Efficacy of secukinumab compared to adalimumab in patients with psoriatic arthritis

• Register: EUCTR
• Last refreshed on: 1 February 2020
• Main ID: EUCTR2015-004477-32-DK
• Date of registration: 14/12/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: Efficacy of secukinumab compared to adalimumab in patients with psoriatic arthritis
• Scientific title: 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
• Date of first enrolment: 10/02/2017
• Target sample size: 853
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004477-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Medical Information
• Affiliation: Novartis Healthcare A/S

• Name: Medical Information
• Affiliation: Novartis Healthcare A/S

Key inclusion & exclusion 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 738
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 115

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Trade Name: COSENTYX
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Trade Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Other descriptive name: ADALIMUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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.

Timepoint(s) of evaluation of this end point: 52 weeks

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.

Primary end point(s): American College of Rheumatology 20 (ACR20) response

Secondary Outcome(s)

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

Secondary ID(s)

2015-004477-32-DE

CAIN457F2366

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date: 23/01/2017
Contact: