PsoriasisPhase 3IPSI-PSONCT02595970

Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis

A Phase 3 study testing Secukinumab in people with Psoriasis, run by Novartis Pharmaceuticals at 17 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety, tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus extension) in patients with moderate to severe… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Psoriasis
What is being tested?: Secukinumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 17 sitesFrance
Study dates: 20 May 2015to 9 Feb 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients with a history of chronic, moderate to severe plaque psoriasis (PASI ≥12; BSA (body surface area) ≥10 and IGA mod 2011 (Investigator's Global Assessment) ≥3) for at least 6 months
patient candidates for systemic therapy.
informed consent.

Who cannot join

previous treatment with agent targeting IL-17 (interleukine-17) or IL-17 receptor.
recent treatment with topical treatment (2 weeks), systemic agents (4 weeks for methotrexate, Ciclosporine A; systemic retinoids and other systemic treatment), TNF (tumor necrosis factor) inhibitors (3 months) or IL-12/23 inhibitors (6 months).

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

France17 sites

Novartis Investigative Site
Amiens, 80054
Novartis Investigative Site
Antony, 92160
Novartis Investigative Site
Argenteuil, 95107
Novartis Investigative Site
Bordeaux, 33076
Novartis Investigative Site
Brest, 29609
Novartis Investigative Site
La Rochelle, 17019
Novartis Investigative Site
Le Mans, Cedex 09, 72037
Novartis Investigative Site
Limoges, Haute Vienne, 87000
Novartis Investigative Site
Marseille, 13885
Novartis Investigative Site
Martigues, 13500
Novartis Investigative Site
Metz, 57077
Novartis Investigative Site
Nice, 06202
Novartis Investigative Site
Paris, 75014
Novartis Investigative Site
Paris, 75877
Novartis Investigative Site
Rouen, 76031
Novartis Investigative Site
Toulon, Val De Marne, 83800
Novartis Investigative Site
Toulouse, 31400

Other trials in France

About this study

Official title: A 52-week (Plus Extension Until Commercialization), Single-arm Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI) at 16 Weeks, as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Participants Suffering From Moderate to Severe Psoriasis

Read the detailed description

Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis

Conditions: Psoriasis
Being tested: Secukinumab
Keywords: Psoriasis, Secukinumab, Simplified Psoriasis Index, CAIN457A, AIN457AFR01, AIN457A, Skin condition, skin disease, itching condition, psoriasis vulgaris, relapsing/remitting psoriasis, immune-mediated systemic disease, skin lesions, red skin lesions, scaly patches, papules, plaques, itching
Medical subject headings: Psoriasis, Skin Diseases, Recurrence, Plaque, Amyloid, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SecukinumabDrug
Also called open label, no other intervention
weekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016.

Study groups in NCT02595970
Study group	Role	What they receive
Secukinumab	Experimental	Weekly sub cutaneous injections of 300 mg during the first month and then Monthly until Week 52 plus extension until 03/11/2016. Receives: Drug: Secukinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

proSPI (s) at Week 16 Compared to Baseline
The primary efficacy outcome of this study evaluates the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed for the purpose of this study.
Measured: Week 0 (baseline) to 16 weeks
Changes of saSPI (s) at Week 16 Compared to Baseline
The primary efficacy objective of the study was to evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed. proSPI (s) score range is 0 to 50. Higher score means worse condition
Measured: Week 0 (baseline) to 16 weeks

Secondary outcomes (9)

