Hidradenitis SuppurativaSPECTRANCT06444087
Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation
An observational study of Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 22 sites in France.
Trial summary
The primary objective of this non-interventional study is to describe the evolution of Hidradenitis suppurativa (HS) symptoms 12 months after secukinumab initiation based on the patients' assessment of pain, oozing, and bad smell. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- secukinumab
- How many people
- 192 participants
- Where
- 22 sitesFrance
- Study dates
- 17 Jun 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include male and female patients (aged ≥ 18 years) with a diagnosis of HS and for whom the decision to initiate treatment with secukinumab was made independently of the study.
Who may be able to join
- Male and female patients ≥ 18 years old,
- Patients who do not object to participation in the study,
- Diagnosis of HS clinically confirmed,
- Initiation of secukinumab treatment for HS in compliance with the summary of product characteristics,
- The physician's decision to initiate secukinumab has been taken according to his/her own practice and regardless of study participation.
Who cannot join
- Patients with any medical or psychological condition which, in the physician's opinion, may prevent participation in the study,
- Patients participating in a clinical trial.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
Novartis Investigative Site
Antony, 92160
Novartis Investigative Site
Bordeaux, 33075
Novartis Investigative Site
Brest, 29609
Novartis Investigative Site
Calais, 62100
Novartis Investigative Site
Dijon, 21000
Novartis Investigative Site
La Rochelle, 17019
Novartis Investigative Site
Le Mans, 72000
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Lorient, 56322
Novartis Investigative Site
Lyon, 69003
Novartis Investigative Site
Marseille, 13008
Novartis Investigative Site
Martigues, 13500
Novartis Investigative Site
Montpellier, 34090
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Nice, France, 06000
Novartis Investigative Site
Paris, 75014
Novartis Investigative Site
Rodez, 12000
Novartis Investigative Site
Rouen, 76031
Novartis Investigative Site
Saint-Mandé, 94160
Novartis Investigative Site
Saint-Pierre, 97410
Novartis Investigative Site
Toulouse, 31400
Novartis Investigative Site
Vannes, 56000
About this study
Official title: Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation: a French Multicentric Prospective Observational Study
The primary objective of this non-interventional study is to describe the evolution of Hidradenitis suppurativa (HS) symptoms 12 months after secukinumab initiation based on the patients' assessment of pain, oozing, and bad smell.
Read the detailed description
This study is a prospective (primary data), national, descriptive, non-interventional, multicentre study conducted by medical practice and hospital-based dermatologists across different geographical regions in France.
This real-world study does not change the physician-patient relationship or patient management or follow-up. Physicians remain free with their prescriptions and patient follow-up procedures. In fact, secukinumab initiation and all treatment decisions will be made according to routine medical care and independently of study participation.
Recruited patients will be longitudinally followed-up for the duration of the study, up to 24 months (± 3 months) after secukinumab initiation or secukinumab treatment discontinuation before the end of the 24 months of follow-up (early discontinuation).
- Conditions
- Hidradenitis Suppurativa
- Being tested
- secukinumab
- Keywords
- secukinumab, Hidradenitis Suppurativa, HS, NIS, France
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secukinumabOther
This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.
| Study group | Role | What they receive |
|---|---|---|
| secukinumab | Patients prescribed with secukinumab Receives: Other: secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving at least 30% reduction of the NRS score for at least one the assessed symptoms
Patients will provide an assessment of pain, oozing and bad smell based on three numeric rating scales (NRS). The most common form of the scale is a horizontal line with a numeric scale ranging from 0 to 10, 0 corresponding to "no symptoms" and 10 being the worst possible symptom. At each visit, these three assessments will cover the last seven days.
Measured: Baseline, month 12
Secondary outcomes (20)
Proportion of patients achieving at least a 30% reduction of NRS
Proportion of patients achieving at least a 30% reduction of NRS for at least one of the evaluated symptoms (pain, oozing and bad smell) and the proportion of patients achieving at least a 30% reduction of NRS for each symptom evaluated separately (pain, oozing and bad smell)
Measured: Baseline, month 3, month 6, month 18 and month 24
Proportion of patients achieving at least a 5-point reduction of the Dermatology Life Quality Index (DLQI)
The DLQI consists of ten questions regarding patients' perception of the impact of their disease on different aspects of their health-related quality of life (symptoms and feelings, impact on daily activities, leisure, work, school, personal relationships, and problems with treatment) over the last seven days. The highest possible total score for the DLQI is 30 and higher scores indicate a more severe impact on quality of life.
