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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04876391
Collaborator
(none)
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Study Details

Study Description

Brief Summary

This study is open to adults with hidradenitis suppurativa who took part in a previous clinical study of a medicine called spesolimab. Participants who completed treatment can join this study.

The purpose of this study is to find out how safe spesolimab is and whether it helps people with hidradenitis suppurativa in the long-term. Participants are in this study for about 2 years and 4 months. For 2 years, participants visit the study site every 2 weeks to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' hidradenitis suppurativa and collect information on any health problems of the participants.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
All medication kit assignments will occur in an open label fashion except for medications provided for visit 1. Only administration of study medication at visit 1 is blinded.
Primary Purpose:
Treatment
Official Title:
An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)
Actual Study Start Date :
Jul 27, 2021
Anticipated Primary Completion Date :
Apr 29, 2024
Anticipated Study Completion Date :
May 23, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participants from parent trial (1368-0052) who were on placebo or active medication

Drug: Spesolimab
Spesolimab

Outcome Measures

Primary Outcome Measures

  1. Occurrence of treatment emergent adverse events (TEAE) up to the end of maintenance treatment period including residual effect period (REP) [up to week 120]

Secondary Outcome Measures

  1. Percentage change in total abscess and inflammatory nodule (AN) count from baseline up to week 12 [up to week 12]

  2. Percentage change in total draining fistula (DF) count from baseline up to week 12 [up to week 12]

  3. Hidradenitis Suppurativa Clinical Response (HiSCR) [up to week 12]

    HiSCR is defined as at least a 50% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase in the abscess or draining fistula count.

  4. Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value up to week 12 [up to week 12]

    The IHS4 assesses the HS severity and the resulting IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease.

  5. Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1 [up to week 12]

    The HS-PGA score ranges from 0 to 5, where 0 (clear, no abscesses, draining tunnels, inflammatory nodules or noninflammatory nodules), 1 (minimal, no abscesses, draining tunnels or inflammatory nodules and the presence of noninflammatory nodules), 2 (mild, no abscesses or draining tunnels and 1-4 inflammatory nodules, or 1 abscess or draining tunnel and no inflammatory nodules), 3 (moderate, no abscesses or draining tunnels and ≥5 inflammatory nodules, or 1 abscess or draining tunnel and ≥1 inflammatory nodule, or 2-5 abscesses or draining tunnels and <10 inflammatory nodules), 4 (severe, 2-5 abscesses or draining tunnels and ≥10 inflammatory nodules), 5 (very severe, >5 abscesses or draining tunnels).

  6. Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score up to week 12 [up to week 12]

    HASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (severe disease).

  7. Occurrence of at least one flare (defined as at least 25 % increase in AN count with a minimum increase of 2 relative to baseline) up to week 12 [up to week 12]

  8. 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 [up to week 12]

    The Pain NRS assesses the HS-related pain severity. The Pain NRS is completed by the patients during clinic visits. Response is given by an 11-point scale ranging from 0 (no HS pain) to 10 (HS pain as bad as one can imagine).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who have completed treatment in the parent Hidradenitis suppurativa (HS) spesolimab trial (1368-0052) without premature discontinuation

  • Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

  • Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and consent form.

Exclusion Criteria:
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial

  • Patients who experienced study treatment-limiting adverse events during the 1368-0052 parent trial

  • Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof

  • Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix

  • Use of any restricted medication or any drug considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the 1368-0052 parent trial

  • History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients

  • Major surgery (major according to the investigator's assessment) planned during this extension trial (e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator

  • Any condition which in the opinion of the investigator affects the safety of the patient, the patient's ability to participate in this trial or could compromise the quality of data Further exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dermatology Research Associates Los Angeles California United States 90045
2 Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana United States 46250
3 Mayo Clinic, Rochester Rochester Minnesota United States 55905
4 Unity Clinical Research Oklahoma City Oklahoma United States 73118
5 Holdsworth House Medical Practice Sydney New South Wales Australia 2010
6 Royal Melbourne Hospital Parkville Victoria Australia 3050
7 Dr. S. K. Siddha Medicine Professional Corporation Newmarket Ontario Canada L3Y 5G8
8 University Hospital Ostrava Ostrava Czechia 708 52
9 CLI Reims Bezannes Bezannes France 51430
10 HOP Edouard Herriot Lyon France 69437
11 HOP Larrey Toulouse France 31059
12 Katholisches Klinikum Bochum gGmbH Bochum Germany 44791
13 Städtisches Klinikum Dessau Dessau Germany 06847
14 Universitätsklinikum Frankfurt Frankfurt am Main Germany 60596
15 Ospedali Riuniti di Ancona Ancona Italy 60123
16 Azienda Ospedaliera Universitaria Pisana Pisa Italy 56126
17 Erasmus Medisch Centrum Rotterdam Netherlands 3015 GD
18 Nordlandssykehuset HF, Bodø Bodø Norway N-8092
19 Non-Public Health Care Facility LABDERM Ossy Poland 42624
20 Cityclinic Medical and Psychological Clinic Matusiak Partnership Wroclaw Poland 50-566
21 Hospital Santa Creu i Sant Pau Barcelona Spain 08026

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04876391
Other Study ID Numbers:
  • 1368-0067
  • 2020-005587-55
First Posted:
May 6, 2021
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022