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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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

Other trials in United Arab Emirates

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).

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 groups in NCT06785675
Study groupRoleWhat they receive
SecukinumabPatients 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.

  1. 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)
  1. 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

  2. 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

  3. Age (years)

    Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab

    Measured: Baseline

  4. Gender (male/female)

    Characteristics of HS patients started on Secukinumab

    Measured: Baseline

  5. Ethnicity

    Characteristics of HS patients started on Secukinumab

    Measured: Baseline

  6. Weight (kilogram)

    Characteristics of HS patients started on Secukinumab

    Measured: Baseline

  7. Height (meters)

    Characteristics of HS patients started on Secukinumab

    Measured: Baseline

  8. Socio-economic status

    Characteristics of HS patients started on Secukinumab

    Measured: Baseline

  9. Smoking status

    Characteristics of HS patients started on Secukinumab

    Measured: Baseline

  10. Duration of the disease (time since diagnosis)

    Characteristics of HS patients started on Secukinumab

    Measured: Baseline

  11. Previous HS-related treatment

    Characteristics of HS patients started on Secukinumab

    Measured: Baseline

  12. 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

  13. Hurley Stage

    Characteristics of HS patients started on Secukinumab

    Measured: Baseline

  14. Number of inflammatory nodules, number of abscesses, and fistulas

    Characteristics of HS patients started on Secukinumab

    Measured: Baseline

  15. Previous HS-related surgeries

    Characteristics of HS patients started on Secukinumab

    Measured: Baseline

  16. Previous use of biologic treatment

    Characteristics of HS patients started on Secukinumab

    Measured: Baseline

  17. 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.

  1. First posted21 Jan 2025
  2. Study start10 Mar 2025
  3. Primary completion10 Oct 2026 (estimated)
  4. Study completion10 Oct 2026 (estimated)

Resources

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)
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

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