Clinical trial NCT04876391: A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
Official title: An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-05-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment).
Secondary outcomes:
measure: Percent Change in Total Abscess and Inflammatory Nodule (AN) Count From Baseline up to Week 12
timeFrame: MMRM included measurements from baseline (Week 12 of 1368-0052) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration.
measure: Percentage Change in Total Draining Fistula (DF) Count From Baseline up to Week 12
timeFrame: MMRM included measurements from baseline (Week 12 of 1368-0052) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percentage change in draining fistula from baseline to Week 12 is reported.
measure: Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) up to Week 12
timeFrame: At baseline (Week 0) and at Week 12.
measure: Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value up to Week 12
timeFrame: MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change in IHS4 from baseline to Week 12 is reported.
measure: Percentage of Participants With Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 up to Week 12
timeFrame: At Week 12.
measure: Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score up to Week 12
timeFrame: MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change from baseline in HASI score at Week 12 is reported.
measure: Patients With 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
timeFrame: Samples were taken at baseline (Week 0) and at Weeks 2, 4, 6, 8, 10, and 12 after first drug administration.
measure: 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
timeFrame: At baseline (Week 0) and at Week 12.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC-Indianapolis-58713
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic, Rochester
state: Minnesota
city: Oklahoma City
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Newmarket
country: Canada
facility: Dr. S. K. Siddha Medicine Professional Corporation
state: Ontario
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Bezannes
country: France
facility: CLI Reims Bezannes
city: Lyon
country: France
facility: HOP Edouard Herriot
city: Toulouse
country: France
facility: HOP Larrey
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum gGmbH
city: Dessau
country: Germany
facility: Städtisches Klinikum Dessau
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Ancona
country: Italy
facility: Ospedali Riuniti di Ancona
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum-ROTTERDAM-50697
city: Bodø
country: Norway
facility: Nordlandssykehuset HF, Bodø
city: Ossy
country: Poland
facility: Non-Public Health Care Facility LABDERM
city: Wroclaw
country: Poland
facility: Cityclinic Medical and Psychological Clinic Matusiak Partnership
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
Study officials:
References: