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

NCT03259074 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CAIN457K2340
• Study Type: interventional
• Target: 859
• Locations: 29 countries
• Sites: 171

Brief Summary

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).

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitis; AS; secukinumab; GP2017; adalimumab biosimilar; mSASSS; ASAS20; ASAS40; adult; r-axSpA; AIN457; radiographic; SURPASS

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set)

  Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score \<= 0.5.

  Baseline and at Week 104

Secondary Outcomes (8)

• Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set)

  Baseline and at Week 104

• Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset)

  Baseline and at Week 104

• Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset)

  Baseline and at Week 104

• Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset)

  Baseline and at Week 104

• Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20)

  Week 104

Study Arms (3)

AIN457 150 mg/placebo

EXPERIMENTAL

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

Biological: Placebo; Biological: AIN457 150 mg

AIN457 300 mg

EXPERIMENTAL

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

Biological: AIN457 150 mg

GP2017 40mg

ACTIVE COMPARATOR

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

Biological: GP2017 (adalimumab biosimilar)

Interventions

Placebo BIOLOGICAL

Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes

AIN457 150 mg/placebo

GP2017 (adalimumab biosimilar) BIOLOGICAL

40 mg in pre-filled syringes was administered subcutaneously

Also known as: adalimumab biosimilar

GP2017 40mg

AIN457 150 mg BIOLOGICAL

150 mg in pre-filled syringes was administered subcutaneously

Also known as: secukinumab

AIN457 150 mg/placebo; AIN457 300 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (171)

