Psoriasis VulgarisNCT05215561
Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP
An observational study of Psoriasis Vulgaris and Psoriatic Arthritis, run by Novartis Pharmaceuticals at 21 sites in Japan.
Trial summary
This was a multicenter, centrally registered observational study without a control group. This observational study was a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during the observation period (52 weeks after the start of treatment with this drug) in pediatric… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Psoriasis Vulgaris, Psoriatic Arthritis, Pustular Psoriasis
- What is being tested?
- Cosentyx
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- 21 sitesJapan
- Study dates
- 14 Feb 2022to 28 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patients who received Cosentyx
Who may be able to join
- Patients who have obtained written consent from their legally acceptable representative to cooperate in this survey before the start of treatment with this drug
- Patients aged less than 18 years at the start of treatment with this drug
- Patients newly treated with this drug for any of the following diseases: Psoriasis vulgaris, psoriatic arthritis, pustular psoriasis
Who cannot join
- Prior treatment with this drug
- Participation in an interventional study (e.g., a clinical trial) at the time of starting this drug.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Japan21 sites
Novartis Investigative Site
Akita, 010-8543
Novartis Investigative Site
Chuo Ku, Tokyo, 104 8560
Novartis Investigative Site
Fukuoka, Fukuoka, 814 0180
Novartis Investigative Site
Ikoma, Nara, 630-0293
Novartis Investigative Site
Kahoku-gun, Ishikawa-ken, 920-0293
Novartis Investigative Site
Kamigyō-ku, Kyoto, 602-8026
Novartis Investigative Site
Kitakyushu, Fukuoka, 807-8556
Novartis Investigative Site
Kyoto, Kyoto, 602-8566
Novartis Investigative Site
Kyoto, 616-8313
Novartis Investigative Site
Mito, Ibaraki, 310-0015
Novartis Investigative Site
Moriguchi, Osaka, 570-8507
Novartis Investigative Site
Nagoya, Aichi-ken, 467-8602
Novartis Investigative Site
Obihiro, Hokkaido, 080 0013
Novartis Investigative Site
Ōsaka-sayama, Osaka, 589 8511
Novartis Investigative Site
Sakai, Osaka, 591 8025
Novartis Investigative Site
Sapporo, Hokkaido, 064-0807
Novartis Investigative Site
Sendai, Miyagi, 983 8512
Novartis Investigative Site
Shinjuku Ku, Tokyo, 160-0023
Novartis Investigative Site
Sumida-Ku, Tokyo, 130-8587
Novartis Investigative Site
Takatsuki, Osaka, 569-8686
Novartis Investigative Site
Wakayama, 641-0051
About this study
Official title: A Special Drug Use-results Survey to Evaluate the Safety and Efficacy of Subcutaneous Administration of Cosentyx in Pediatric Patients With Psoriasis Vulgaris, Psoriatic Arthritis, or Pustular Psoriasis
This was a multicenter, centrally registered observational study without a control group. This observational study was a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during the observation period (52 weeks after the start of treatment with this drug) in pediatric patients with psoriasis vulgaris, psoriatic arthritis, or pustular psoriasis who received this drug.
Read the detailed description
For patients who discontinued or completed this drug before the end of the observation period, the investigator recorded adverse events that occurred within 30 days after the day following the last administration of this drug, or the day of discontinuation of the survey (the day when discontinuation of the survey was judged), whichever is later, in the CRF.
If a patient withdraw consent, information was collected during the observation period up to the date of consent withdrawal.
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis, Pustular Psoriasis
- Being tested
- Cosentyx
- Keywords
- psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, NIS, Japan, Cosentyx, pediatric
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CosentyxOther
There was no treatment allocation. Patients administered Cosentyx by prescription that had started before inclusion of the patient into the study were enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Cosentyx | Cosentyx for Subcutaneous Injection Receives: Other: Cosentyx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events
Incidence of SAEs was collected
Measured: 52 weeks
Secondary outcomes (9)
Subjects with psoriasis vulgaris and psoriatic arthritis: IGA mod 2011 with 0 or 1 response
Investigator's Global Assessment (IGA) rating scale is:
0 - no signs of psoriasis. Postinflammatory hyperpigmentation may be present.
- - Normal to pink lesions, no thickening, focal scaling absent or minimal
- - Pink to pale red lesions, minimal to mild thickening, and mainly fine scaling.
- - Clearly distinguishable erythema of dull red to bright red, clearly distinguishable to moderate thickening, moderate scaling.
- - Light red to dark red lesions, high thickness with hard margins, high/rough scaling covering almost all or all lesions.
Measured: Baseline, week 4, week 12, week 24 and week 52
Subjects with psoriasis vulgaris and psoriatic arthritis: PASI 75/90/100 response
Psoriasis Area and Severity Index (PASI) 75/90 response is defined as ≥ 75%, ≥ 90% improvement (reduction) in PASI score compared to Baseline.
PASI 100 response means no sign of body psoriasis.
Measured: Baseline, week 4, week 12, week 24 and week 52
All patients: Change from baseline in CDLQI
Children's Dermatology Life Quality Index (CDLQI) is a global dermatology disability index designed to assess health-related quality of life in pediatric patients and consists of 10 questions about symptoms and feelings, leisure, school and holidays, personal relationships, sleep, and treatment. The total CDLQI score is the sum of 10 questions and ranges from 0 ~ 30. Higher scores indicate more impairment of health-related quality of life.
Measured: Baseline, week 4, week 12, week 24 and week 52
Subjects with psoriatic arthritis: Change from baseline in C-HAQ
Childhood Health Assessment Questionnaire (C-HAQ) is used to assess the QOL of patients with psoriatic arthritis.
