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Monoclonal Antibodies

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
Must not have
Severe, progressive, or uncontrolled hepatic disease, defined as >3- fold Upper Limit of Normal (ULN) elevation in Aspartate Transaminase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or >2- fold ULN elevation in total bilirubin
Any documented active or suspected malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 252 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the safety and efficacy of spesolimab in patients who have completed previous trials and qualify for this one.

Who is the study for?
This trial is for men and women who previously participated in a spesolimab study without early dropout. They must consent to continue treatment, use effective birth control if of childbearing potential, and not have moderate/severe psoriasis flare symptoms or certain infections like HIV or tuberculosis.
What is being tested?
The trial tests the long-term safety and effectiveness of Spesolimab in patients with Generalized Pustular Psoriasis (GPP) who completed prior Spesolimab trials. It aims to understand how well the drug works over an extended period.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to long-term Spesolimab use, which could include issues related to immune response, infection risks, liver function changes, or other drug-related complications.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver tests are not severely abnormal.
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I have no active cancers except for certain skin cancers or cervical cancer that's been treated.
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I do not have active tuberculosis.
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I am allergic to certain medications or their ingredients.
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I am experiencing moderate to severe flare symptoms currently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 252 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 252 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit
The reoccurrence of a GPP flare defined by GPPGA

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Spesolimab (every 6 weeks)Experimental Treatment1 Intervention
Group II: Spesolimab (every 4 weeks)Experimental Treatment1 Intervention
Group III: Spesolimab (every 12 weeks)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spesolimab
2016
Completed Phase 3
~650

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,551 Previous Clinical Trials
15,857,893 Total Patients Enrolled

Media Library

Spesolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03886246 — Phase 2
Pustular Psoriasis Research Study Groups: Spesolimab (every 4 weeks), Spesolimab (every 6 weeks), Spesolimab (every 12 weeks)
Pustular Psoriasis Clinical Trial 2023: Spesolimab Highlights & Side Effects. Trial Name: NCT03886246 — Phase 2
Spesolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03886246 — Phase 2
~44 spots leftby Sep 2027
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