PASI (Psoriasis Area Severity Index) Score
PASI administered by a professional score range: 0 (no disease) to 72 (maximal disease)
Measured: week 0, 16, 52
Correlation Between PASI and proSPI (s)
Psoriasis Area Severity Index vs Professional Version of Simplified Psoraisis Index (proSPI) score
Measured: week 0, 16, 52
proSPI (s, p and i) Over Time
Professional Version of Simplified Psoriasis Index (proSPI)
SPI for Simplified Psoriasis Index. SPI is composed of 3 domains :
- s for the severity, min =0 and max=50
- p for the psychosocial, min=0 and max=10
- i for the intervention, min = 0 and max = 10 For each domain, high values represented a worse outcome The 3 subscales cannot be combined Please use sore on a scale for the unit of measure
Measured: weeks 0, 16, 52
saSPI (s, p and i) Over Time
Self-administered Simplified Psoriasis Index (saSPI)
SPI for Simplified Psoriasis Index. SPI is composed of 3 domains :
- s for the severity, min =0 and max=50
- p for the psychosocial, min=0 and max=10
- i for the intervention, min = 0 and max = 10 For each domain, high values represented a worse outcome The 3 subscales cannot be combined Please use sore on a scale for the unit of measure
Measured: weeks 0, 16, 52
DLQI (Dermatology Life Quality Index) Over Time
DLQI score has a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired
MEANING OF DLQI SCORES 0 - 1 no effect on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life
Measured: weeks 0, 16, 52
Self-administered PASI (SA-PASI)
self-administered PASI (SA-PASI) score
Measured: weeks 0, 16, 52
Psoriasis Symptom Diary (PSD) Score
assessment of pain, itching and scaling using the Psoriasis Symptom Diary questionnaire over time
PSD scores range from 0 to 10, with higher scores indicating a worse condition for each assessment: pain, itching and scaling
Measured: weeks 0, 16, 52
Correlation Between proSPI (for Each Component: s, p and i) and DLQI
Correlation between proSPI (for each component: s, p and i) and DLQI is summarized in table below
Measured: weeks 0, 16, 52
Correlation Between proSPI (for Components p and i) and PASI
Correlation between proSPI (p, i) and PASI score by visit (Full Analysis Set (observed)) is summarized in table below
Measured: Over time (from Week 0 to Week 52)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 20159 Feb 2017

First posted4 Nov 2015 (estimated)
Study start20 May 2015
Primary completion9 Feb 2017
Study completion9 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PsoriasisStudies 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02595970
Sponsor's protocol ID: CAIN457AFR01
Acronym: IPSI-PSO
Status last verified: Apr 2019
First submitted: 25 Feb 2015
Last updated: 17 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis: A Prospective Randomized Controlled Study.
Psoriasis, Psoriasis Genital
Enrolling by invitation
Combined High-Intensity Aerobic Training and Resistance Training in Psoriatic Arthritis
Psoriatic Arthritis
RecruitingPhase 2
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 52-week (Plus Extension Until Commercialization), Single-arm Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI) at 16 Weeks, as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Participants Suffering From Moderate to Severe Psoriasis
ClinicalTrials.gov ID: NCT02595970
Acronym / sponsor ID: IPSI-PSO / CAIN457AFR01
Conditions: Psoriasis
Keywords: Psoriasis, Secukinumab, Simplified Psoriasis Index, CAIN457A, AIN457AFR01, AIN457A, Skin condition, skin disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 20 May 2015 (actual)
Primary completion: 9 Feb 2017 (actual)
Study completion: 9 Feb 2017 (actual)
First posted: 4 Nov 2015 (estimated)
Results: Posted 17 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Secukinumab	Experimental	Drug: SecukinumabWeekly sub cutaneous injections of 300 mg during the first month and then Monthly until Week 52 plus extension until 03/11/2016.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

patients with a history of chronic, moderate to severe plaque psoriasis (PASI ≥12; BSA (body surface area) ≥10 and IGA mod 2011 (Investigator's Global Assessment) ≥3) for at least 6 months
patient candidates for systemic therapy.
informed consent.

Key exclusion criteria (2 listed)

previous treatment with agent targeting IL-17 (interleukine-17) or IL-17 receptor.
recent treatment with topical treatment (2 weeks), systemic agents (4 weeks for methotrexate, Ciclosporine A; systemic retinoids and other systemic treatment), TNF (tumor necrosis factor) inhibitors (3 months) or IL-12/23 inhibitors (6 months).

