A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS

• Register: EUCTR
• Last refreshed on: 21 December 2021
• Main ID: EUCTR2017-000679-10-DE
• Date of registration: 24/08/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS
• Scientific title: A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS
• Date of first enrolment: 18/12/2017
• Target sample size: 837
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000679-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: Pts know if they receive PR1 or PR2;but they don`t know the dose of PR1 (150 or 300mg) they receive; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Canada, Chile, Colombia, Czech Republic, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Japan, Korea, Republic of, Mexico, Monaco, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion criteria

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/non biologic 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 = 5mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray.

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 753
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

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 TNFa.
- 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 exclusion criteria may apply,


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

Health Condition(s) or Problem(s) studied

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

Ankylosing spondylitis
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

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/ml milligram(s)/millilitre
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: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: GP2017
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 104 weeks

Main Objective: To demonstrate the proportion of subjects on secukinumab (150 mg s.c. or 300 mg s.c.) with no radiographic progression as measured by mSASSS at Week 104 is superior to subjects on GP2017 (adalimumab biosimilar 40 mg s.c.).

Primary end point(s): No radiographic progression as measured by modified Stoke Ankylosing
Spondylitis Spine Score (mSASSS) for 150 mg sc or 300 mg sc
secukinumab versus GP2017)

Secondary Objective: To demonstrate the change from baseline in mSASSS in subjects on
AIN457 (150mg sc or 300mg sc) is superior to GP2017 at W104
-To demonstrate the proportion of subjects with a syndesmophyte at
baseline with no new syndesmophytes at W104 on AIN457 (150mg sc or
300mg sc) is superior to GP2017
-To evaluate the Berlin SI joint edema score in subjects on AIN457
(150mg sc or 300mg sc) at W104 versus GP2017 (in a subset of subjects
at selected sites)
-To evaluate the ASspiMRI-a Berlin modification score in subjects on
AIN457 (150mg sc or 300mg sc) at W104 versus GP2017 (in a subset of
subjects at selected sites)
-To evaluate ASAS20 response, ASAS40 response, ASAS partial remission
and ASDAS inactive disease in subjects on AIN457 150mg sc compared
to AIN457 300mg sc at W104
-Overall safety and tolerability of AIN457

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 104 weeks

Secondary end point(s): - Change from baseline in modified Stoke Ankylosing Spondylitis Spine
Score (mSASSS).
- No new syndesmophyte as measured by mSASSS.
- Assessment of SpondyloArthritis International Society 20 (ASAS20).
- ASAS 40.
- ASAS partial remission.
- Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease.
- Berlin sacroiliac (SI) joint edema score.
- Ankylosing Spondylitis Spine Magnetic Resonance Imaging - activity
(ASspiMRI-a) Berlin modification score.

Secondary ID(s)

2017-000679-10-GB

CAIN457K2340

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date: 24/10/2017
Contact: