Gemini Trial

  • STATUS
    Recruiting
  • sponsor
    Anaptys Bio
Updated on 10 March 2022

Summary

We are currently recruiting patients with Generalized Pustular Psoriasis (GPP) for a study that investigates the effectiveness and safety of the drug imsidolimab.

Description

This study will last for a period of up to 21 months. An 18-month screening period is planned for evaluating patients that are not currently experiencing flares of GPP, and will be re-evaluated every 6 months, or upon experiencing a flare. Once the patient is in flare, he or she may begin the screening period (Part 2) to continue the journey towards the study treatment day. During the treatment period, there are 8 visits over a 3-month period. Visits take approximately 1 to 3 hours each, except for the screening visit of part 2 that may take up to 4 hours. 

Several blood samples will be collected on Day 1, Day 3, Week 1, Week 2, Week 4, Week 8 and Week 12. During the study visits, a physical evaluation of your GPP and overall health will be done by the study team. Non-invasive tape stripping to collect surface skin tissue samples will also be performed, and photography of your lesions will be conducted.

You may be offered to take part in another optional aspect of the trial, which includes additional blood draws and skin biopsies of your GPP lesions. For the biopsy portion, there will be a total of three punch biopsies.

At the end of the study, participants may be eligible to participate in the subsequent long term extension study, which may allow participants to receive the study treatment as a monthly injection under the skin, regardless of what they received during the first study. More information will be made available to you should you be interested.

For more information and to register to the study, please visit the study page:
https://gpptrial.com/

Details
Condition Psoriasis and Psoriatic Disorders
Clinical Study IdentifierTX291197
SponsorAnaptys Bio
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

You are between 18 and 80 years old inclusively
You've had Generalized Pustular Psoriasis with active lesions or had active lesions in the past of Generalized Pustular Psoriasis?
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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