Novartis Investigative Site

Mesa, Arizona, 85202, United States

Location

Novartis Investigative Site

Escondido, California, 92025, United States

Location

Novartis Investigative Site

La Mesa, California, 91942, United States

Location

Novartis Investigative Site

San Francisco, California, 94143 0138, United States

Location

Novartis Investigative Site

Gainesville, Florida, 32607, United States

Location

Novartis Investigative Site

Boise, Idaho, 83702, United States

Location

Novartis Investigative Site

Shreveport, Louisiana, 71101, United States

Location

Novartis Investigative Site

Wheaton, Maryland, 20902, United States

Location

Novartis Investigative Site

Great Falls, Montana, 59405, United States

Location

Novartis Investigative Site

Lincoln, Nebraska, 68516, United States

Location

Novartis Investigative Site

Greensboro, North Carolina, 27408, United States

Location

Novartis Investigative Site

Dayton, Ohio, 45402, United States

Location

Novartis Investigative Site

Middleburg Heights, Ohio, 44130, United States

Location

Novartis Investigative Site

Portland, Oregon, 97239, United States

Location

Novartis Investigative Site

Duncansville, Pennsylvania, 16635, United States

Location

Novartis Investigative Site

Memphis, Tennessee, 38119, United States

Location

Novartis Investigative Site

Mesquite, Texas, 75150, United States

Location

Novartis Investigative Site

Kennewick, Washington, 99336, United States

Location

Novartis Investigative Site

Franklin, Wisconsin, 53132, United States

Location

Novartis Investigative Site

Ciudad Autonoma de Bs As, C1428AZF, Argentina

Location

Novartis Investigative Site

Malvern East, Victoria, 3145, Australia

Location

Novartis Investigative Site

Brussels, 1070, Belgium

Location

Novartis Investigative Site

Genk, 3600, Belgium

Location

Novartis Investigative Site

Winnipeg, Manitoba, R3A 1M1, Canada

Location

Novartis Investigative Site

Barrie, Ontario, L4M 6L2, Canada

Location

Novartis Investigative Site

Québec, Quebec, G1V 3M7, Canada

Location

Novartis Investigative Site

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Novartis Investigative Site

Santiago, RM, 7500588, Chile

Location

Novartis Investigative Site

Concepción, Chile

Location

Novartis Investigative Site

Santiago, 8207257, Chile

Location

Novartis Investigative Site

Santiago, Chile

Location

Novartis Investigative Site

Bucaramanga, Santander Department, 0001, Colombia

Location

Novartis Investigative Site

Barranquilla, 080020, Colombia

Location

Novartis Investigative Site

Brno-Zidonice, CZE, 61500, Czechia

Location

Novartis Investigative Site

Brno, 63800, Czechia

Location

Novartis Investigative Site

Prague, 128 50, Czechia

Location

Novartis Investigative Site

Prague, 14900, Czechia

Location

Novartis Investigative Site

Uherské Hradiště, 686 01, Czechia

Location

Novartis Investigative Site

Aalborg, DK 9000, Denmark

Location

Novartis Investigative Site

Copenhagen, 2100, Denmark

Location

Novartis Investigative Site

Joensuu, 80210, Finland

Location

Novartis Investigative Site

Nice, Cedex1, 06001, France

Location

Novartis Investigative Site

Boulogne-Billancourt, 92104, France

Location

Novartis Investigative Site

Le Mans, 72037, France

Location

Novartis Investigative Site

Monaco, 98000, France

Location

Novartis Investigative Site

Paris, 75012, France

Location

Novartis Investigative Site

Paris, 75679, France

Location

Novartis Investigative Site

Toulouse, 31059, France

Location

Novartis Investigative Site

Bad Doberan, 18209, Germany

Location

Novartis Investigative Site

Bayreuth, 95444, Germany

Location

Novartis Investigative Site

Berlin, 12163, Germany

Location

Novartis Investigative Site

Berlin, 13125, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Berlin, 14059, Germany

Location

Novartis Investigative Site

Chemnitz, 09130, Germany

Location

Novartis Investigative Site

Erlangen, 91056, Germany

Location

Novartis Investigative Site

Göttingen, 37075, Germany

Location

Novartis Investigative Site

Hamburg, 20095, Germany

Location

Novartis Investigative Site

Hamburg, 22415, Germany

Location

Novartis Investigative Site

Herne, 44649, Germany

Location

Novartis Investigative Site

Magdeburg, 39110, Germany

Location

Novartis Investigative Site

Planegg, 82152, Germany

Location

Novartis Investigative Site

Ratingen, 40878, Germany

Location

Novartis Investigative Site

Thessaloniki, GR, 564 29, Greece

Location

Novartis Investigative Site

Athens, 115 27, Greece

Location

Novartis Investigative Site

Athens, 145 61, Greece

Location

Novartis Investigative Site

Haifa, 3109601, Israel

Location

Novartis Investigative Site

Haifa, 3339419, Israel

Location

Novartis Investigative Site

Tel Aviv, 6423906, Israel

Location

Novartis Investigative Site

Nishinomiya, Hyōgo, 663 8501, Japan

Location

Novartis Investigative Site

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Novartis Investigative Site

Nankoku, Kochi, 783 8505, Japan

Location

Novartis Investigative Site

Tenri, Nara, 632-8552, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 113-8431, Japan

Location

Novartis Investigative Site

Chuo Ku, Tokyo, 104-8560, Japan

Location

Novartis Investigative Site

Meguro City, Tokyo, 153-8515, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160 8582, Japan

