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Spesolimab for Pustular Psoriasis
Study Summary
This trial will test the safety and efficacy of spesolimab in patients who have completed previous trials and qualify for this one.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 & 3 trial • 98 Patients • NCT03482635Trial Design
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Who is running the clinical trial?
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- I haven't taken any medication that could affect this study, except for certain allowed drugs after a specific treatment.My liver tests are not severely abnormal.I have no active cancers except for certain skin cancers or cervical cancer that's been treated.I have completed treatment for tuberculosis if my test was positive.I do not have active tuberculosis.I am allergic to certain medications or their ingredients.I have been diagnosed with congestive heart failure.I completed a previous spesolimab trial without stopping early and am willing to continue treatment.I do not have ongoing infections like HIV or hepatitis, or I have been treated and cured from such an infection.I can be retested for TB if my initial tests were unclear.I am experiencing moderate to severe flare symptoms currently.I have been tested for TB and either completed treatment if positive or tested negative.
- Group 1: Spesolimab (every 4 weeks)
- Group 2: Spesolimab (every 6 weeks)
- Group 3: Spesolimab (every 12 weeks)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is this experiment accepting geriatric participants?
"The age range of the participants accepted into this trial is between 12 and 75. For those younger than twelve, there are 33 trials available while 147 exist for seniors exceeding 65 years old."
Do I meet the criteria necessary to participate in this experiment?
"This clinical trial is looking for 155 individuals with generalized pustular psoriasis (GPP) between 12 and 75 years of age. They must have completed the prior spesolimab treatment period without discontinuation, be willing to take part in this current study, use highly effective methods of contraception as outlined in Section 4.2.2.3 of the patient information document, provide signed written informed consent/assent per ICH-GCP guidelines, and meet other criteria listed therein."
Is this investigation pioneering in its design?
"Currently, 5 trials of Spesolimab are in progress across 36 countries and 37 cities. This clinical evaluation began back in 2018 when Boehringer Ingelheim sponsored a Phase 2 study that involved 79 participants. Since then, 17 more studies have been concluded."
What precedent studies have there been regarding Spesolimab?
"Currently, Spesolimab is being trialled in 5 active studies with none at phase 3. These trials are taking place across 329 medical centres mainly located in Mainz and California."
What safety considerations should be taken into account when administering Spesolimab to patients?
"The safety rating of spesolimab is assessed to be 2, as there are some initial indications that it can provide protection against harm, but not yet any evidence for effectiveness."
Are enrollment slots still available in this investigation?
"According to the clinicaltrials.gov database, this clinical trial is recruiting participants; it was first published on May 27th 2019 and has been recently updated on November 28th 2022."
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