1 Trial)
Phase 3
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights
Summary
This trial is testing a new medication called imsidolimab to help adults with a severe skin condition known as generalized pustular psoriasis. The medication aims to reduce inflammation and skin pustules by calming the immune system. Researchers are also studying how the body processes the medication and its potential side effects.
Eligible Conditions
- Generalized Pustular Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of subjects achieving Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) score of 0 (clear) or 1 (almost clear)
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: IV low dose Imsidolimab, other name ANB019Experimental Treatment1 Intervention
ANB019 Biological Humanized Monoclonal Antibody Low Dose
Group II: IV high dose Imsidolimab, other name ANB019Experimental Treatment1 Intervention
ANB019 Biological Humanized Monoclonal Antibody High Dose
Group III: IV PlaceboPlacebo Group1 Intervention
Placebo Solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imsidolimab
Not yet FDA approved
Imsidolimab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
AnaptysBio, Inc.Lead Sponsor
16 Previous Clinical Trials
1,603 Total Patients Enrolled
Bruce Randazzo, MDStudy DirectorAnaptysBio, Inc.
10 Previous Clinical Trials
774 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a type of psoriasis that is different from psoriasis vulgaris.Your condition is so severe that your life is in danger.You have pustules (excluding palms and soles) ≥ 5%, a GPPPGA score ≥ 3 (moderate severity), and a PRS score ≥ 3 (moderate severity) at Day 1.
Research Study Groups:
This trial has the following groups:- Group 1: IV Placebo
- Group 2: IV high dose Imsidolimab, other name ANB019
- Group 3: IV low dose Imsidolimab, other name ANB019
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger