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Spesolimab for Pustular Psoriasis

Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a known and documented history of GPP per ERASPEN criteria (see Section 3.3.1) regardless of IL36RN mutation status, with at least 2 presentations of moderate to severe GPP flares with fresh pustulation (new appearance or worsening) in the past.
Patients with a GPPGA score of 0 or 1 at screening and randomization.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pss assessments were performed at: baseline (week 1) and up to week 48 (at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48). visit window was ±7 days.
Awards & highlights

Study Summary

This trial is testing spesolimab to see if it can help prevent GPP flare-ups in adolescents and adults.

Eligible Conditions
  • Pustular Psoriasis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pss assessments were performed at: baseline (week 1) and up to week 48 (at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48). visit window was ±7 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and pss assessments were performed at: baseline (week 1) and up to week 48 (at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48). visit window was ±7 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to First Generalized Pustular Psoriasis (GPP) Flare
Secondary outcome measures
Key Secondary Endpoint: The Occurrence of at Least One Generalized Pustular Psoriasis (GPP) Flare up to Week 48
Sustained Remission
The Occurrence of Treatment Emergent Adverse Events (TEAEs)
+2 more

Side effects data

From 2020 Phase 2 & 3 trial • 98 Patients • NCT03482635
8%
Syncope
8%
Colitis ulcerative
8%
Nasopharyngitis
4%
Anaemia
4%
Rash
4%
Infusion related reaction
4%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
300 mg Spesolimab (BI 655130) SD
1200 mg Spesolimab (BI 655130) q4w
450 mg Spesolimab (BI 655130) q4w

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Spesolimab SC medium doseExperimental Treatment1 Intervention
Group II: Spesolimab SC low doseExperimental Treatment1 Intervention
Group III: Spesolimab SC high doseExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spesolimab
2016
Completed Phase 3
~580

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,494 Previous Clinical Trials
10,916,749 Total Patients Enrolled

Frequently Asked Questions

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

Will this research be testing individuals who are octogenarians?

"This study allows for a wide age range of participants, with the minimum being 12 years old and the maximum being 75."

Answered by AI

Would I be able to help out with this research project?

"In order to qualify for this clinical trial, potential participants must have a diagnosis of gpp and be between 12-75 years old. There is a total need for 123 individuals in the study."

Answered by AI

Are there other drugs that have been studied in combination with Spesolimab?

"To date, there are 5 ongoing clinical trials for Spesolimab with none of them in Phase 3. The highest concentration of research is in Mainz and California; however, you can find 329 different locations running clinical trials related to Spesolimab."

Answered by AI

When might Spesolimab be available for public use?

"Spesolimab's safety is based on early data from Phase 2 trials, which only provides limited evidence supporting its usage."

Answered by AI

Does this medical research break new ground?

"Spesolimab is being trialed in 37 cities, across 36 countries and there are 5 active trials. The first trial was conducted in 2018 by 79 participants. The sponsor of the study, Boehringer Ingelheim completed its Phase 2 drug approval stage. In total, 18298 have been completed since then."

Answered by AI

Are we still receiving volunteers for this experiment?

"Unfortunately, this study is not currently looking for participants. Although the details on clinicaltrials.gov show that it was most recently updated on November 15th, 2022, recruitment for this trial has already concluded. However, there are plenty of other opportunities to get involved in medical research; as of right now, there are 184 other trials enrolling patients."

Answered by AI

How many participants are being sought for this research?

"As of now, this clinical trial is not admitting any more patients. This experiment was first posted on June 4th 2020 and was updated on November 15th 2020. If you are looking for other similar studies, there are 179 clinical trials actively recruiting participants who have generalized pustular psoriasis (gpp) and 5 studies for Spesolimab that still need volunteers."

Answered by AI
~26 spots leftby Mar 2025