NCT02595970 (IPSI-PSO) is a Phase 3 clinical trial of Secukinumab in Psoriasis, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT02595970?

NCT02595970 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT02595970?

Interventions in NCT02595970: Secukinumab.

Is NCT02595970 still recruiting?

NCT02595970 is currently completed. Last updated 17 April 2019.

Are results published for NCT02595970?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-04-17 · How we verify

NCT02595970: IPSI-PSO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 17 April 2019

What this trial tests

Phase 3 trial testing Secukinumab in Psoriasis in 120 participants. Completed in 9 February 2017.

Timeline

20 May 2015

Primary endpoint
9 February 2017

9 February 2017

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	20 May 2015
Primary completion	9 February 2017
Estimated completion	9 February 2017
Sites	17 locations across France

Drugs / interventions tested

Secukinumab (secukinumab) — full drug profile →

Conditions studied

Psoriasis — all drugs for Psoriasis →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 70, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

proSPI (s) at Week 16 Compared to Baseline Primary · 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.

Group	Value	95% CI
Single Arm Secukinumab	24.89	± 10.747

W16

Group	Value	95% CI
Single Arm Secukinumab	2.34	± 6.144

PASI (Psoriasis Area Severity Index) Score Secondary · week 0, 16, 52

PASI administered by a professional score range: 0 (no disease) to 72 (maximal disease)

Group	Value	95% CI
Single Arm Secukinumab	23.09	± 10.541

W16

Group	Value	95% CI
Single Arm Secukinumab	2.23	± 3.927

W52

Group	Value	95% CI
Single Arm Secukinumab	3.16	± 5.427

Correlation Between PASI and proSPI (s) Secondary · week 0, 16, 52

Psoriasis Area Severity Index vs Professional Version of Simplified Psoraisis Index (proSPI) score

Group	Value	95% CI
Single Arm Secukinumab	0.691	0.58 – 0.78

W16

Group	Value	95% CI
Single Arm Secukinumab	0.814	0.74 – 0.87

W52

Group	Value	95% CI
Single Arm Secukinumab	0.927	0.89 – 0.95

proSPI (s, p and i) Over Time Secondary · weeks 0, 16, 52

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

proSPI (s) - W0

Group	Value	95% CI
Single Arm Secukinumab	24.89	± 10.747

proSPI (s) - W16

Group	Value	95% CI
Single Arm Secukinumab	1.83	± 4.427

proSPI (s) - W52

Group	Value	95% CI
Single Arm Secukinumab	2.93	± 6.557

proSPI (p) - W0

Group	Value	95% CI
Single Arm Secukinumab	7.80	± 1.885

proSPI (p) - W16

Group	Value	95% CI
Single Arm Secukinumab	1.34	± 2.201

proSPI (p) - W52

Group	Value	95% CI
Single Arm Secukinumab	1.59	± 2.341

proSPI (i) - W0

Group	Value	95% CI
Single Arm Secukinumab	4.26	± 1.924

proSPI (i) - W16

Group	Value	95% CI
Single Arm Secukinumab	4.78	± 1.633

saSPI (s, p and i) Over Time Secondary · weeks 0, 16, 52

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

saSPI(s) - W0

Group	Value	95% CI
Single Arm Secukinumab	23.54	± 10.412

saSPI(s) - W16

Group	Value	95% CI
Single Arm Secukinumab	1.80	± 4.319

saSPI(s) - W52

Group	Value	95% CI
Single Arm Secukinumab	2.15	± 4.229

saSPI(p) - W0

Group	Value	95% CI
Single Arm Secukinumab	8.18	± 1.855

saSPI(p) - W16

Group	Value	95% CI
Single Arm Secukinumab	1.54	± 2.299

saSPI(p) - W52

Group	Value	95% CI
Single Arm Secukinumab	1.47	± 2.126

saSPI(i) - W0

Group	Value	95% CI
Single Arm Secukinumab	4.34	± 1.940

saSPI(i) - W16

Group	Value	95% CI
Single Arm Secukinumab	4.39	± 2.221

DLQI (Dermatology Life Quality Index) Over Time Secondary · weeks 0, 16, 52

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

Group	Value	95% CI
Single Arm Secukinumab	13.6	± 7.44

W16

Group	Value	95% CI
Single Arm Secukinumab	2.1	± 3.67

W52

Group	Value	95% CI
Single Arm Secukinumab	1.9	± 3.37

Self-administered PASI (SA-PASI) Secondary · weeks 0, 16, 52

self-administered PASI (SA-PASI) score

Group	Value	95% CI
Single Arm Secukinumab	25.8	± 13.55

W16

Group	Value	95% CI
Single Arm Secukinumab	2.6	± 6.66

W52

Group	Value	95% CI
Single Arm Secukinumab	3.3	± 7.10

Psoriasis Symptom Diary (PSD) Score Secondary · weeks 0, 16, 52

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

Intensity of pain recorded in PSD- W0

Group	Value	95% CI
Single Arm Secukinumab	5.2	± 3.18

Intensity of pain recorded in PSD - W16

Group	Value	95% CI
Single Arm Secukinumab	0.9	± 2.00

Intensity of pain recorded in PSD - W52

Group	Value	95% CI
Single Arm Secukinumab	0.9	± 1.78

Intensity of itching recorded in PSD - W0

Group	Value	95% CI
Single Arm Secukinumab	6.7	± 2.85

Intensity of itching recorded in PSD - W16

Group	Value	95% CI
Single Arm Secukinumab	1.3	± 2.21

Intensity of itching recorded in PSD - W52

Group	Value	95% CI
Single Arm Secukinumab	1.4	± 2.11

Intensity of scaling recorded in PSD - W0

Group	Value	95% CI
Single Arm Secukinumab	6.5	± 2.70

Intensity of scaling recorded in PSD - W16

Group	Value	95% CI
Single Arm Secukinumab	1.0	± 1.96

Correlation Between proSPI (for Each Component: s, p and i) and DLQI Secondary · weeks 0, 16, 52

Correlation between proSPI (for each component: s, p and i) and DLQI is summarized in table below

proSPI (s) and DLQI - W0

Group	Value	95% CI
Single Arm Secukinumab	0.224	0.04 – 0.39

proSPI (s) and DLQI - W16

Group	Value	95% CI
Single Arm Secukinumab	0.418	0.25 – 0.56

proSPI (s) and DLQI - W52

Group	Value	95% CI
Single Arm Secukinumab	0.514	0.34 – 0.65

proSPI (p) and DLQI - W0

Group	Value	95% CI
Single Arm Secukinumab	0.494	0.34 – 0.62

proSPI (p) and DLQI - W16

Group	Value	95% CI
Single Arm Secukinumab	0.671	0.55 – 0.76

proSPI (p) and DLQI - W52

Group	Value	95% CI
Single Arm Secukinumab	0.757	0.65 – 0.83

proSPI (i) and DLQI - W0

Group	Value	95% CI
Single Arm Secukinumab	0.102	-0.08 – 0.28

proSPI (i) and DLQI - W16

Group	Value	95% CI
Single Arm Secukinumab	0.016	-0.17 – 0.20

Correlation Between proSPI (for Components p and i) and PASI Secondary · Over time (from Week 0 to Week 52)

Correlation between proSPI (p, i) and PASI score by visit (Full Analysis Set (observed)) is summarized in table below

proSPI (p) and PASI - W0

Group	Value	95% CI
Single Arm Secukinumab	0.173	-0.01 – 0.34

proSPI (p) and PASI - W16

Group	Value	95% CI
Single Arm Secukinumab	0.678	0.56 – 0.77

proSPI (p) and PASI - W52

Group	Value	95% CI
Single Arm Secukinumab	0.749	0.64 – 0.83

proSPI (i) and PASI - W0

Group	Value	95% CI
Single Arm Secukinumab	0.014	-0.17 – 0.19

proSPI (i) and PASI - W16

Group	Value	95% CI
Single Arm Secukinumab	0.105	-0.08 – 0.29

proSPI (i) and PASI - W52

Group	Value	95% CI
Single Arm Secukinumab	0.172	-0.04 – 0.36

Changes of saSPI (s) at Week 16 Compared to Baseline Primary · 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. H

