← Back to Search

Spesolimab for Hidradenitis Suppurativa

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 week 12
Awards & highlights

Summary

This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa. Participants are put into 2 groups by chance. One group takes spesolimab. The other group takes placebo. Every participant has twice the chance of being in the spesolimab group than in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and injections but do not contain any medicine. Participants are treated in the study for about 3 months. During this time, they visit the study site about 9 times. After completing this part of the study, participants are offered to join another clinical study in which all participants get spesolimab. Participants who cannot join the other study, stay in this study for about 4 more months. During this time, participants do not take spesolimab nor placebo but they visit the study site 2 times to have their health checked. At study visits, doctors thoroughly check the skin of participants to count lumps (nodules) and boils (abscesses). The results between the spesolimab group and the placebo group are compared after 3 months of treatment. The doctors also regularly check the general health of the participants.

Eligible Conditions
  • Hidradenitis Suppurativa

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at week 12
Hidradenitis
Absolute change from baseline in Hidradenitis Suppurativa Quality of Life (HiS-QoL) Total score at week 12
+4 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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SpesolimabExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spesolimab
2016
Completed Phase 3
~700

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,534 Previous Clinical Trials
11,357,475 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
795 Patients Enrolled for Hidradenitis Suppurativa
~12 spots leftby Sep 2025