Measured: Baseline, month 3, month 6, month 18 and month 24
Proportion of patients maintaining the improvement up to 24 months of the response of the Impact of Hidradenitis Suppurativa on daily life compared to baseline
The impact of Hidradenitis Suppurativa (HS) on daily life will be studied using seven additional questions on the symptoms experienced by the patient and the impact of HS on daily life over the past three months: physical and psychological fatigue, anxiety, sleep quality, discomfort with dressing, discomfort with washing, and sex and love life. Responses will be collected at each visit by a four-point Likert scale. The improvement will be defined by the decrease of at least one point on the Likert scale between the enrolment visit and the follow-up visits.
Measured: Baseline, up to 24 months
Proportion of patients having stopped at tobacco, alcohol and cannabis use
The proportion of patients having stopped at least one of these substances during follow-up will be calculated, and as well as the proportion of patients having stopped one of these substances without using them again until the end of follow-up.
Measured: Baseline, month 3, month 6, month 18 and month 24
Absenteeism due to Hidradenitis Suppurativa
Absenteeism due to HS will be measured by the number of days off taken and the number of days on sick leave over the last three months (enrolment visit and visit at 3 months) or since the last visit (visits at 6, 12, 18 and 24 months). The number of days and its evolution since enrolment will be presented at each visit.
Measured: Baseline, month 3, month 6, month 18 and month 24
Proportion of patients achieving at least a 5-point reduction of FDLQI compared to the baseline
The family member's quality of life will be measured using the FDLQI. The FDLQI is a 10-item-questionnaire with a total score resulting in a maximum of 30 and a minimum of 0 (the higher the score, the more quality of life is impaired). The questionnaire will be proposed to one of the family members (one per patient, the same person throughout the study) going with the patient to the baseline visit and 3, 6, 12, 18 and 24 months after secukinumab initiation. The assessment will refer to the last seven days.
Measured: Baseline, month 3, month 6, month 18 and month 24
Secukinumab dose regimen prescribed at baseline
Secukinumab dose regimen prescribed at baseline to describe the use of secukinumab.
Measured: Baseline
Proportion of patients receiving up-titration or down-titration
Proportion of patients receiving up-titration (q4w-to-q2w) or down-titration (q2w-to-q4w) and proportion of patients receiving more than one up-and/or down-titration
Measured: Month 3, month 6, month 12, month 18 and month 24
Time spent under each treatment regimen
Time spent under each treatment regimen (q4w and q2w) and reason for change
Measured: Up to 24 months
Total duration of secukinumab treatment
Total duration of secukinumab treatment (i.e. time elapsed until treatment is discontinued), reason for discontinuation
Measured: Up to 24 months
Proportion of patients with at least one temporary discontinuation
Proportion of patients with at least one temporary discontinuation and its reason
Measured: Up to 24 months
Proportion of patients taking all prescribed doses
Proportion of patients taking all prescribed doses to measure the treatment compliance
Measured: Up to 24 months
Proportion of patients achieving a reduction in IHS4
Proportion of patients achieving at least 55%, 75% and 100% reduction in International Hidradenitis Suppurativa Severity Score System (IHS4) (IHS4-55, 75, 100).
The IHS4 score corresponds to: (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of drainage tunnels (fistulas/sinuses) multiplied by 4]. A score of 3 or less corresponds to mild HS, a score of 4 to 10 to moderate HS and a score of 11 or more to severe HS
Measured: Baseline, month 3, month 6, month 12, month 18 and month 24
Evolution of AN count
Evolution of AN count (total abscesses and inflammatory nodules)
Measured: Baseline, month 3, month 6, month 12, month 18 and month 24
Percentages of patients with onset or worsening of flares
Percentages of patients with onset or worsening of flares will be described from the data concerning flares collected by the physician at each visit.
Measured: Baseline, month 3, month 6, month 18 and month 24
Proportion of patients who achieved at least a 30% reduction in the NRS score (pruritus)
Itching due to pruritus will be evaluated using an 11-point NRS scale with 0 being "no itch" and 10 being the worst itch imaginable.
Measured: Baseline, month 3, month 6, month 18 and month 24
Proportion of patients receiving at least one medication for HS
Treatments of interest will include systemic antibiotics, pain medications and psychotropic drugs.
Measured: Month 3, month 6, month 18 and month 24
Proportion of patients who had a surgical procedure
Proportion of patients who had a surgical procedure will be provided
Measured: Up to 24 months
Proportion of patients with stable/increased/decreased dressing used since the baseline visit
Use of dressings and protections for wound care after secukinumab initiation, evaluated by the use of dressings and protections in the seven days prior to visits (data collected by the patient)
Measured: Baseline, month 3, month 6, month 18 and month 24
Number of patients by reasons for secukinumab initiation
Description of the reasons for secukinumab initiation (e.g.: patient complaints, clinical symptoms, safety events) declared by the participating physician.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start17 Jun 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 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
- Other
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
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
- NCT06444087
- Sponsor's protocol ID
- CAIN457MFR01
- Acronym
- SPECTRA
- Status last verified
- Jan 2026
- First submitted
- 30 May 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation: a French Multicentric Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06444087
- Acronym / sponsor ID
- SPECTRA / CAIN457MFR01
- Conditions
- Hidradenitis Suppurativa
- Keywords
- secukinumab, Hidradenitis Suppurativa, HS, NIS, France
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this non-interventional study is to describe the evolution of Hidradenitis suppurativa (HS) symptoms 12 months after secukinumab initiation based on the patients' assessment of pain, oozing, and bad smell.
Detailed description
This study is a prospective (primary data), national, descriptive, non-interventional, multicentre study conducted by medical practice and hospital-based dermatologists across different geographical regions in France.
This real-world study does not change the physician-patient relationship or patient management or follow-up. Physicians remain free with their prescriptions and patient follow-up procedures. In fact, secukinumab initiation and all treatment decisions will be made according to routine medical care and independently of study participation.
Recruited patients will be longitudinally followed-up for the duration of the study, up to 24 months (± 3 months) after secukinumab initiation or secukinumab treatment discontinuation before the end of the 24 months of follow-up (early discontinuation).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| secukinumab | – | Other: secukinumabPatients prescribed with secukinumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include male and female patients (aged ≥ 18 years) with a diagnosis of HS and for whom the decision to initiate treatment with secukinumab was made independently of the study.
Key inclusion criteria (5 listed)
- Male and female patients ≥ 18 years old,
- Patients who do not object to participation in the study,
- Diagnosis of HS clinically confirmed,
- Initiation of secukinumab treatment for HS in compliance with the summary of product characteristics,
- The physician's decision to initiate secukinumab has been taken according to his/her own practice and regardless of study participation.
Key exclusion criteria (2 listed)
- Patients with any medical or psychological condition which, in the physician's opinion, may prevent participation in the study,
- Patients participating in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| secukinumabThis is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement. | Other | secukinumab |
Primary outcome
Proportion of patients achieving at least 30% reduction of the NRS score for at least one the assessed symptoms
Time frame: Baseline, month 12
Patients will provide an assessment of pain, oozing and bad smell based on three numeric rating scales (NRS). The most common form of the scale is a horizontal line with a numeric scale ranging from 0 to 10, 0 corresponding to "no symptoms" and 10 being the worst possible symptom. At each visit, these three assessments will cover the last seven days.
20 secondary outcomes
Proportion of patients achieving at least a 30% reduction of NRS
Time frame: Baseline, month 3, month 6, month 18 and month 24
Proportion of patients achieving at least a 5-point reduction of the Dermatology Life Quality Index (DLQI)
Time frame: Baseline, month 3, month 6, month 18 and month 24
Proportion of patients maintaining the improvement up to 24 months of the response of the Impact of Hidradenitis Suppurativa on daily life compared to baseline
Time frame: Baseline, up to 24 months
Proportion of patients having stopped at tobacco, alcohol and cannabis use
Time frame: Baseline, month 3, month 6, month 18 and month 24
Absenteeism due to Hidradenitis Suppurativa
Time frame: Baseline, month 3, month 6, month 18 and month 24
Proportion of patients achieving at least a 5-point reduction of FDLQI compared to the baseline
Time frame: Baseline, month 3, month 6, month 18 and month 24
Secukinumab dose regimen prescribed at baseline
Time frame: Baseline
Proportion of patients receiving up-titration or down-titration
Time frame: Month 3, month 6, month 12, month 18 and month 24
Time spent under each treatment regimen
Time frame: Up to 24 months
Total duration of secukinumab treatment
Time frame: Up to 24 months
Proportion of patients with at least one temporary discontinuation
Time frame: Up to 24 months
Proportion of patients taking all prescribed doses
Time frame: Up to 24 months
Proportion of patients achieving a reduction in IHS4
Time frame: Baseline, month 3, month 6, month 12, month 18 and month 24
Evolution of AN count
Time frame: Baseline, month 3, month 6, month 12, month 18 and month 24
Percentages of patients with onset or worsening of flares
Time frame: Baseline, month 3, month 6, month 18 and month 24
Proportion of patients who achieved at least a 30% reduction in the NRS score (pruritus)
Time frame: Baseline, month 3, month 6, month 18 and month 24
Proportion of patients receiving at least one medication for HS
Time frame: Month 3, month 6, month 18 and month 24
Proportion of patients who had a surgical procedure
Time frame: Up to 24 months
Proportion of patients with stable/increased/decreased dressing used since the baseline visit
Time frame: Baseline, month 3, month 6, month 18 and month 24
Number of patients by reasons for secukinumab initiation
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
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Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
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ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 22 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving at least 30% reduction of the NRS score for at least one the assessed symptoms (time frame: Baseline, month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.