NCT01952015 is a Phase 3 clinical trial of Secukinumab in Psoriasis, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT01952015?

NCT01952015 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01952015?

Interventions in NCT01952015: Secukinumab.

Is NCT01952015 still recruiting?

NCT01952015 is currently completed. Last updated 15 March 2019.

Are results published for NCT01952015?

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

Last reviewed 2019-03-15 · How we verify

NCT01952015

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

Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)

Completed Phase 3 Results posted Last updated 15 March 2019

What this trial tests

Phase 3 trial testing Secukinumab in Psoriasis in 12 participants. Completed in 15 March 2016.

Timeline

21 August 2013

Primary endpoint
15 March 2016

15 March 2016

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	12
Start date	21 August 2013
Primary completion	15 March 2016
Estimated completion	15 March 2016
Sites	10 locations across Japan

Drugs / interventions tested

Secukinumab (secukinumab) — full drug profile →

Conditions studied

Psoriasis — all drugs for Psoriasis →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, 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.

Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) Primary · 16 weeks

Treatment success was defined as "Minimally improved", "Much improved" or "Very much improved" in Clinical global impression (CGI). Non-responder imputation assigns a value of nonresponse to missing data points, any patient who drops out is assumed to be a non-responder.

Treatment success - Yes

Group	Value	95% CI
AIN457	10

Treatment success - No

Group	Value	95% CI
AIN457	2

Very much improved

Group	Value	95% CI
AIN457	9

Much improved

Group	Value	95% CI
AIN457	1

Minimally improved

Group	Value	95% CI
AIN457	0

No change

Group	Value	95% CI
AIN457	1

Worse

Group	Value	95% CI
AIN457	0

Missing

Group	Value	95% CI
AIN457	1

Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) Secondary · 52 weeks

Ten patients showed treatment success at week 52 with clinical global impression (CGI) evaluated as "very much improved", "much improved", "minimally improved". Two patients did not achieve treatment success at week 52 with CGI evaluated as "missing" and both were imputed as "no treatment success".

Treatment success - Yes

Group	Value	95% CI
AIN457	10

Treatment success - No

Group	Value	95% CI
AIN457	2

CGI - very much improved

Group	Value	95% CI
AIN457	7

CGI - much improved

Group	Value	95% CI
AIN457	2

CGI - minimally improved

Group	Value	95% CI
AIN457	1

CGI - No change

Group	Value	95% CI
AIN457	0

CGI - worse

Group	Value	95% CI
AIN457	2

Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set) Secondary · week 148

Clinical global impression (CGI) evaluated as "very much improved", "much improved", "Minimally improved".

Very much improved

Group	Value	95% CI
AIN457	8

Much improved

Group	Value	95% CI
AIN457	1

Minimally improved

Group	Value	95% CI
AIN457	0

No change

Group	Value	95% CI
AIN457	0

Worse

Group	Value	95% CI
AIN457	0

Missing

Group	Value	95% CI
AIN457	0

Summary of Clinical Global Impression up to End of Trial Secondary · up to week 148 (End of Trial)

Clinical Global Impression (CGI) has five categories: Very much improved, much improved, minimally improved, no change and worsened. Two patients did not achieve treatment success at week 52 with CGI evaluated as missing and both were imputed as "no treatment success".

Week 1

Group	Value	95% CI
Very Much Improved	4
Much Improved	5
Minimally Improved	1
No Change	1
Worse	0
Missing	0

Week 2

Group	Value	95% CI
Very Much Improved	7
Much Improved	4
Minimally Improved	0
No Change	0
Worse	0
Missing	0

Week 3

Group	Value	95% CI
Very Much Improved	10
Much Improved	1
Minimally Improved	0
No Change	0
Worse	0
Missing	0

Week 4

Group	Value	95% CI
Very Much Improved	10
Much Improved	2
Minimally Improved	0
No Change	0
Worse	0
Missing	0

Week 8

Group	Value	95% CI
Very Much Improved	9
Much Improved	2
Minimally Improved	0
No Change	1
Worse	0
Missing	0

Week 16

Group	Value	95% CI
Very Much Improved	9
Much Improved	1
Minimally Improved	0
No Change	1
Worse	0
Missing	0

Week 24

Group	Value	95% CI
Very Much Improved	8
Much Improved	1
Minimally Improved	1
No Change	0
Worse	1
Missing	0

Week 36

Group	Value	95% CI
Very Much Improved	7
Much Improved	3
Minimally Improved	0
No Change	1
Worse	0
Missing	0

Summary of JDA Total Score Category for GPP by Visit up to End of Trial Secondary · up to week 148 (End of Trial)

Japanese dermatological association (JDA) severity index for generalized pustular psoriasis (GPP) included 3 categories (mild, moderate, and severe) in the severity index.

Baseline

Group	Value	95% CI
None	0
Mild	9
Moderate	3
Severe	0
Missing	0

Week 1

Group	Value	95% CI
None	0
Mild	10
Moderate	1
Severe	0
Missing	0

Week 2

Group	Value	95% CI
None	0
Mild	11
Moderate	0
Severe	0
Missing	0

Week 3

Group	Value	95% CI
None	0
Mild	11
Moderate	0
Severe	0
Missing	0

Week 4

Group	Value	95% CI
None	1
Mild	11
Moderate	0
Severe	0
Missing	0

Week 8

Group	Value	95% CI
None	0
Mild	12
Moderate	0
Severe	0
Missing	0

Week 16

Group	Value	95% CI
None	0
Mild	11
Moderate	0
Severe	0
Missing	0

Week 24

Group	Value	95% CI
None	1
Mild	9
Moderate	1
Severe	0
Missing	0

The Japanese Dermatological Association (JDA) Component Score for GPP Over Time Secondary · up to week 148 (end of trial)

The following components of the JDA severity index for generalized pustular psoriasis (GPP) were reported: body surface area (SA)covered with total erythema with pustules, body SA covered with total erythema, body SA covered with edema, fever, white blood cell (WBC) count, C-reactive protein, serum albumin. The total score of JDA severity index was assigned a score of 0-17. Assessment of skin lesions: area of erythema with pustules, area of erythema, and area of edema; each score 0-3. Assessment of systemic manifestations and laboratory findings: fever, WBC count, CRP and serum albumin; each

Body SA w/ erythema with pustules - Baseline

Group	Value	95% CI
AIN457	2	± 0.00

Body SA w/ erythema with pustules - Week 24

Group	Value	95% CI
AIN457	0.3	± 0.65

Body SA w/ erythema with pustules - Week 52

Group	Value	95% CI
AIN457	0.0	± 0.00

Body SA w/ erythema w/ pustules - End of Treatment

Group	Value	95% CI
AIN457	0.0	± 0.00

Body SA w/ total erythema - Baseline

Group	Value	95% CI
AIN457	1.6	± 0.67

Body SA w/ total erythema - Week 24

Group	Value	95% CI
AIN457	1.1	± 0.54

Body SA w/ total erythema - Week 52

Group	Value	95% CI
AIN457	0.8	± 0.42

Body SA w/ total erythema - End of Treatment

Group	Value	95% CI
AIN457	0.7	± 0.50

Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP Secondary · up to week 148 (end of trial)

The observed value for the following components of the JDA severity index for GPP were reported: percentage of body surface area covered with erythema with pustules, percentage of body surface area covered with total erythema, percentage of body surface area covered with edema, fever (body temperature,°C), white blood cell (WBC) count (/μL), C-reactive protein (mg/L), serum albumin (g/dL). Percent change=100 x Absolute change/post baseline.

Area of erythema with pustules (Week 24)

Group	Value	95% CI
AIN457	-89.09	± 33.001

Area of erythema with pustules (Week 52)

Group	Value	95% CI
AIN457	-100.00	± 0.000

Area of erythema with pustules (Week 148)

Group	Value	95% CI
AIN457	-100.00	± 0.000

Area of Erythema (Week 24)

Group	Value	95% CI
AIN457	-63.56	± 46.693

Area of Erythema (Week 52)

Group	Value	95% CI
AIN457	-83.60	± 24.442

Area of Erythema (Week 148)

Group	Value	95% CI
AIN457	-87.01	± 15.826

Area of Edema (Week 24)

Group	Value	95% CI
AIN457	-47.92	± 107.200

Area of Edema (Week 52)

Group	Value	95% CI
AIN457	-69.17	± 69.733

Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time Secondary · Up to week 148 (end of treatment)

DLQI is a 10-item general dermatology disability index designed to assess HRQL in adults with skin diseases (Finlay \& Khan 94). The measure is self-admin. \& includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. DLQI total score is the sum of the 10 questions. Each item has four response categories, ranging from 0 (not at all) to 3 (very much). Scores range from 0 to 30 9higher scores indicate greater health-related quality of-life impairment). SF-36 is a widely used and extensively studied instrument to measure HRQL among he

DLQI total score at Baseline

Group	Value	95% CI
AIN457	8.4	± 6.88

DLQI total score at Week 24

Group	Value	95% CI
AIN457	4.5	± 5.16

DLQI total score at Week 52

Group	Value	95% CI
AIN457	2.7	± 2.41

DLQI total score at end of treatment

Group	Value	95% CI
AIN457	4.7	± 8.25

SF-36 - MCS at Baseline

Group	Value	95% CI
AIN457	43.69	± 17.472

SF-36 - MCS at Week 24

Group	Value	95% CI
AIN457	46.70	± 9.9696

SF-36 - MCS at Week 52

Group	Value	95% CI
AIN457	46.27	± 11.768

SF-36 - MCS at end of trial

Group	Value	95% CI
AIN457	47.70	± 13.457

Number of Patients With GPP-related Systemic and Topical Co-medication Over Time Secondary · up to week 52

Use of systemic and topical co-medication to treat generalized pustular psoriasis (GPP), in subjects who have active GPP treatment at baseline.

Topical co-medication related to GPP

Group	Value	95% CI
AIN457	12

Systemic co-medication related to GPP

Group	Value	95% CI
AIN457	8

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events are collected from first patient first visit (FPFV) until last patient last visit (LPLV). All adverse events reported in this record are from the late of first patient first treatment until last patient last visit, approximately 3 years.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AIN457

Serious: 3/12 (25%)

Deaths: —

Serious adverse events (7 terms)

Reaction	System	AIN457
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	—
DRUG-INDUCED LIVER INJURY	Hepatobiliary disorders	—
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	—
CELLULITIS	Infections and infestations	—
ERYSIPELAS	Infections and infestations	—
HYPOGLYCAEMIA	Metabolism and nutrition disorders	—
BOWEN'S DISEASE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—

Other adverse events (59 terms — click to expand)

Reaction	System	AIN457
NASOPHARYNGITIS	Infections and infestations	—
DIABETES MELLITUS	Metabolism and nutrition disorders	—
ARTHRALGIA	Musculoskeletal and connective tissue disorders	—
URTICARIA	Skin and subcutaneous tissue disorders	—
ANAEMIA	Blood and lymphatic system disorders	—
ARRHYTHMIA SUPRAVENTRICULAR	Cardiac disorders	—
SINUS TACHYCARDIA	Cardiac disorders	—
CATARACT	Eye disorders	—
CONJUNCTIVAL HAEMORRHAGE	Eye disorders	—
CONJUNCTIVITIS ALLERGIC	Eye disorders	—
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	—
DUODENITIS	Gastrointestinal disorders	—
GASTRIC ULCER	Gastrointestinal disorders	—
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	—
HAEMORRHOIDS	Gastrointestinal disorders	—
LARGE INTESTINE POLYP	Gastrointestinal disorders	—
PYREXIA	General disorders	—
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	—
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	—
CELLULITIS	Infections and infestations	—
ECZEMA IMPETIGINOUS	Infections and infestations	—
ERYTHRASMA	Infections and infestations	—
FOLLICULITIS	Infections and infestations	—
GENITAL CANDIDIASIS	Infections and infestations	—
HELICOBACTER INFECTION	Infections and infestations	—
IMPETIGO	Infections and infestations	—
OTITIS EXTERNA	Infections and infestations	—
PARONYCHIA	Infections and infestations	—
PHARYNGITIS	Infections and infestations	—
SINUSITIS	Infections and infestations	—
STREPTOCOCCAL INFECTION	Infections and infestations	—
URINARY TRACT INFECTION	Infections and infestations	—
FALL	Injury, poisoning and procedural complications	—
RIB FRACTURE	Injury, poisoning and procedural complications	—
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	—
C-REACTIVE PROTEIN INCREASED	Investigations	—
WEIGHT DECREASED	Investigations	—
HYPOVOLAEMIA	Metabolism and nutrition disorders	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—
LUMBAR SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: UPPER GASTROINTESTINAL HAEMORRHAGE, DRUG-INDUCED LIVER INJURY, HEPATIC FUNCTION ABNORMAL, CELLULITIS, ERYSIPELAS, HYPOGLYCAEMIA, BOWEN'S DISEASE.

Data from ClinicalTrials.gov NCT01952015 adverse events section.

Sponsor's own description

The purpose of this study was to assess efficacy and safety data of secukinumab in Japanese subjects with generalized pustular psoriasis (GPP). This study was expected to support the filing of secukinumab in the indication of pustular psoriasis in Japan.

Publications & conference data

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

Pustular Psoriasis: From Pathophysiology to Treatment.
Genovese G, Moltrasio C, Cassano N, Maronese CA, et al · · 2021 · cited 40× · PMID 34944562 · DOI 10.3390/biomedicines9121746
Current Treatments for Generalized Pustular Psoriasis: A Narrative Summary of a Systematic Literature Search.
Puig L, Fujita H, Thaçi D, Zheng M, et al · · 2024 · cited 8× · PMID 39088126 · DOI 10.1007/s13555-024-01230-z
Considerations for Treating Generalized Pustular Psoriasis (GPP): A Narrative Review.
Lynde CW, Prajapati VH, Gooderham MJ, Hong HC, et al · · 2025 · PMID 41066059 · DOI 10.1007/s13555-025-01535-7

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 NCT01952015 (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: 15 March 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/NCT01952015.

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