NCT03066609

Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

Completed Phase 3 Results posted Last updated 30 December 2019

What this trial tests

Phase 3 trial testing Secukinumab 150 mg s.c. in Plaque Psoriasis in 543 participants. Completed in 20 November 2018.

Timeline

28 February 2017

Primary endpoint
21 December 2017

20 November 2018

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	543
Start date	28 February 2017
Primary completion	21 December 2017
Estimated completion	20 November 2018
Sites	32 locations across Malaysia, Hungary, Philippines, Thailand, China, Turkey (Türkiye)

Drugs / interventions tested

• Secukinumab 150 mg s.c. — full drug profile →
• Secukinumab 300 mg s.c. — full drug profile →
• Placebo

Conditions studied

• Plaque Psoriasis — all drugs for Plaque Psoriasis →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Plaque 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.

Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) Primary · Week 12

Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale

Group	Value	95% CI
Secukinumab 150mg	112
Secukinumab 300mg	254
Placebo	6

Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation) Primary · Week 12

Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achie

Group	Value	95% CI
Secukinumab 150mg	92
Secukinumab 300mg	214
Placebo	4

Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation) Secondary · Week 12

Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale

Group	Value	95% CI
Secukinumab 150mg	85
Secukinumab 300mg	210
Placebo	2

Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation) Secondary · Week 52

Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale

Group	Value	95% CI
Secukinumab 150mg	94
Secukinumab 300mg	235

Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation) Secondary · Week 52

Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achie

Group	Value	95% CI
Secukinumab 150mg	65
Secukinumab 300mg	162

PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) Secondary · week 1, week 12, week 24, week 52

Number (%) of subjects with PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0 or 1 response

Week 1 IGA 0/1

Group	Value	95% CI
Secukinumab 150mg	0
Secukinumab 300mg	1
Placebo	0
Placebo - AIN457 300 mg	0

Week 1 PASI 50

Group	Value	95% CI
Secukinumab 150mg	5
Secukinumab 300mg	25
Placebo	1
Placebo - AIN457 300 mg	0

Week 1 PASI 75

Group	Value	95% CI
Secukinumab 150mg	0
Secukinumab 300mg	0
Placebo	0
Placebo - AIN457 300 mg	0

Week 1 PASI 90

Group	Value	95% CI
Secukinumab 150mg	0
Secukinumab 300mg	0
Placebo	0
Placebo - AIN457 300 mg	0

Week 1 PASI 100

Group	Value	95% CI
Secukinumab 150mg	0
Secukinumab 300mg	0
Placebo	0
Placebo - AIN457 300 mg	0

Week 12 IGA 0/1

Group	Value	95% CI
Secukinumab 150mg	92
Secukinumab 300mg	214
Placebo	4
Placebo - AIN457 300 mg	0

Week 12 PASI 50

Group	Value	95% CI
Secukinumab 150mg	130
Secukinumab 300mg	267
Placebo	16
Placebo - AIN457 300 mg	0

Week 12 PASI 75

Group	Value	95% CI
Secukinumab 150mg	112
Secukinumab 300mg	254
Placebo	6
Placebo - AIN457 300 mg	0

American Collage of Rheumatology (ACR) Response 20/50/70 Secondary · week 12, week 24, week 52

Percentage of patients who achieved ACR 20/50/70 at Week 12 and up to Week 52. The subset of patients who had active PsA at baseline included 7 patients in the secukinumab 150 mg group, 17 patients in the secukinumab 300 mg group and 4 patients in the placebo group. ACR 20, 50 or 70 responses correspond, respectively, to at least 20%, 50% or 70% improvement in comparison with baseline in the number of tender and swollen joint counts, in addition to similar improvements in at least three of five other measure of disability or disease activity

Week 12 ACR 20

Group	Value	95% CI
Secukinumab 150mg	4
Secukinumab 300mg	13
Placebo	0
Placebo - AIN457 300 mg	0

Week 12 ACR 50

Group	Value	95% CI
Secukinumab 150mg	3
Secukinumab 300mg	12
Placebo	0
Placebo - AIN457 300 mg	0

Week 12 ACR 70

Group	Value	95% CI
Secukinumab 150mg	2
Secukinumab 300mg	6
Placebo	0
Placebo - AIN457 300 mg	0

Week 24 ACR 20

Group	Value	95% CI
Secukinumab 150mg	5
Secukinumab 300mg	14
Placebo	0
Placebo - AIN457 300 mg	2

Week 24 ACR 50

Group	Value	95% CI
Secukinumab 150mg	4
Secukinumab 300mg	10
Placebo	0
Placebo - AIN457 300 mg	1

Week 24 ACR 70

Group	Value	95% CI
Secukinumab 150mg	2
Secukinumab 300mg	6
Placebo	0
Placebo - AIN457 300 mg	1

Week 52 ACR 20

Group	Value	95% CI
Secukinumab 150mg	4
Secukinumab 300mg	13
Placebo	0
Placebo - AIN457 300 mg	3

Week 52 ACR 50

Group	Value	95% CI
Secukinumab 150mg	3
Secukinumab 300mg	11
Placebo	0
Placebo - AIN457 300 mg	2

Time to PASI 75 Response up to Week 12 Secondary · week 12

Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale

Group	Value	95% CI
Secukinumab 150mg	57	51 – 57
Secukinumab 300mg	55	29 – 57

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AIN457 150 mg

Serious: 5/136 (4%)

Deaths: 0/136

AIN457 300 mg

Serious: 9/272 (3%)

Deaths: 0/272

Any AIN457 300 mg

Serious: 14/401 (3%)

Deaths: 0/401

Any AIN457 Dose

Serious: 19/537 (4%)

Deaths: 0/537

Placebo

Serious: 2/135 (1%)

Deaths: 0/135

Serious adverse events (32 terms)

Reaction	System	AIN457 150 mg	AIN457 300 mg	Any AIN457 300 mg	Any AIN457 Dose	Placebo
Arteriosclerosis coronary artery	Cardiac disorders	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—
Angina unstable	Cardiac disorders	—	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—	—
Diabetic retinopathy	Eye disorders	—	—	—	—	—
Crohn's disease	Gastrointestinal disorders	—	—	—	—	—
Enteritis	Gastrointestinal disorders	—	—	—	—	—
Haemorrhoids	Gastrointestinal disorders	—	—	—	—	—
Mouth ulceration	Gastrointestinal disorders	—	—	—	—	—
Tooth impacted	Gastrointestinal disorders	—	—	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—	—	—
Hepatic mass	Hepatobiliary disorders	—	—	—	—	—
Hepatic steatosis	Hepatobiliary disorders	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—
Erysipelas	Infections and infestations	—	—	—	—	—
Peritonitis	Infections and infestations	—	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—	—
Comminuted fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Forearm fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Tibia fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Cerebral infarction	Nervous system disorders	—	—	—	—	—
Diabetic neuropathy	Nervous system disorders	—	—	—	—	—

Other adverse events (26 terms — click to expand)

Reaction	System	AIN457 150 mg	AIN457 300 mg	Any AIN457 300 mg	Any AIN457 Dose	Placebo
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—	—
Hyperlipidaemia	Metabolism and nutrition disorders	—	—	—	—	—
Folliculitis	Infections and infestations	—	—	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—	—	—
Tinea pedis	Infections and infestations	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—	—
C-reactive protein increased	Investigations	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Blood uric acid increased	Investigations	—	—	—	—	—
Psoriasis	Skin and subcutaneous tissue disorders	—	—	—	—	—
Dyslipidaemia	Metabolism and nutrition disorders	—	—	—	—	—

Most-reported serious reactions: Arteriosclerosis coronary artery, Appendicitis, Angina unstable, Coronary artery disease, Diabetic retinopathy, Crohn's disease, Enteritis, Haemorrhoids.

Data from ClinicalTrials.gov NCT03066609 adverse events section.

Sponsor's own description

The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis

Publications & conference data

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

1. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Garcia-Doval I, Doney L, et al · · 2022 · cited 84× · PMID 35603936 · DOI 10.1002/14651858.cd011535.pub5
2. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Afach S, Doney L, et al · · 2020 · cited 78× · PMID 31917873 · DOI 10.1002/14651858.cd011535.pub3
3. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Guelimi R, Garcia-Doval I, et al · · 2023 · cited 67× · PMID 37436070 · DOI 10.1002/14651858.cd011535.pub6
4. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Garcia-Doval I, Doney L, et al · · 2021 · cited 54× · PMID 33871055 · DOI 10.1002/14651858.cd011535.pub4
5. Comparative Efficacy and Relative Ranking of Biologics and Oral Therapies for Moderate-to-Severe Plaque Psoriasis: A Network Meta-analysis.
   Armstrong AW, Soliman AM, Betts KA, Wang Y, et al · · 2021 · cited 46× · PMID 33788177 · DOI 10.1007/s13555-021-00511-1
6. Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis.
   Cai L, Zhang JZ, Yao X, Gu J, et al · · 2020 · cited 38× · PMID 33060370 · DOI 10.1097/cm9.0000000000001163
7. Understanding efficacy-safety balance of biologics in moderate-to-severe pediatric psoriasis.
   Golhen K, Winskill C, Theiler M, Buettcher M, et al · · 2022 · cited 6× · PMID 36226155 · DOI 10.3389/fmed.2022.944208
8. Systematic Review and Meta-Analysis of Inflammatory Bowel Disease Adverse Events with Anti-Interleukin 17A Agents and Tumor Necrosis Factor Inhibitors in Rheumatic Disease and Skin Psoriasis.
   Truong SL, Chin J, Liew DFL, Zahir SF, et al · · 2021 · cited 6× · PMID 34449067 · DOI 10.1007/s40744-021-00360-6