← Back to Search

Monoclonal Antibodies

Spesolimab for Palmoplantar Pustulosis

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Awards & highlights

Study Summary

This trial is for people with palmoplantar pustulosis who have benefited from spesolimab in the past. They will receive monthly injections of the drug to see if it is still effective and safe in the long term.

Eligible Conditions
  • Palmoplantar Pustulosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first administration of study drug until last administration of study drug + 112 days, up to 869 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first administration of study drug until last administration of study drug + 112 days, up to 869 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
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Secondary outcome measures
Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96
Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96
Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96

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

1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 Intervention
Up to 260 weeks
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
2,507 Previous Clinical Trials
11,340,466 Total Patients Enrolled

Frequently Asked Questions

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

What adverse effects may arise from the administration of Spesolimab?

"Our team has assessed the safety of Spesolimab with a score of 2 as this is currently in Phase 2, indicating limited evidence for its efficacy but some data indicative of safety."

Answered by AI

Could you elaborate on any other research projects concerning Spesolimab?

"Currently, there are 5 clinical trials being conducted for Spesolimab. None of these live studies have reached the final phase 3 testing stage yet. These experiments are concentrated in Tunis and Michigan however they span over 329 locations worldwide."

Answered by AI

Is this trial a pioneering effort in its respective field?

"Presently, there are 5 trials for Spesolimab spanning 36 countries and 37 cities. The initial trial was launched in 2018 by Boehringer Ingelheim and comprised 79 patients who were tested during Phase 2 of the drug approval process. Since then, an additional 17 studies have been conducted."

Answered by AI

Is the facility recruiting participants for this clinical investigation at present?

"According to the details on clinicaltrials.gov, this medical trial is no longer actively recruiting for participants; it was published online in September 2020 and last altered in November 2022. Although not currently accepting enrollees, 172 other studies have open recruitment at present time."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
University of Pecs
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
2020. "A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04493424.
~24 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top