Location

Novartis Investigative Site

Torreón, Coahulia, 27000, Mexico

Location

Novartis Investigative Site

Mexicali, Estado de Baja California, 21100, Mexico

Location

Novartis Investigative Site

Monterrey, Nuevo León, 64460, Mexico

Location

Novartis Investigative Site

Culiacan, State of Mexico, 80000, Mexico

Location

Novartis Investigative Site

San Luis Potosí City, 78213, Mexico

Location

Novartis Investigative Site

Leiden, South Holland, 2333 ZA, Netherlands

Location

Novartis Investigative Site

Amsterdam, 1105 AZ, Netherlands

Location

Novartis Investigative Site

Leeuwarden, 8934 AD, Netherlands

Location

Novartis Investigative Site

Maastricht, 6229 HX, Netherlands

Location

Novartis Investigative Site

Rotterdam, 3079 DZ, Netherlands

Location

Novartis Investigative Site

Jesus Maria, Lima region, 11, Peru

Location

Novartis Investigative Site

San Isidro, Lima region, 27, Peru

Location

Novartis Investigative Site

Santiago de Surco, Lima region, 33, Peru

Location

Novartis Investigative Site

Lima, 1, Peru

Location

Novartis Investigative Site

Manila, 1008, Philippines

Location

Novartis Investigative Site

Quezon City, 1102, Philippines

Location

Novartis Investigative Site

Quezon City, 1118, Philippines

Location

Novartis Investigative Site

Bydgoszcz, 85 168, Poland

Location

Novartis Investigative Site

Dopiewo, 62 069, Poland

Location

Novartis Investigative Site

Krakow, 30 002, Poland

Location

Novartis Investigative Site

Poznan, 61 113, Poland

Location

Novartis Investigative Site

Sopot, 81 756, Poland

Location

Novartis Investigative Site

Almada, 2801 951, Portugal

Location

Novartis Investigative Site

Lisbon, 1050-034, Portugal

Location

Novartis Investigative Site

Lisbon, 1349 019, Portugal

Location

Novartis Investigative Site

Ponte de Lima, 4990 041, Portugal

Location

Novartis Investigative Site

Porto, 4200 319, Portugal

Location

Novartis Investigative Site

Vila Nova de Gaia, 4434 502, Portugal

Location

Novartis Investigative Site

Bucharest, 011172, Romania

Location

Novartis Investigative Site

Bucharest, 030167, Romania

Location

Novartis Investigative Site

Cluj-Napoca, 400006, Romania

Location

Novartis Investigative Site

Barnaul, 656050, Russia

Location

Novartis Investigative Site

Chelyabinsk, 454076, Russia

Location

Novartis Investigative Site

Ivanovo, 153005, Russia

Location

Novartis Investigative Site

Kazan', 420097, Russia

Location

Novartis Investigative Site

Kemerovo, 650029, Russia

Location

Novartis Investigative Site

Kemerovo, 650066, Russia

Location

Novartis Investigative Site

Moscow, 115522, Russia

Location

Novartis Investigative Site

Moscow, 129110, Russia

Location

Novartis Investigative Site

Petrozavodsk, 185019, Russia

Location

Novartis Investigative Site

Saint Petersburg, 190068, Russia

Location

Novartis Investigative Site

Saint Petersburg, 197022, Russia

Location

Novartis Investigative Site

Saint Petersburg, 197341, Russia

Location

Novartis Investigative Site

Ufa, 450005, Russia

Location

Novartis Investigative Site

Yaroslavl, 150003, Russia

Location

Novartis Investigative Site

Yekaterinburg, 620137, Russia

Location

Novartis Investigative Site

Bratislava, Slovak Republic, 813 69, Slovakia

Location

Novartis Investigative Site

Piešťany, SVK, 921 12, Slovakia

Location

Novartis Investigative Site

Bratislava, 85101, Slovakia

Location

Novartis Investigative Site

Košice, 04011, Slovakia

Location

Novartis Investigative Site

Stará Ľubovňa, 06401, Slovakia

Location

Novartis Investigative Site

Seoul, Seocho Gu, 06591, South Korea

Location

Novartis Investigative Site

Gwangju, 61469, South Korea

Location

Novartis Investigative Site

Seoul, 03080, South Korea

Location

Novartis Investigative Site

Seoul, 04763, South Korea

Location

Novartis Investigative Site

Seoul, 05278, South Korea

Location

Novartis Investigative Site

Seoul, 06273, South Korea

Location

Novartis Investigative Site

Villajoyosa, Alicante, 703570, Spain

Location

Novartis Investigative Site

Bilbao, Basque Country, 48013, Spain

Location

Novartis Investigative Site

San Vicente de Barakaldo, Bizkaia, 48903, Spain

Location

