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Monoclonal Antibodies

Imsidolimab for Generalized Pustular Psoriasis (GEMINI2 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
Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
Pivotal Trial

GEMINI2 Trial Summary

This trial is testing a new drug for people with a certain type of psoriasis. The goal is to see if it is safe and effective.

Who is the study for?
This trial is for adults with generalized pustular psoriasis who completed at least the first week of a previous Phase 3 study without using any rescue or prohibited medications. Candidates must be deemed in need of long-term treatment by the investigator.Check my eligibility
What is being tested?
The trial is testing the long-term safety and effectiveness of Imsidolimab, an investigational drug, against a placebo in managing symptoms and flare-ups associated with generalized pustular psoriasis.See study design
What are the potential side effects?
While specific side effects are not listed here, common side effects for drugs treating psoriasis may include skin irritation, headaches, fatigue, nausea, and potential immune system changes.

GEMINI2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My doctor thinks long-term GPP treatment is right for me.

GEMINI2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

GEMINI2 Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: SC ImsidolimabActive Control1 Intervention
Subcutaneous Imsidolimab
Group II: IV +SC ImsidolimabActive Control1 Intervention
IV loading dose followed by subcutaneous Imsidolimab
Group III: Standard of CareActive Control1 Intervention
Any available therapy
Group IV: SC PlaceboPlacebo Group1 Intervention
Subcutaneous Placebo

Find a Location

Who is running the clinical trial?

AnaptysBio, Inc.Lead Sponsor
16 Previous Clinical Trials
1,606 Total Patients Enrolled
Bruce Randazzo, MDStudy DirectorAnaptysBio, Inc.
10 Previous Clinical Trials
777 Total Patients Enrolled

Media Library

Imsidolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05366855 — Phase 3
Pustular Psoriasis Research Study Groups: SC Imsidolimab, IV +SC Imsidolimab, SC Placebo, Standard of Care
Pustular Psoriasis Clinical Trial 2023: Imsidolimab Highlights & Side Effects. Trial Name: NCT05366855 — Phase 3
Imsidolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05366855 — Phase 3
Pustular Psoriasis Patient Testimony for trial: Trial Name: NCT05366855 — Phase 3

Frequently Asked Questions

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

What is the largest amount of people that can be in this trial?

"That is correct, the online clinicaltrial database lists this trial as recruiting. This particular trial was first posted on 4/21/2022 and was last updated on 9/12/2022. Currently, the study is looking for 45 individuals willing to participate at 6 different locations."

Answered by AI

Where are the sites for this trial?

"There are a total of six locations where this trial is currently taking place. They are situated in Largo, Ann Arbor, Dallas and other, as yet unnamed, cities. It would be beneficial for you to choose the location closest to you to cut down on travel if you decide to take part in the trial."

Answered by AI

What are the requirements for joining this clinical trial?

"Up to 45 individuals aged 18 to 80 that have been diagnosed with generalized pustular psoriasis (gpp) are eligible for this clinical trial. Key inclusion criteria include: the patient must have participated in the preceding placebo-controlled Phase 3 study ANB019-301 and completed the Week 1 visit without needing rescue/prohibited medication for GPP, and the patient must be a candidate for prolonged GPP treatment according to the Investigator's judgment."

Answered by AI

If a patient is over 35, are they still eligible for this program?

"This specific trial requires that patients be aged between 18-80, which is a more restrictive age range than the average trial (32 for those under 18 and 154 for those over 65)."

Answered by AI

Does SC Imsidolimab have any known negative effects on patients?

"SC Imsidolimab has undergone multiple clinical trials with supportive data, meaning it is a safe medication with a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Utah
What site did they apply to?
Site 102
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

how much does it pay?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

despite my condition , i need money.
PatientReceived 1 prior treatment
~5 spots leftby Jun 2024