Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) (SURPASS)

Novartis

Status and phase: Completed; Phase 3

Conditions: Ankylosing Spondylitis

Treatments: Biological: AIN457 150 mg; Biological: Placebo; Biological: GP2017 (adalimumab biosimilar)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03259074

CAIN457K2340

Details and patient eligibility

About

The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).

Full description

This was a Phase IIIb, multi-center, randomized, partially-blinded, active-controlled, parallel-group design in subjects with AS. The study consisted of a screening period (up to 10 weeks before randomization), a treatment period (104 weeks), and two follow-up visits (Weeks 112 and 120).

Subjects in both secukinumab dose groups received study treatment at baseline, Weeks 1, 2, 3 and 4 followed by treatment every 4 weeks through Week 100. Subjects in the GP2017 group received study treatment at baseline and every two weeks through Week 102. Subjects could self-administer all secukinumab / placebo and GP2017 doses at the study site or at home. Study treatment (secukinumab vs. GP2017) was provided in an open-label fashion. Subjects in the secukinumab groups were blinded to the dose (150 mg vs. 300 mg). Subjects who received rescue treatment with prohibited medications were allowed to remain in the study but had to discontinue study treatment. Subjects were treated for 104 weeks with two follow-up visits (Weeks 112 and 120).

A total of 859 subjects were randomized to treatment at 171 sites in 30 countries in Europe, North America, South America, and Asia.

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Enrollment: 859 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or non-pregnant, non-nursing female patients at least 18 years of age
• Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic DMARD therapy
• Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10
• Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10)
• Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm)
• hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray

Exclusion criteria

• Patients with total ankylosis of the spine
• Pregnant or nursing (lactating) women
• Evidence of ongoing infectious or malignant process
• Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFα
• Subjects taking high potency opioid analgesics
• Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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859 participants in 3 patient groups

AIN457 150 mg/placebo

Experimental group

Description:

AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100

Treatment:

Biological: Placebo

Biological: AIN457 150 mg

AIN457 300 mg

Experimental group

Description:

AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100

Treatment:

Biological: AIN457 150 mg

GP2017 40mg

Active Comparator group

Description:

GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102

Treatment:

Biological: GP2017 (adalimumab biosimilar)