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
SecukinumabAlso: open label, no other interventionweekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016.	Drug	Secukinumab

Primary outcome

proSPI (s) at Week 16 Compared to Baseline
Time frame: Week 0 (baseline) to 16 weeks
The primary efficacy outcome of this study evaluates the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed for the purpose of this study.
Changes of saSPI (s) at Week 16 Compared to Baseline
Time frame: Week 0 (baseline) to 16 weeks
The primary efficacy objective of the study was to evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed. proSPI (s) score range is 0 to 50. Higher score means worse condition

9 secondary outcomes

PASI (Psoriasis Area Severity Index) Score
Time frame: week 0, 16, 52
Correlation Between PASI and proSPI (s)
Time frame: week 0, 16, 52
proSPI (s, p and i) Over Time
Time frame: weeks 0, 16, 52
saSPI (s, p and i) Over Time
Time frame: weeks 0, 16, 52
DLQI (Dermatology Life Quality Index) Over Time
Time frame: weeks 0, 16, 52
Self-administered PASI (SA-PASI)
Time frame: weeks 0, 16, 52
Psoriasis Symptom Diary (PSD) Score
Time frame: weeks 0, 16, 52
Correlation Between proSPI (for Each Component: s, p and i) and DLQI
Time frame: weeks 0, 16, 52
Correlation Between proSPI (for Components p and i) and PASI
Time frame: Over time (from Week 0 to Week 52)

Results and safety

Results posted to the registry on 17 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm Secukinumab	120	100

Primary outcome: proSPI (s) at Week 16 Compared to Baseline

Time frame: Week 0 (baseline) to 16 weeks. Mean (Standard Deviation). Unit: scores on a scale

Measure	Single Arm Secukinumab n = 119
W0	24.89 (10.747)
W16	2.34 (6.144)

Single Arm Secukinumab: Mean Difference (Net): -22.6 (95% CI -24.52 to 20.59), p <0.0001, t-test, 2 sided

Population analysed: The primary analysis was performed on the FAS. To assess for robustness of the results, the primary analysis was repeated for the FAS (on observed data).

Primary outcome: Changes of saSPI (s) at Week 16 Compared to Baseline

Time frame: Week 0 (baseline) to 16 weeks. Mean (Standard Deviation). Unit: scores on a scale

Measure	Single Arm Secukinumab n = 118
W0	23.54 (10.412)
W16	1.99 (4.508)

Single Arm Secukinumab: Mean Difference (Net): -21.6 (95% CI -23.52 to 19.58), p <0.0001, t-test, 2 sided

Population analysed: Full Analysis Set (FAS): The FAS comprised all patients from the IS who were administered at least one dose of investigational drug with at least one Baseline and one post-baseline SPI evaluation.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: baseline to 16 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AIN457 300mg	13 of 120 (10.8%)	86 of 120 (71.7%)	2 of 120

Limitations and caveats (from the sponsor): The two deaths (i.e.; head injury and lymphoma) were not related to the study treatment

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Related trials for Psoriasis

RecruitingPhase 3
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis: A Prospective Randomized Controlled Study.
Psoriasis, Psoriasis Genital
Enrolling by invitation
Combined High-Intensity Aerobic Training and Resistance Training in Psoriatic Arthritis
Psoriatic Arthritis
RecruitingPhase 2
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris

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.

PHILIPPE CELERIER principal investigator

HOPITAL SAINT LOUIS - LA ROCHELLE

MARIE-ALETH RICHARD principal investigator

HOPITAL TIMONES - MARSEILLE

SELIM ARACTINGI principal investigator

HOPITAL COCHIN - PARIS

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Secukinumab in people with Psoriasis, run by Novartis Pharmaceuticals at 17 sites in France.

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 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

proSPI (s) at Week 16 Compared to Baseline (time frame: Week 0 (baseline) to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02595970.

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 17 Apr 2019.