Hidradenitis SuppurativaEARLY-HS 2NCT07690319
A Study of Early Secukinumab Treatment in Moderate to Severe Hidradenitis Suppurativa Patients
An observational study of Hidradenitis Suppurativa, run by Novartis Pharmaceuticals.
Trial summary
The aim of this study is to evaluate the effectiveness of early treatment with secukinumab in patients with moderate-to-severe hidradenitis suppurativa (HS) and assess its impact on disease progression using data from multiple European data sources. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- 13 Nov 2026to 15 Mar 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with moderate-to-severe HS who initiated secukinumab treatment.
Who may be able to join
- Patients with a documented diagnosis of HS (e.g., International Classification of Diseases, 10th Revision [ICD-10] code L73.2);
- Age ≥18 years at index date;
- Moderate-to-severe HS as per label;
- Initiation of secukinumab treatment on or after the first HS diagnosis date;
- And at least one follow-up assessment at 6 or 12 months after index date.
Who cannot join
- Patients who had major HS-related surgery (Skin-tissue-sparing Excision with Electrosurgical Peeling [STEEP] or wide excision) in the 12 months prior to index date;
- Patients participating in interventional clinical trials at index date.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: Early Secukinumab Treatment in Moderate to Severe Hidradenitis Suppurativa Patients: Early Action Reduces Long-term Yield in Hidradenitis Suppurativa (EARLY HS 2)
The aim of this study is to evaluate the effectiveness of early treatment with secukinumab in patients with moderate-to-severe hidradenitis suppurativa (HS) and assess its impact on disease progression using data from multiple European data sources. All data will be sourced from existing non-interventional study primary data collection, registries, and hospital cohorts that captured information collected in routine clinical practice, prior to and independent of this study.
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, Secukinumab, Early treatment, Real-world evidence
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early Treatment Group | Adult patients with moderate to severe HS, having up to 1 active tunnel (draining or non-draining) or up to 4 inflammatory lesions (abscess/nodules) at date of first secukinumab administration for HS treatment. | |
| Late Treatment Group | Adult patients with moderate to severe HS, having >1 active tunnel or >4 inflammatory lesions, at date of first secukinumab administration for HS treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Achieving 55% Reduction From Baseline in International Hidradenitis Suppurativa Severity Scoring System (IHS4-55) at 6 and 12 Months
The International Hidradenitis Suppurativa Severity Scoring System (IHS4) is a validated measure of HS severity. Disease severity is calculated by weighting different lesion types as follows: the IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + (number of draining tunnels [fistulae/sinuses] × 4).
A score of ≤3 indicates mild disease, a score of 4-10 indicates moderate disease, and a score of ≥11 indicates severe disease.
In this study, treatment response is assessed using IHS4-55, defined as a proportion of patients achieving ≥55% reduction in IHS4 score compared to baseline.
Measured: 6 and 12 months
Secondary outcomes (12)
Number and Percentage of Patients by Selected Demographic and Clinical Characteristics Overall and by Early and Late Treatment Group
Demographics and clinical characteristics (subject to availability in the data sources) include:
- Age category
- Sex
- Body mass index (BMI) category
- Smoking status
- Other medical conditions
- Family history of HS
- Year of HS diagnosis
- Year of secukinumab initiation
- Hurley stage
- Number of tunnels, nodules, abscesses
- Prior surgeries and procedures
- Prior treatment
Measured: Baseline
Duration of HS
Measured: Baseline
Mean Change From Baseline in IHS4 Score at 6 and 12 Months
The IHS4 is a validated measure of HS severity. Disease severity is calculated by weighting different lesion types as follows: the IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + (number of draining tunnels [fistulae/sinuses] × 4).
A score of ≤3 indicates mild disease, a score of 4-10 indicates moderate disease, and a score of ≥11 indicates severe disease.
Measured: Baseline, 6 and 12 months
Proportion of Patients Achieving 75% Reduction in IHS4 (IHS4-75) From Baseline at 6 and 12 Months
The IHS4 is a validated measure of HS severity. Disease severity is calculated by weighting different lesion types as follows: the IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + (number of draining tunnels [fistulae/sinuses] × 4).
A score of ≤3 indicates mild disease, a score of 4-10 indicates moderate disease, and a score of ≥11 indicates severe disease.
IHS4-75 is defined as a proportion of patients achieving ≥ 75% reduction in IHS4 score at 6 and 12 months compared to baseline.
Measured: 6 and 12 months
Proportion of Patients Achieving 100% Reduction in IHS4 (IHS4-100) From Baseline at 6 and 12 Months
The IHS4 is a validated measure of HS severity. Disease severity is calculated by weighting different lesion types as follows: the IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + (number of draining tunnels [fistulae/sinuses] × 4).
A score of ≤3 indicates mild disease, a score of 4-10 indicates moderate disease, and a score of ≥11 indicates severe disease.
IHS4-100 is defined as a proportion of patients achieving 100% reduction in IHS4 score at 6 and 12 months compared to baseline.
Measured: 6 and 12 months
Mean Change in Number of Inflammatory Abscesses, Nodules, and Active Tunnels From Baseline at 6 and 12 Months
Measured: Baseline, 6 and 12 months
Proportion of Patients Whose Disease Progresses From Baseline at 6 and 12 Months
Disease progression is defined as development of new tunnel(s) or development of new persistent HS lesions in an anatomical area not previously affected or increase in the number of persistent HS lesions in an affected anatomical region. Persistent lesions are defined as lesions sustained for ≥4 weeks.
Measured: 6 and 12 months
Mean Number of Flares From Baseline at 6 and 12 Months
Flare is defined as an increase of at least 25% in AN (abscess and inflammatory nodule) count with a minimum increase of 2 AN relative to baseline.
Measured: 6 and 12 months
Mean Change in Pain From Baseline at 6 and 12 Months
Patient-reported Numeric Rating Scale (NRS) skin pain score at 6 and/or 12 months, as recorded.
The Skin Pain NRS is a tool used to measure patient reported skin pain severity. Patients rate their worst skin pain over the past 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable).
Measured: Baseline, 6 and 12 months
Proportion of Patients Achieving ≥30% Reduction in Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS30)
The Skin Pain NRS is a tool used to measure patient reported skin pain severity. Patients rate their worst skin pain over the past 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable). An NRS30 response is defined as a ≥30% reduction and ≥2-point decrease in skin pain score from baseline.
Measured: 6 and 12 months
Proportion of Patients Who Required Surgery From Baseline at 6 and 12 Months
Any HS-related surgery (e.g., STEEP, wide excision, incision and drainage, deroofing) between baseline and at 6 and/or 12 months, as reported.
Measured: 6 and 12 months
Proportion of Patients Achieving a 5-point Reduction of Their Dermatology Life Quality Index (DLQI) Questionnaire From Baseline at 6 and 12 Months
The DLQI is a questionnaire designed to measure the impact of skin disease on a patient's health-related quality of life. It contains 10 simple, self-administered items. Each item is scored on a 4-point scale (0 = not at all to 3 = very much). The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start13 Nov 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690319
- Sponsor's protocol ID
- CAIN457M2007
- Acronym
- EARLY-HS 2
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Individual data sharing
- No