Short-term Treatment Satisfaction in Hidradenitis Suppurativa Patients Initiated on Cosentyx in Routine Clinical Practice in Saudi Arabia (ILLUMINATE-SA)

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.

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa (HS)
• Intervention / Treatment: Other: Secukinmab

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.

• Study Type: Observational
• Enrollment (Estimated): 77

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia, 21391
    • Recruiting
    • Novartis Investigative Site
  • Jeddah, Saudi Arabia, 23311
    • Recruiting
    • Novartis Investigative Site
  • Riyadh, Saudi Arabia, 11211
    • Recruiting
    • Novartis Investigative Site
  • SAU
    • Riyadh, SAU, Saudi Arabia, 11525
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

1. Male or Female adult patients ≥18 years of age at the time of data collection.
2. Patient with a confirmed diagnosis of active moderate to severe HS.
3. Secukinumab naive patients (first dose to coincide within one month of the signature of the informed consent) as per locally approved label.
4. Patients can be using antibiotics or have undergone surgery as per routine clinical practice.
5. Patients agree to sign an informed consent form (ICF) to be able to complete the questionnaires.

Exclusion Criteria:

1. Patients not fulfilling any of the above-mentioned inclusion criteria.
2. Patient's refusal to be included in the study or refusal to sign the ICF.
3. A history of off-label indication uses of biological treatment or JAK inhibitor.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Secukinumab; Patients who are newly initiated on Secukinumab	Other: Secukinmab; This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.; Other Names: Cosentyx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	Baseline, week 24
Baseline characteristics-age	Age at baseline (years)	Baseline
Baseline characteristics - Ethnicity	Assessment of Participant's ethnicity	Baseline
Baseline characteristics - Socio-economic status	Assessment of socio-economic status	Baseline
Baseline characteristics - smoking status	Assessment of smoking status	Baseline
Baseline characteristics - Family history of HS	Number of participants with family history of HS	Baseline
Baseline characteristics - Duration of the disease	Time since- symptom onset and/or diagnosis	Baseline
Baseline characteristics - Previous HS-related treatment	Number of participants with Previous HS- related treatment including treatment type	Baseline
Baseline characteristics - previous HS-related surgeries	Number of participants with Previous HS- related surgeries including surgery type	Baseline
Baseline characteristics - Current or previous use of antibiotic treatment	Number of participants with current or previous use of antibiotic treatment including antibiotic type.	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	Baseline
Baseline characteristics - concomitant medications	Assessment of concomitant medications	Baseline
Baseline characteristics - Hurley Stage	Classification of HS severity assessed by Hurley staging scale, Stage I (Mild) , Stage II (Moderate) and stage III (Severe)	Baseline
Baseline characteristics - number of inflammatory nodules, abscesses and draining tunnels/fistula	Number of inflammatory nodules, abscesses and draining tunnels/fistula	Baseline

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 21, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: NIS; Saudi Arabia; secukinumab; HS; Hidradenitis Suppurativa
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; secukinumab
• Other Study ID Numbers: CAIN457MSA01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO