Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis (EXCEED 1)

Novartis

Status and phase: Completed; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Biological: Adalimumab; Biological: Secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02745080

2015-004477-32 (EudraCT Number)

CAIN457F2366

Details and patient eligibility

About

This was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).

Full description

The total maximum study duration, including the screening period was up to 76 weeks.

At Baseline, patients whose eligibility was confirmed were randomized to 1 of 2 groups (1:1): Group 1 (secukinumab 300 mg) or Group 2 (adalimumab 40 mg).

In order to maintain the blind, both groups received 1 or 2 placebo s.c. injections to keep consistency in the number of injections at each dosing visit. Secukinumab (300 mg) was available in 2 x 1.0 mL pre-filled syringes (PFS) and adalimumab was available in 1 x 0.4 mL PFS. Placebo (1.0 and 0.5 mL PFS) was also available.

Secukinumab 300 mg s.c injection (2 x 1 mL PFS) was administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks to Week 48.

Adalimumab 40 mg (1 x 0.4 mL PFS) was administered at Baseline followed by dosing every 2 weeks until Week 50.

Enrollment: 853 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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853 participants in 2 patient groups

Secukinumab 300 mg s.c.

Experimental group

Description:

Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.

Treatment:

Biological: Secukinumab

Adalimumab 40 mg s.c.

Active Comparator group

Description:

Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.

Treatment:

Biological: Adalimumab