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Monoclonal Antibodies

Long-term Spesolimab Treatment 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 up to week 120

Awards & highlights

Study Summary

This trial is for adults with hidradenitis suppurativa who have completed a previous clinical study of spesolimab. It is designed to see if the drug is safe and effective in the long term. Injections are given every two weeks for two years.

Who is the study for?

Adults with hidradenitis suppurativa who were in a prior spesolimab study can join. They must have finished the previous trial without early stoppage, agree to birth control if applicable, and not be planning pregnancy or major surgery. Those with severe health issues or allergies to the drug are excluded.Check my eligibility

What is being tested?

The trial tests long-term safety and effectiveness of spesolimab for hidradenitis suppurativa over approximately 2 years and 4 months. Participants receive bi-weekly injections and undergo regular health checks to monitor their skin condition's severity.See study design

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any health problems that may arise from receiving spesolimab injections regularly over an extended period.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 120

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 120

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 120 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) up to the end of maintenance treatment period including residual effect period (REP)

Secondary outcome measures

Hidradenitis

Achievement of at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of HS Pain up to week 12

Hidradenitis

+5 more

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

1Treatment groups

Experimental Treatment

Group I: Participants from parent trial (1368-0052) who were on placebo or active medicationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spesolimab

2016

Completed Phase 3

~580

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,505 Previous Clinical Trials

11,340,247 Total Patients Enrolled

3 Trials studying Hidradenitis Suppurativa

802 Patients Enrolled for Hidradenitis Suppurativa

Media Library

Spesolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04876391 — Phase 2

Hidradenitis Suppurativa Research Study Groups: Participants from parent trial (1368-0052) who were on placebo or active medication

Hidradenitis Suppurativa Clinical Trial 2023: Spesolimab Highlights & Side Effects. Trial Name: NCT04876391 — Phase 2

Spesolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04876391 — Phase 2

Frequently Asked Questions

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

Has Spesolimab been granted authorization by the FDA?

"Judged on a 1 to 3 scale, Spesolimab's safety is estimated to be 2. This evaluation results from the Phase 2 trial status of this medication, which has provided some evidence for its security but not efficacy yet."

Answered by AI

What prior investigations have occurred related to Spesolimab?

"The initial studies of spesolimab began in 2018 at Tokyo Medical and Dental University. To date, 17 experiments have been completed with 5 more being recruited for in locations such as Los Angeles, California."

Answered by AI

How many participants are currently receiving treatment as part of this research?

"This clinical trial is no longer taking new patients. Initially posted on July 27th 2021, the study's last update occurred November 14th 2022. If you are seeking trials for other conditions, there are 37 studies recruiting individuals with hidradenitis suppurativa and five researching Spesolimab that have open recruitment slots."

Answered by AI

Is this an unprecedented exploration of the subject?

"Currently, there are 5 ongoing Spesolimab trials spanning 36 countries and 37 cities. This drug was initially tested in a Phase 2 study sponsored by Boehringer Ingelheim back in 2018 with 79 participants. Since then, 17 more clinical studies have been conducted."

Answered by AI

Are there any available slots in this research initiative for participants?

"This investigation is no longer enrolling new participants. Initially posted on July 27th 2021 with the last edit occurring November 14th 2022, this study has now been concluded. Although, there are currently 37 studies open to patients suffering from hidradenitis suppurativa and 5 tests that involve Spesolimab recruiting volunteers."

Answered by AI

How many locations is this clinical research overseen in?

"As part of this medical trial, enrolment is open at Dermatology Research Associates in Los Angeles, Dawes Fretzin Clinical Research Group LLC in Indianapolis and Mayo Clinic Rochester in Minnesota. Additionally, 4 other clinical sites are welcoming participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial

2021. "A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04876391.

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