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

Phase 2

Completed

Conditions: Hidradenitis Suppurativa

Interventions: Drug: Spesolimab 1200 mg
Drug: Spesolimab 600 mg
Drug: Placebo matching 1200 mg Spesolimab
Drug: Placebo matching 600 mg Spesolimab

Registration Number: NCT04876391

Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 45

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prior Placebo (PP)	Spesolimab 1200 mg	Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Prior Placebo (PP)	Spesolimab 600 mg	Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Prior Placebo (PP)	Placebo matching 600 mg Spesolimab	Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Prior Spesolimab (PS)	Spesolimab 600 mg	Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Prior Spesolimab (PS)	Placebo matching 1200 mg Spesolimab	Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	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).	TEAEs were defined as all adverse events (AEs) occurring from the start of treatment in this extension trial to the end of its residual effect period. AEs that began during the on-treatment period of the parent Proof of Concept and Confirmatory (PoCC) trial (1368-0052) and were still ongoing in this extension trial will also be considered as treatment-emergent.

Secondary Outcome Measures

Name	Time	Method
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	Samples were taken at baseline (Week 0) and at Weeks 2, 4, 6, 8, 10, and 12 after first drug administration.	Percentage of participants with occurrence of at least one flare at Week 12. Flare was defined as at least 25 % increase in abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline. Percentage of participants with occurrence of at least one flare at Week 12 was calculated as: number of participants with occurrence of at least one flare at Week 12/number of participants analyzed \* 100.
Percent Change in Total Abscess and Inflammatory Nodule (AN) Count From Baseline up to Week 12	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.	Percentage change from baseline in total abscess and inflammatory nodule count at Week 12= \[(Total Abscess at Week 12 + Total Inflammatory Nodule at Week 12) - (Total Abscess at baseline + Total Inflammatory Nodule at baseline)\] \*100/ (Total Abscess at baseline + Total Inflammatory Nodule at baseline). Percentage change from baseline in total abscess and inflammatory nodule count at Week 12 was modelled using a restricted maximum likelihood (REML)-based mixed effect model with repeated measures (MMRM) approach, accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, prior use of TNF inhibitor and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12) as well as random effect of each visit. Baseline refers to the last measurement prior to the start of spesolimab. The Least Squares Mean (Standard Error) of percentage change at Week 12 is reported.
Percentage Change in Total Draining Fistula (DF) Count From Baseline up to Week 12	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.	Percentage change from baseline in draining fistula at Week 12 was calculated as: \[(total draining fistula at Week 12) - (total draining fistula at baseline)\] \* 100 %/ (total draining fistula at baseline). Percentage change from baseline in in draining fistula count at Week 12 was modelled using a restricted maximum likelihood (REML)-based mixed effect model with repeated measures (MMRM) approach, accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, prior use of TNF inhibitor and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12) as well as random effect of each visit. Baseline refers to the last measurement prior to the start of spesolimab. Unstructured covariance matrix was used.
Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value up to Week 12	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.	The IHS4 assesses the hidradenitis suppurativa (HS) severity and the resulting IHS4 score is arrived at by= number of nodules \* 1 + number of abscesses \* 2 + number of draining tunnels (fistulae or sinuses) \* 4. A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. The minimum score is 0 while the maximum score is variable and depends on the counts of nodules, abscesses, and draining tunnels (fistulae or sinuses). Absolute change from baseline in IHS4 value at Week 12 was modelled using a restricted maximum likelihood (REML)-based mixed effect model with repeated measures (MMRM) approach, accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, prior use of TNF inhibitor and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12) as well as random effect of each visit. Baseline refers to the last measurement prior to the start of spesolimab.
Percentage of Participants With Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 up to Week 12	At Week 12.	HS-PGA documents the physician's assessment of the participant's HS at a given timepoint. The HS-PGA score ranges from 0 to 5: 0=clear (no abscesses, draining fistula, inflammatory or noninflammatory nodules); 1=minimal (no abscesses, draining fistula, inflammatory nodules; noninflammatory nodules present); 2=mild (no abscesses, draining fistula, 1-4 inflammatory nodules; or 1 abscess or draining tunnel, no inflammatory nodules); 3=moderate (no abscesses, draining fistula, ≥5 inflammatory nodules; or 1 abscess/draining fistula, ≥1 inflammatory nodule; or 2-5 abscesses/draining fistula, \<10 inflammatory nodules); 4=severe (2-5 abscesses/draining fistula, ≥10 inflammatory nodules); 5=very severe (\>5 abscesses/draining fistula). The percentage of participants with HS-PGA 0 or 1 at Week 12 was calculated as: (number with HS-PGA 0/1 at Week 12 ÷ number analyzed) × 100.
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	At baseline (Week 0) and at Week 12.	The analysis assessed the percentage of participants who achieved at least a 30% reduction from baseline in the Numerical Rating Scale (NRS30) for the Participant's Global Assessment of HS Pain by Week 12. The HS Pain Numerical Rating Scale (NRS) measures HS-related pain severity, with a recall period of 24 hours and responses on an 11-point scale from 0 (no pain) to 10 (worst possible pain). For pain analysis, a weekly average of daily assessments was calculated at each visit, based on recorded values before the visit. Weeks with at least four reported daily values were included, ignoring any missing daily values. The percentage of participants achieving at least a 30% reduction from baseline in NRS30 by Week 12 was calculated as the number of participants meeting this criterion divided by the total number of participants analyzed \* 100.
Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) up to Week 12	At baseline (Week 0) and at Week 12.	HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline. Percentage of participants with achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 is reported. Percentage of participants with achievement of HiSCR at Week 12 was calculated as: number of participants with achievement of HiSCR at Week 12/number of participants analyzed \* 100.
Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score up to Week 12	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.	The HASI assesses HS severity across four domains: erythema, induration, open ulcer, and draining fistula, scored on a 0 (none) to 3 (severe/extensive) Likert scale for each body region. For body surface area (BSA) assessment, the number of palms (one palm indicates 1% of the participant's BSA) involved for each body region (head, right axilla, left axilla, anterior chest, back, anterior bathing trunk, posterior bathing trunk, other) is assessed and converted to a percentage of that region. An area score was assigned to each region using the approach (0 = none, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, 6 = 90- 100%). Scores for the four domains of HS are summed and adjusted for the area affected, and the score of each area are summed to calculate the total HASI score, which ranges from 0 (no disease) to 72 (severe disease). The Least Squares Mean (Standard Error (SE)) was derived from mixed effect model with repeated measures (MMRM).

Trial Locations

Locations (21): Dawes Fretzin Clinical Research Group, LLC-Indianapolis-58713
🇺🇸
Indianapolis, Indiana, United States
Erasmus Medisch Centrum-ROTTERDAM-50697
🇳🇱
Rotterdam, Netherlands
Dermatology Research Associates
🇺🇸
Los Angeles, California, United States
Mayo Clinic, Rochester
🇺🇸
Rochester, Minnesota, United States
Unity Clinical Research
🇺🇸
Oklahoma City, Oklahoma, United States
Holdsworth House Medical Practice
🇦🇺
Sydney, New South Wales, Australia
Royal Melbourne Hospital
🇦🇺
Parkville, Victoria, Australia
Dr. S. K. Siddha Medicine Professional Corporation
🇨🇦
Newmarket, Ontario, Canada
University Hospital Ostrava
🇨🇿
Ostrava, Czechia
CLI Reims Bezannes
🇫🇷
Bezannes, France
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Dawes Fretzin Clinical Research Group, LLC-Indianapolis-58713
🇺🇸Indianapolis, Indiana, United States