Hidradenitis SuppurativaNCT06785675
Assessing Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Secukinumab.
An observational study of Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 4 sites in United Arab Emirates.
Trial summary
This study will be conducted to address the lack of concrete data on the impact of pharmaceutical intervention on short-term patient satisfaction and quality of life (QoL) in patients with Hidradenitis Suppurativa (HS) in real-world settings, especially in the Gulf Region. 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
- 53 participants
- Where
- 4 sitesUnited Arab Emirates
- Study dates
- 10 Mar 2025to 10 Oct 2026
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Hidradenitis Suppurativa who are newly initiated on Secukinumab, across the United Arab Emirates.
Who may be able to join
- Patient with a confirmed diagnosis of active moderate to severe HS (Hurley Score 2-3)
- Male or Female adult patients ≥ 18 years of age at the time of data collection
- Patient newly initiated on Secukinumab (first dose to coincide within 1 month of the signature of the informed consent)
- Patients with a diagnosis of HS who are currently using antibiotics/ have undergone surgery or not as part of their routine clinical management are eligible for inclusion.
- Patients with a diagnosis of HS who have a history of previous treatment with Adalimumab or any other anti-TNF agent as part of their routine clinical management or biologic naïve are eligible for inclusion.
- Agreed to sign an informed consent to be able to fill in the questionnaires.
Who cannot join
- Patients not fulfilling any of the abovementioned inclusion criteria.
- Patient's refusal to be included in the study or refusal to sign the informed consent.
Trial locations and contacts
4 sites in 1 country.
United Arab Emirates4 sites
Novartis Investigative Site
Abu Dhabi
Novartis Investigative Site
Al Ain Abu Dhabi, United Arab Emirates
Novartis Investigative Site
Ras al-Khaimah
Novartis Investigative Site
Sharjah city
About this study
Official title: Assessing Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Secukinumab in Routine Clinical Practice in the United Arab Emirates: ILLUMINATE-HS, a Prospective Patient Surve
This study will be conducted to address the lack of concrete data on the impact of pharmaceutical intervention on short-term patient satisfaction and quality of life (QoL) in patients with Hidradenitis Suppurativa (HS) in real-world settings, especially in the Gulf Region.
Read the detailed description
This is a 24-week longitudinal single-arm prospective study based on data collected from EMRs along with patient-reported outcomes questionnaires (TSQM and DLQI) to evaluate patient-reported satisfaction and early quality of life experiences among HS patients who are newly initiated on Secukinumab. We will be using questionnaires at baseline and at week 24 to report on pre-defined outcomes in a representative HS population across the United Arab Emirates. The data will be collected using an electronic Case Report Form (eCRF) from both data sources (Electronic Medical Report and Questionnaires).
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Secukinumab
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Patients who are newly initiated on treatment with Secukinumab Receives: Other: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire
TSQM scoring is calculated by domain, and each domain score is computed by summing the individual TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher patient satisfaction.
4 Domains:
Effectiveness Side Effects Convenience Global Satisfaction
Measured: At Week 24
Secondary outcomes (17)
Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire
DLQI is a questionnaire designed to measure the impact of skin conditions on a patient's health-related quality of life. It contains 10 simple, self-administered questions. Focuses on the past week's experiences related to the skin condition. Each question uses a 4-point Likert scale: "Not at all," "A little," "A lot," "Very much."
Measured: Baseline, Week 24
Change from baseline in the Numerical Rating Scale (NRS)
The NRS is commonly used for measuring pain intensity and is well validated. It is scored from 0-10 (0 meaning no pain and 10 meaning the worst pain imaginable).
Measured: Baseline, Week 24
Age (years)
Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab
Measured: Baseline
Gender (male/female)
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Ethnicity
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Weight (kilogram)
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Height (meters)
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Socio-economic status
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Smoking status
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Duration of the disease (time since diagnosis)
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Previous HS-related treatment
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Time since diagnosis to start of the first treatment, and from time since diagnosis to start of Secukinumab
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Hurley Stage
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Number of inflammatory nodules, number of abscesses, and fistulas
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Previous HS-related surgeries
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Previous use of biologic treatment
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Previous and current use of antibiotics treatment
Characteristics of HS patients started on Secukinumab
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start10 Mar 2025
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Oct 2026 (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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785675
- Sponsor's protocol ID
- CAIN457AAE02
- Status last verified
- Jun 2026
- First submitted
- 27 Nov 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No