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Monoclonal Antibodies

Spesolimab for Hidradenitis Suppurativa

Phase 2 & 3
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration
Be older than 18 years old
Must not have
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Use of immunomodulatory biologics or investigational agents since the last visit of the parent trials
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is for people with hidradenitis suppurativa who have previously participated in a study with spesolimab. The purpose of this trial is to see how well people tolerate sp

Who is the study for?
This trial is for people with a skin condition called Hidradenitis Suppurativa (HS) who finished a previous spesolimab study without dropping out early. They must be within 16 weeks of their last spesolimab dose and women able to have children need to use effective birth control.
What is being tested?
The trial tests long-term tolerance and effectiveness of Spesolimab in HS patients. Participants receive Spesolimab injections every two weeks for about 1.5 years, with the total study duration being around 2 years including both in-person and video call visits.
What are the potential side effects?
Potential side effects from Spesolimab are not specified here, but generally could include reactions at the injection site, flu-like symptoms, headache, or other immune-related effects as seen with similar medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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It has been less than 16 weeks since my last spesolimab treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, nursing, nor planning to become pregnant during the trial.
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I haven't used any immune-boosting drugs or experimental treatments since my last trial visit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Patients treated in parent trial 1368-0100Experimental Treatment1 Intervention
Group II: Patients treated in Part II of parent trial 1368-0098 (NCT05819398)Experimental Treatment1 Intervention
Group III: Patients treated in Part I of parent trial 1368-0098 (NCT05819398)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
2,549 Previous Clinical Trials
14,400,766 Total Patients Enrolled
~367 spots leftby Apr 2030
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