Group	Value	95% CI
Single Arm Secukinumab	23.54	± 10.412

W16

Group	Value	95% CI
Single Arm Secukinumab	1.99	± 4.508

Adverse events — posted to ClinicalTrials.gov

Time frame: baseline to 16 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AIN457 300mg

Serious: 13/120 (11%)

Deaths: 2/120

Serious adverse events (18 terms)

Reaction	System	AIN457 300mg
Coronary artery occlusion	Cardiac disorders	—
Punctate keratitis	Eye disorders	—
Stomatitis	Gastrointestinal disorders	—
Strangulated umbilical hernia	Gastrointestinal disorders	—
Face oedema	General disorders	—
Head injury	Injury, poisoning and procedural complications	—
Meniscus injury	Injury, poisoning and procedural complications	—
Tendon rupture	Injury, poisoning and procedural complications	—
Diabetes mellitus	Metabolism and nutrition disorders	—
Hypoglycaemia	Metabolism and nutrition disorders	—
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Mycosis fungoides	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Cerebral ischaemia	Nervous system disorders	—
Cerebrovascular accident	Nervous system disorders	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	—
Ecchymosis	Skin and subcutaneous tissue disorders	—

Other adverse events (13 terms — click to expand)

Reaction	System	AIN457 300mg
Nasopharyngitis	Infections and infestations	—
Back pain	Musculoskeletal and connective tissue disorders	—
Diarrhoea	Gastrointestinal disorders	—
Bronchitis	Infections and infestations	—
Rhinitis	Infections and infestations	—
Psoriasis	Skin and subcutaneous tissue disorders	—
Asthenia	General disorders	—
Influenza	Infections and infestations	—
Headache	Nervous system disorders	—
Hypertension	Vascular disorders	—
Viral upper respiratory tract infection	Infections and infestations	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Coronary artery occlusion, Punctate keratitis, Stomatitis, Strangulated umbilical hernia, Face oedema, Head injury, Meniscus injury, Tendon rupture.

Data from ClinicalTrials.gov NCT02595970 adverse events section.

Sponsor's own description

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 psoriasis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Association of Secukinumab Treatment With Tuberculosis Reactivation in Patients With Psoriasis, Psoriatic Arthritis, or Ankylosing Spondylitis.
Elewski BE, Baddley JW, Deodhar AA, Magrey M, et al · · 2021 · cited 51× · PMID 33001147 · DOI 10.1001/jamadermatol.2020.3257
Secukinumab efficacy in reducing the severity and the psychosocial impact of moderate-to-severe psoriasis as assessed by the Simplified Psoriasis Index: results from the IPSI-PSO study.
Richard MA, Lacour JP, Konstantinou MP, Ruer-Mulard M, et al · · 2021 · cited 5× · PMID 32815591 · DOI 10.1111/jdv.16893

Verify or expand the search:

Other trials of Secukinumab

Trials testing the same drug.

NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07477795 — Phase II Interventional Study Evaluating Efficacy and Safety of Secukinumab in Active Severe Takayasu Patients · Phase 2 · not yet recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
NCT07243782 — Regulatory Post-Marketing Surveillance in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cose · recruiting
NCT06751238 — Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in · Phase 1 · recruiting

Other recruiting trials for Psoriasis

Currently open trials in the same condition.

NCT07471048 — A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoria · NA · recruiting
NCT07449234 — A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis · recruiting
NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO) · recruiting
NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial · Phase 2 · recruiting
NCT07250997 — PALLAS Laser for Skin Diseases · NA · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02595970 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 17 April 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02595970.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing