Efficacy of secukinumab compared to adalimumab in patients with psoriatic arthritis

A randomized, double-blind, active control, multicenter study to evaluate the efficacy at week 52 of subcutaneously administered secukinumab monotherapy compared with subcutaneously administered adalimumab monotherapy in patients with active psoriatic arthritis - EXCEED 1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004477-32-AT

Enrollment

850

Registered

2016-11-30

Start date

2017-01-11

Completion date

Unknown

Last updated

2020-02-01

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

Conditions

Psoriatic Arthritis MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Interventions

Trade Name: COSENTYX Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Secukinumab CAS Number: 1229022-83-6

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosis of PsA classified by CASPAR; Rheumatoid factor and anti-CCP antibodies negative; diagnosis of active plaque psoriasis, with at least one psoriatic plaque of =2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis; inadequate control of symptoms with NSAIDs; inadequate control of symptoms with a conventional DMARD. 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 765 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85

Exclusion criteria

Exclusion criteria: - Pregnant or nursing women, evidence of ongoing infectious or malignant process; previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis; subjects taking high potency opioid analgesics; ongoing use of prohibited psoriasis treatments / medications; previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that the efficacy of secukinumab monotherapy (300 mg s.c.) at Week 52 is superior to adalimumab monotherapy (40 mg s.c.) based on the proportion of subjects achieving an American College of Rheumatology 20 (ACR20) response.; Secondary Objective: To demonstrate that: Secukinumab monotherapy (300 mg s.c.) is superior to adalimumab monotherapy (40 mg s.c.) at Week 52, based on the proportion of subjects achieving - PASI90 response. - ACR50 response. The improvement (change) from baseline on secukinumab monotherapy (300 mg s.c.) is superior to adalimumab monotherapy (40 mg s.c.) at Week 52, for the Health Assessment Questionnaire – Disability Index (HAQ-DI©) score. Secukinumab monotherapy (300 mg s.c.) is superior to adalimumab monotherapy (40 mg s.c.) at Week 52, based on the proportion of subjects achieving the resolution of enthesitis. An additional secondary objective is to evaluate the safety and tolerability of secukinumab monotherapy (300 mg s.c.) compared with adalimumab monotherapy (40 mg s.c.) as assessed by vital signs, clinical laboratory values, and adverse events monitoring. ;Primary end point(s): American College of Rheumatology 20 (ACR20) response;Timepoint(s) of evaluation of this end point: 52 weeks	—

Measure

Time frame

Main Objective: To demonstrate that the efficacy of secukinumab monotherapy (300 mg s.c.) at Week 52 is superior to adalimumab monotherapy (40 mg s.c.) based on the proportion of subjects achieving an American College of Rheumatology 20 (ACR20) response.; Secondary Objective: To demonstrate that: Secukinumab monotherapy (300 mg s.c.) is superior to adalimumab monotherapy (40 mg s.c.) at Week 52, based on the proportion of subjects achieving - PASI90 response. - ACR50 response. The improvement (change) from baseline on secukinumab monotherapy (300 mg s.c.) is superior to adalimumab monotherapy (40 mg s.c.) at Week 52, for the Health Assessment Questionnaire – Disability Index (HAQ-DI©) score. Secukinumab monotherapy (300 mg s.c.) is superior to adalimumab monotherapy (40 mg s.c.) at Week 52, based on the proportion of subjects achieving the resolution of enthesitis. An additional secondary objective is to evaluate the safety and tolerability of secukinumab monotherapy (300 mg s.c.) compared with adalimumab monotherapy (40 mg s.c.) as assessed by vital signs, clinical laboratory values, and adverse events monitoring. ;Primary end point(s): American College of Rheumatology 20 (ACR20) response;Timepoint(s) of evaluation of this end point: 52 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): - PASI90 (a) - ACR50 response (a) - Health Assessment Questionnaire - Disability Index (HAQDI score), relative to baseline (a) - Resolution of enthesitis (a) ;Timepoint(s) of evaluation of this end point: a) at 52 weeks	—

Countries

Australia, Austria, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Ireland, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Netherlands, Poland, Portugal, Russian Federation, Slovakia, Spain, United Kingdom, United States

Contacts

Public ContactDrug Regulatory Affairs

Novartis Pharma GmbH

austria.dra@novartis.com+43 1 86657 0

Outcome results

None listed

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