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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 252 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment
Secondary outcome measures
A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit
Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit
The reoccurrence of a GPP flare defined by GPPGA
+1 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

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
~580

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,340,161 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

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~54 spots leftby Sep 2027