The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other "activities". Higher scores mean worse quality of life.
Measured: Baseline, week 4, week 12, week 24 and week 52
Subjects with psoriatic arthritis: Change from baseline in JADAS -27
Juvenile Arthritis Disease Activity Score (JADAS) score was used to assess disease activity in patients with juvenile idiopathic arthritis including psoriatic arthritis. The investigator assessed each of the 4 components of the JADAS for patients with psoriatic arthritis (Rater's Global Assessment, Patient's or guardian's global assessment, Number of active arthritis and CRP) and record the results in the CRF. JADAS-27 is the sum of the 4 scores (0 ~ 57).
Measured: Baseline, week 4, week 12, week 24 and week 52
Subjects with pustular psoriasis: Change from Baseline in the Japanese Dermatological Association (JDA) Severity Index
The investigator determined the severity based on the areas of erythema with pustules, areas of erythema (total), areas of edema, fever, WBC count, CRP, and serum albumin. The total score in the severity index is divided into 0 ~ 17 points (1 ~ 6 = mild, 7 ~ 10 = moderate, 11 ~ 17 = severe).
Measured: Baseline, week 4, week 12, week 24 and week 52
Subjects with pustular psoriasis: General improvement in GPP
GPP: Generalized Pustular Psoriasis The investigator assessed the General improvement rating (Responder, partial-responder, non-responder, aggravated, indeterminate) of pustular psoriasis symptoms at each observation time point compared to the start of treatment with this drug.
Measured: Baseline, week 4, week 12, week 24 and week 52
Incidence of adverse events and adverse drug reactions
Incidence of AEs and ADRs was collected
Measured: 52 weeks
Incidence of adverse events and adverse reactions included in the safety specifications
Important identified risks or important potential risks specified in the Risk Management Plan at the time of planning the surveillance were determined to be identified in the surveillance. The following items were set as the safety specifications for the surveillance:
- Serious infections
- Neutrophil count decreased
- Hypersensitivity Reactions
- inflammatory bowel disease
- Erythroderma (exfoliative dermatitis)
- Malignancies
- Cardiovascular/cerebrovascular events
- Tuberculosis
- Events related to suicide/self-injury
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start14 Feb 2022
- Primary completion28 Sep 2024
- Study completion28 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215561
- Sponsor's protocol ID
- CAIN457L1401
- Status last verified
- Jun 2025
- First submitted
- 19 Jan 2022
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Special Drug Use-results Survey to Evaluate the Safety and Efficacy of Subcutaneous Administration of Cosentyx in Pediatric Patients With Psoriasis Vulgaris, Psoriatic Arthritis, or Pustular Psoriasis
- ClinicalTrials.gov ID
- NCT05215561
- Acronym / sponsor ID
- CAIN457L1401
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis, Pustular Psoriasis
- Keywords
- psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, NIS, Japan, Cosentyx, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 28 Sep 2024 (actual)
- Study completion
- 28 Sep 2024 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a multicenter, centrally registered observational study without a control group. This observational study was a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during the observation period (52 weeks after the start of treatment with this drug) in pediatric patients with psoriasis vulgaris, psoriatic arthritis, or pustular psoriasis who received this drug.
Detailed description
For patients who discontinued or completed this drug before the end of the observation period, the investigator recorded adverse events that occurred within 30 days after the day following the last administration of this drug, or the day of discontinuation of the survey (the day when discontinuation of the survey was judged), whichever is later, in the CRF.
If a patient withdraw consent, information was collected during the observation period up to the date of consent withdrawal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cosentyx | – | Other: CosentyxCosentyx for Subcutaneous Injection |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patients who received Cosentyx
Key inclusion criteria (3 listed)
- Patients who have obtained written consent from their legally acceptable representative to cooperate in this survey before the start of treatment with this drug
- Patients aged less than 18 years at the start of treatment with this drug
- Patients newly treated with this drug for any of the following diseases: Psoriasis vulgaris, psoriatic arthritis, pustular psoriasis
Key exclusion criteria (2 listed)
- Prior treatment with this drug
- Participation in an interventional study (e.g., a clinical trial) at the time of starting this drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CosentyxThere was no treatment allocation. Patients administered Cosentyx by prescription that had started before inclusion of the patient into the study were enrolled. | Other | Cosentyx |
Primary outcome
Incidence of serious adverse events
Time frame: 52 weeks
Incidence of SAEs was collected
9 secondary outcomes
Subjects with psoriasis vulgaris and psoriatic arthritis: IGA mod 2011 with 0 or 1 response
Time frame: Baseline, week 4, week 12, week 24 and week 52
Subjects with psoriasis vulgaris and psoriatic arthritis: PASI 75/90/100 response
Time frame: Baseline, week 4, week 12, week 24 and week 52
All patients: Change from baseline in CDLQI
Time frame: Baseline, week 4, week 12, week 24 and week 52
Subjects with psoriatic arthritis: Change from baseline in C-HAQ
Time frame: Baseline, week 4, week 12, week 24 and week 52
Subjects with psoriatic arthritis: Change from baseline in JADAS -27
Time frame: Baseline, week 4, week 12, week 24 and week 52
Subjects with pustular psoriasis: Change from Baseline in the Japanese Dermatological Association (JDA) Severity Index
Time frame: Baseline, week 4, week 12, week 24 and week 52
Subjects with pustular psoriasis: General improvement in GPP
Time frame: Baseline, week 4, week 12, week 24 and week 52
Incidence of adverse events and adverse drug reactions
Time frame: 52 weeks
Incidence of adverse events and adverse reactions included in the safety specifications
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Vulgaris and Psoriatic Arthritis, run by Novartis Pharmaceuticals at 21 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.