Hidradenitis Suppurativa (HS)ILLUMINATE-SANCT06785779
Short-term Treatment Satisfaction in Hidradenitis Suppurativa Patients Initiated on Cosentyx in Routine Clinical Practice in Saudi Arabia
An observational study of Hidradenitis Suppurativa (HS), run by Novartis Pharmaceuticals at 4 sites in Saudi Arabia.
Trial summary
This study aims to assess the treatment satisfaction of HS patients newly started on secukinumab in Saudi Arabia, in terms of patient reported convenience, perceived safety, perceived effectiveness and global treatment satisfaction as measured by the treatment satisfaction questionnaire for medication (TSQM) at week… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- Secukinmab
- How many people
- 77 participants
- Where
- 4 sitesSaudi Arabia
- Study dates
- 10 Mar 2025to 30 Sep 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 who are newly initiated on Secukinumab as per locally approved labels and routine clinical practice will be enrolled over a period of 6 months and followed up for 24 weeks to assess study outcomes
Who may be able to join
- Male or Female adult patients ≥18 years of age at the time of data collection.
- Patient with a confirmed diagnosis of active moderate to severe HS.
- Secukinumab naive patients (first dose to coincide within one month of the signature of the informed consent) as per locally approved label.
- Patients can be using antibiotics or have undergone surgery as per routine clinical practice.
- Patients agree to sign an informed consent form (ICF) to be able to complete the questionnaires.
Who cannot join
- Patients not fulfilling any of the above-mentioned inclusion criteria.
- Patient's refusal to be included in the study or refusal to sign the ICF.
- A history of off-label indication uses of biological treatment or JAK inhibitor.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
Saudi Arabia4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Jeddah, 21391
- Recruiting
Novartis Investigative Site
Jeddah, 23311
- Recruiting
Novartis Investigative Site
Riyadh, SAU, 11525
- Recruiting
Novartis Investigative Site
Riyadh, 11211
About this study
Official title: Survey Assessing Prospective Patient's Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Cosentyx (Secukinumab) in Routine Clinical Practice in Saudi Arabia: ILLUMINATE-SA
This study aims to assess the treatment satisfaction of HS patients newly started on secukinumab in Saudi Arabia, in terms of patient reported convenience, perceived safety, perceived effectiveness and global treatment satisfaction as measured by the treatment satisfaction questionnaire for medication (TSQM) at week 24 among moderate to severe HS patients.
Read the detailed description
This is a 24-week longitudinal single arm prospective study based on data collected from electronic medical records (EMRs) and patient-reported outcomes questionnaires (TSQM, DLQI, and NPRS-11) to evaluate patient-reported satisfaction and early QoL experiences among HS adult patients who are newly administering Secukinumab as per routine clinical practice.
Data will be captured from both data sources (EMRs and Questionnaires) at the following time points (+/- 1 month):
- Baseline (index date: initiation of Secukinumab),
- 24 weeks.
This is in line with the frequency of routine follow-up visits and as per the standard of care to report on pre-defined outcomes in a representative HS population across Saudi Arabia.
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- Secukinmab
- Keywords
- Hidradenitis Suppurativa, HS, secukinumab, NIS, Saudi Arabia
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinmabOther
Also called Cosentyx
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 who are newly initiated on Secukinumab Receives: Other: Secukinmab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Score in the Treatment Satisfaction Questionnaire (TSQM)
TSQM questionnaire consists of 14 questions with a score ranging from 0 to 100. The questionnaire has four subscales, effectiveness (3 questions), side Effects (5 questions), convenience (3 questions) and global Satisfaction (3 questions).
TSQM scoring is calculated by each subscale, which ranges from 0 to 100, with higher scores indicating higher patient satisfaction with medication.
Measured: Week 24
Secondary outcomes (15)
Mean change from baseline in patient-reported QoL via the Dermatology Life Quality Index (DLQI) Questionnaire
The DLQI is a valid 10-item instrument used to measure the impact of skin diseases on a patient's quality of life. Each question is scored on a scale of 0 to 3, with 0 indicating "not at all" and 3 indicating "very much." The total score ranges from 0 to 30, with a higher score indicating a greater impact on the patient's quality of life.
Measured: Baseline, week 24
Mean change from baseline to week 24 in the Numeric Pain Rating Scale (NPRS-11)
NPRS-11 is a subjective measure representing pain intensity in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)
Measured: Baseline, week 24
Baseline characteristics-age
Age at baseline (years)
Measured: Baseline
Baseline characteristics - Ethnicity
Assessment of Participant's ethnicity
Measured: Baseline
Baseline characteristics - Socio-economic status
Assessment of socio-economic status
Measured: Baseline
Baseline characteristics - smoking status
Assessment of smoking status
Measured: Baseline
Baseline characteristics - Family history of HS
Number of participants with family history of HS
Measured: Baseline
Baseline characteristics - Duration of the disease
Time since- symptom onset and/or diagnosis
Measured: Baseline
Baseline characteristics - Previous HS-related treatment
Number of participants with Previous HS- related treatment including treatment type
Measured: Baseline
Baseline characteristics - previous HS-related surgeries
Number of participants with Previous HS- related surgeries including surgery type
Measured: Baseline
Baseline characteristics - Current or previous use of antibiotic treatment
Number of participants with current or previous use of antibiotic treatment including antibiotic type.
Measured: Baseline
Baseline characteristics - Time since diagnosis to first treatment and secukinumab treatment
Time from diagnosis to start the first treatment and Time from diagnosis to start of Secukinumab
Measured: Baseline
Baseline characteristics - concomitant medications
Assessment of concomitant medications
Measured: Baseline
Baseline characteristics - Hurley Stage
Classification of HS severity assessed by Hurley staging scale, Stage I (Mild) , Stage II (Moderate) and stage III (Severe)
Measured: Baseline
Baseline characteristics - number of inflammatory nodules, abscesses and draining tunnels/fistula
Number of inflammatory nodules, abscesses and draining tunnels/fistula
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 completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies 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
- Prospective
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785779
- Sponsor's protocol ID
- CAIN457MSA01
- Acronym
- ILLUMINATE-SA
- Status last verified
- Dec 2025
- First submitted
- 13 Jan 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Individual data sharing
- No