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Monoclonal Antibodies

Patients treated in parent trial 1368-0100 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 92 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

It has been less than 16 weeks since my last spesolimab treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 92 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 92 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 92 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 (TEAE)

Side effects data

From 2020 Phase 2 & 3 trial • 98 Patients • NCT03482635

Syncope

Colitis ulcerative

Nasopharyngitis

Anaemia

Rash

Infusion related reaction

Arthralgia

100%

80%

60%

40%

20%

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: 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

~620

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,510 Previous Clinical Trials

11,340,508 Total Patients Enrolled

3 Trials studying Hidradenitis Suppurativa

297 Patients Enrolled for Hidradenitis Suppurativa

Frequently Asked Questions

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

Are there any available slots for patients to participate in this research study?

"As documented on clinicaltrials.gov, this research endeavor is actively pursuing potential participants. The trial's initial posting was made on April 16th, 2024, with the latest revision occurring on April 22nd of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab

2024. "A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06241573.

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