Novartis Investigative Site

Santander, Cantabria, 39008, Spain

Location

Novartis Investigative Site

Badalona, Catalonia, 08916, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

A Coruña, Galicia, 15006, Spain

Location

Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

Location

Novartis Investigative Site

Vigo, Pontevedra, 36200, Spain

Location

Novartis Investigative Site

Vitoria-Gasteiz, Vitoria Gasteiz, 01009, Spain

Location

Novartis Investigative Site

Madrid, 28942, Spain

Location

Novartis Investigative Site

Valencia, 46009, Spain

Location

Novartis Investigative Site

Taichung, Taiwan ROC, 40201, Taiwan

Location

Novartis Investigative Site

Dalin, 622, Taiwan

Location

Novartis Investigative Site

Kaohsiung City, 80756, Taiwan

Location

Novartis Investigative Site

Kaohsiung City, 81346, Taiwan

Location

Novartis Investigative Site

Taipei, 10048, Taiwan

Location

Novartis Investigative Site

Istanbul, TUR, 34098, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, 06230, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, 06560, Turkey (Türkiye)

Location

Novartis Investigative Site

Eskişehir, 26040, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, 35340, Turkey (Türkiye)

Location

Novartis Investigative Site

Kocaeli, 41380, Turkey (Türkiye)

Location

Novartis Investigative Site

Christchurch, Dorset, BH23 2JX, United Kingdom

Location

Novartis Investigative Site

London, Edmonton, N18 1QX, United Kingdom

Location

Novartis Investigative Site

London, GBR, SW10 9NH, United Kingdom

Location

Novartis Investigative Site

Portsmouth, Hants, PO6 3LY, United Kingdom

Location

Novartis Investigative Site

Leytonstone, London, E11 1NR, United Kingdom

Location

Novartis Investigative Site

Stoke-on-Trent, Staffordshire, ST6 7AG, United Kingdom

Location

Novartis Investigative Site

Bath, BA1 3NG, United Kingdom

Location

Novartis Investigative Site

Bristol, BS1 3NU, United Kingdom

Location

Novartis Investigative Site

Leicester, LE1 5WW, United Kingdom

Location

Novartis Investigative Site

Liverpool, L9 7AL, United Kingdom

Location

Novartis Investigative Site

London, NW3 2QG, United Kingdom

Location

Novartis Investigative Site

Norwich, NR4 7UY, United Kingdom

Location

Novartis Investigative Site

Torquay, TQ2 7AA, United Kingdom

Location

Novartis Investigative Site

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (2)

• Sieper J, Poddubnyy D. Twenty years of clinical trials in axial spondyloarthritis: what can we learn for the future? Curr Opin Rheumatol. 2021 Jul 1;33(4):363-369. doi: 10.1097/BOR.0000000000000804.

  PMID: 33978600 DERIVED

• Baraliakos X, Ostergaard M, Gensler LS, Poddubnyy D, Lee EY, Kiltz U, Martin R, Sawata H, Readie A, Porter B; SURPASS Study Group. Comparison of the Effects of Secukinumab and Adalimumab Biosimilar on Radiographic Progression in Patients with Ankylosing Spondylitis: Design of a Randomized, Phase IIIb Study (SURPASS). Clin Drug Investig. 2020 Mar;40(3):269-278. doi: 10.1007/s40261-020-00886-7.

  PMID: 31983056 DERIVED

Related Links

• A Plain Language Trial Summary is available on novctrd.com

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

GP2017; adalimumab biosimilar HS016; secukinumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+1 862 778 8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Participant, Care Provider, Investigator and Sponsor are blinded to Secukinumab dose
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study was partially blinded. Subjects, investigators, site personnel, persons performing the assessments, monitors and the Sponsor remained blinded to the dose group of secukinumab (150 mg versus 300 mg)

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 23, 2017
• Study Start: November 30, 2017
• Primary Completion: November 12, 2021
• Study Completion: November 29, 2021
• Last Updated: August 21, 2023
• Results First Posted: March 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

CO (2); FR (7); RU (15); GR (3); RO (3); ME (5); NL (5); PL (5); TW (5); FI (1); DK (2); TU (6); CL (4); CZ (5); CA (4); GB (14); BE (2); SL (5); AR (1); IL (3); AU (1); DE (15); JP (8); US (19); PE (4); PT (6); ES (12); KR (6); PH (3)