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A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04762277
Recruitment Status : Completed
First Posted : February 21, 2021
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.


Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: Spesolimab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled, Study of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa
Actual Study Start Date : April 6, 2021
Actual Primary Completion Date : January 19, 2022
Actual Study Completion Date : April 21, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spesolimab Drug: Spesolimab
Spesolimab

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Percent change from baseline in total abscess and inflammatory nodule count (AN) at week 12 [ Time Frame: baseline, week 12 ]

Secondary Outcome Measures :
  1. Percent change from baseline in draining fistula count at week 12 [ Time Frame: baseline, week 12 ]
  2. Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12 [ Time Frame: week 12 ]
    HiSCR is defined as at least a 50% reduction in the total AN count with no increase in abscess count and no increase in draining fistula count relative to baseline.

  3. Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value at week 12 [ Time Frame: baseline, 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.

  4. Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score at week 12 [ Time Frame: baseline, 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).

  5. Achievement of Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1 at week 12 [ Time Frame: 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. Achievement of at least 30% reduction from baseline in Numerical rating scale (NRS30) in Patient's Global Assessment of Hidradenitis suppurativa (HS) Pain at week 12 [ Time Frame: baseline, week 12 ]
    The Pain NRS assesses the HS-related pain severity. The Pain NRS will be completed on a daily diary by subjects from Screening through Week 12. Response is given by an 11-point scale ranging from 0 (no HS pain) to 10 (HS pain as bad as one can imagine).

  7. Occurrence of complete elimination of draining fistulas at Week 12 [ Time Frame: week 12 ]
  8. 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 [ Time Frame: up to week 12 ]
  9. Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at week 12 [ Time Frame: baseline, week 12 ]
    DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. It's total score is calculated by summing the scores of each question resulting in a range of 0 to 30. The higher the score, the more the quality of life is impaired.

  10. Absolute change from baseline in Hidradenitis Suppurativa Quality of Life (HiS-QoL) Total score at week 12 [ Time Frame: baseline, week 12 ]
    HiS-QoL is a patient-administered, 17-item instrument to measure HS-specific quality of life in clinical trials. The 17-item HiS-QoL included four symptom items, eight activity-adaptation items and five psychosocial items. The item scores are summed to create a total ranging from 0 to 68, with higher scores indicating more severe impact on quality of life.

  11. The occurrence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: up to week 16 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female adult patients, 18 years of age or older
  • Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedures
  • Moderate to severe Hidradenitis suppurativa (HS), based on International Hidradenitis Suppurativa Severity Score System (IHS4) criteria, for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history. (If IHS4 scoring is not available, equivalent scoring based on scoring systems as HS-PGA or Hurley are acceptable based on documented investigator assessment)
  • HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, perineal)
  • Biologic naive or TNF inhibitor (TNFi)-failure for HS
  • Inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS in the last 1 year, as per investigator discretion. This is not applicable for TNFi-failure patients
  • Total abscess and inflammatory nodule (AN) count of greater than or equal to 5
  • Total draining fistula count of less than or equal to 20 Further inclusion criteria apply

Exclusion Criteria:

  • Presence of active skin lesions other than HS that interfere with the assessment of HS
  • Use of restricted medications as below:

    • Topical corticosteroids over HS lesions within 1 week of Visit 2
    • Systemic antibiotics within 4 weeks of visit 2
    • Systemic non-biologic immunomodulatory and/or immunosuppressive agents use for HS within 4 weeks (or 5 half lives, whichever is longer) of visit 2
    • Biologic agents use within 12 weeks or 5 half-lives, whichever is longer, prior to visit 2
    • Opioid analgesics within 2 weeks of visit 2
    • Live virus vaccine within 6 weeks of visit 2
  • Prior exposure to any immunosuppressive biologic other than TNFi for HS
  • Prior exposure to Interleukin 36 Receptor (IL-36R) inhibitors including spesolimab
  • Treatment with any investigational device or investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to visit 2
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating
  • History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients
  • Patient with a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening) or who have ever received stem cell therapy (e.g., Remestemcel-L) Further exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04762277


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04762277    
Other Study ID Numbers: 1368-0052
2020-003672-40 ( EudraCT Number )
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration