Study to demonstrate the efficacy, safety and tolerability of intravenous secukinumab up to 52 weeks in subjects with active Psoriatic Arthritis

A randomized, double-blind, placebo-controlled, parallel group, phase III multicenter study of intravenous secukinumab to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Psoriatic Arthritis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001176-11-GR

Enrollment

380

Registered

2020-01-03

Start date

2020-02-28

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Interventions

Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Secukinumab CAS Number: 1229022-83-6 Current Sponsor code: AIN457 Other d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosed with PsA by CASPAR criteria with symptoms for at least 6 months and moderate to severe PsA having at least 3 tender joints out of 8 and at least 3 swollen joints out of 76 - Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis - Inadequate response to NSDAIDs Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 342 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38

Exclusion criteria

Exclusion criteria: - Pregnancy or lactation - Ongoing infectious or malignant process on a chest X-ray or MRI - Previous exposure to IL-17 or IL-17R targeting therapies - Previous exposure to any biological immunomodulating agent excluding TNF antagonists Other protocol-defined exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that the efficacy of i.v. secukinumab at Week 16 is superior to placebo in subjects with active psoriatic arthritis (PsA) based on the proportion of patients achieving an American College of Rheumatology 50 (ACR50) response.;Secondary Objective: -To demonstrate that the efficacy of i.v. secukinumab at Week 16 is superior to placebo based on: the proportion of subjects achieving: 1- an ACR20 response 2- minimal disease activity (MDA) 5/7 3- a PASI90 response in the group of subjects who have >=3% skin involvement with psoriasis. the improvement from baseline for the: 4- PASDAS 5- HAQ-DI 6- SF36-PCS 7- FACIT-fatigue 8- mNAPSI the proportion of subjects with resolution of: 9- dactylitis by the Leeds Dactylitis Index in the subset of subjects who have dactylitis at baseline 10- enthesitis by the Leeds Enthesitis Index in the subset of subjects who have enthesitis at baseline 11- Overall safety and tolerability of secukinumab compared to placebo as assessed by vital signs, clinical laboratory values and adverse events monitoring;Primary end point(s): American College of Rheumatology 50 (ACR50) response;Timepoint(s) of evaluation of this end point: 16 weeks	—

Measure

Time frame

Main Objective: To demonstrate that the efficacy of i.v. secukinumab at Week 16 is superior to placebo in subjects with active psoriatic arthritis (PsA) based on the proportion of patients achieving an American College of Rheumatology 50 (ACR50) response.;Secondary Objective: -To demonstrate that the efficacy of i.v. secukinumab at Week 16 is superior to placebo based on: the proportion of subjects achieving: 1- an ACR20 response 2- minimal disease activity (MDA) 5/7 3- a PASI90 response in the group of subjects who have >=3% skin involvement with psoriasis. the improvement from baseline for the: 4- PASDAS 5- HAQ-DI 6- SF36-PCS 7- FACIT-fatigue 8- mNAPSI the proportion of subjects with resolution of: 9- dactylitis by the Leeds Dactylitis Index in the subset of subjects who have dactylitis at baseline 10- enthesitis by the Leeds Enthesitis Index in the subset of subjects who have enthesitis at baseline 11- Overall safety and tolerability of secukinumab compared to placebo as assessed by vital signs, clinical laboratory values and adverse events monitoring;Primary end point(s): American College of Rheumatology 50 (ACR50) response;Timepoint(s) of evaluation of this end point: 16 weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1- an ACR20 response 2- minimal disease activity (MDA) 5/7 3- a PASI90 response in the group of subjects who have >=3% skin involvement with psoriasis. 4- PASDAS 5- HAQ-DI 6- SF36-PCS 7- FACIT-fatigue 8- mNAPSI 9- dactylitis by the Leeds Dactylitis Index in the subset of subjects who have dactylitis at baseline 10- enthesitis by the Leeds Enthesitis Index in the subset of subjects who have enthesitis at baseline 11- Overall safety and tolerability of secukinumab compared to placebo as assessed by vital signs, clinical laboratory values and adverse events monitoring;Timepoint(s) of evaluation of this end point: 1 to 4: 16 weeks 4 to 8: Baseline to Week 16 9 and 10: 16 weeks 11: 60 weeks	—

Measure

Time frame

Secondary end point(s): 1- an ACR20 response 2- minimal disease activity (MDA) 5/7 3- a PASI90 response in the group of subjects who have >=3% skin involvement with psoriasis. 4- PASDAS 5- HAQ-DI 6- SF36-PCS 7- FACIT-fatigue 8- mNAPSI 9- dactylitis by the Leeds Dactylitis Index in the subset of subjects who have dactylitis at baseline 10- enthesitis by the Leeds Enthesitis Index in the subset of subjects who have enthesitis at baseline 11- Overall safety and tolerability of secukinumab compared to placebo as assessed by vital signs, clinical laboratory values and adverse events monitoring;Timepoint(s) of evaluation of this end point: 1 to 4: 16 weeks 4 to 8: Baseline to Week 16 9 and 10: 16 weeks 11: 60 weeks

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Countries

Brazil, Bulgaria, Colombia, Czech Republic, Greece, Guatemala, India, Malaysia, Philippines, Poland, Russian Federation, South Africa, Thailand, Turkey, United States

Contacts

Public ContactVeronique Schaaf

Novartis (Hellas) S.A.C.I.

veronique.schaaf@novartis.com+302102897152

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026