Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Psoriasis

Moderate-to-severe Plaque Psoriasis Clinical Trial

— SPARROW  

Official title:

Prospective Observational Study With Retrospective Part to Evaluate Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Moderate-to-severe Plaque Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142357
• Other study ID #: CAIN457LRU01
• Status: Recruiting
• Start date: December 29, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Multicenter, non-interventional, cohort study in pediatric patients with moderate to severe plaque-type psoriasis. Retrospective data collection is planned at patients' inclusion.

Description:

This observational study will be performed at healthcare facilities treating pediatric psoriasis patients. The study population will consist of a representative group of pediatric patients with moderate-to-severe plaque psoriasis for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 16 weeks Retrospective data collection is planned at patients' inclusion. Prospective data collection will continue during follow-up routine visits until secukinumab discontinuation or maximum duration of follow-up for 104 weeks after index date.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Written informed consent and legal representative's permission for study participation obtained prior to beginning of participation in the study.

2. Age =6 to <18 years old.

3. Established diagnosis of active moderate-to-severe plaque psoriasis defined as a PASI score = 10, body surface area (BSA) involvement of =10% and PGA score = 3 only or with concomitant psoriatic arthritis.

4. Failure or intolerance of prior psoriasis treatment.

5. Patient was prescribed with secukinumab within 4-16 weeks before inclusion.

6. Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of this non-interventional study conduct.

Exclusion Criteria:

1. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).

2. History of chronic recurrent infection.

3. Clinically significant infection exacerbation, including active tuberculosis.

4. Age <6 years or =18 years.

5. Pregnancy and breastfeeding.

6. Patients participating in parallel in an interventional clinical trial.

7. Patients participating in parallel in other Novartis-sponsored non-interventional study generating primary data for secukinumab.

8. Patients within the safety follow-up phase of interventional study.

9. Active inflammatory bowel disease at inclusion.

10. Patients who received any vaccine within 4 weeks prior to secukinumab initiation.

11. Any medical or psychological condition in the investigator's opinion which may prevent the study participation.

Related Conditions & MeSH terms

• Moderate-to-severe Plaque Psoriasis
• Psoriasis

Intervention

Other:
• Secukinumab
There is no treatment allocation. Patients administered secukinumab by prescription will be enrolled

Locations

Country	Name	City	State
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Grozny
Russian Federation	Novartis Investigative Site	Izhevsk
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Mytishchi
Russian Federation	Novartis Investigative Site	Nizhny Novgorod
Russian Federation	Novartis Investigative Site	Rostov On Don
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Russian Federation	Novartis Investigative Site	Tula
Russian Federation	Novartis Investigative Site	Yakutsk

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug survival rate of secukinumab	Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab (defined as =2 missed consecutive doses with drug discontinuation proved by investigator in eCRF).	52 weeks
Secondary	Secukinumab survival rates	Secukinumab survival rate is defined as proportion of patients who have not discontinued treatment due to reasons other than lack of efficacy.	Week 24, week 52, and week 104 after the index date
Secondary	Time to treatment discontinuation due to ineffectiveness	Time from index date to treatment discontinuation due to ineffectiveness	Week 12, week 24, week 52, week 104
Secondary	Proportion of patients achieving PASI 75 responses	Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis.; A PASI 75 represents an improvement in the PASI score of at least 75% as compared with baseline.	Baseline (study inclusion), week 24, week 52, and week 104 after the index date
Secondary	Proportion of patients achieving PASI 90 responses	Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis.; A PASI 90 represents an improvement in the PASI score of at least 90% as compared with baseline.	Baseline (study inclusion), week 24, week 52, and week 104 after the index date
Secondary	Proportion of patients achieving PASI 100 responses	Psoriasis Area and Severity Index (PASI) takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis.; A PASI 100 response corresponds to complete clearing of psoriasis (PASI = 0).	Baseline (study inclusion), week 24, week 52, and week 104 after the index date
Secondary	Proportion of patients achieving a physicians' global assessment (PGA) 0/1 response	Proportion of patients achieving a physicians' global assessment 0/1 response: clear/almost clear skin	Baseline (study inclusion), week 24, week 52, and week 104 after the index date
Secondary	Adverse events (AEs) of special interest	Adverse events (AEs) of special interest: Inflammatory Bowel Disease, malignancy, tuberculosis, serious infections, candidiasis, acute injection site reaction, immunogenicity	Week 12, week 24, week 52, week 104 after the index date
Secondary	Proportion of patients discontinued secukinumab by reason	Proportion of patients discontinued secukinumab by reason: Lack of efficacy; Adverse events; Administrative reasons (no medication available in the hospital, etc.); Lack of patient's adherence; Patient's or legal representative's wish; Other	Week 12, week 24, week 52 and week 104
Secondary	Drug survival rate	Drug survival is defined as time from the index date (defined as secukinumab treatment initiation) until discontinuation of secukinumab (defined as =2 missed consecutive doses with drug discontinuation proved by investigator in eCRF).	104 weeks