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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT03259074
Collaborator
(none)
860
Enrollment
170
Locations
3
Arms
48
Actual Duration (Months)
5.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the impact of secukinumab on progression of structural damage in the spine, as measured by the mSASSS in patients with AS.

Condition or Disease Intervention/Treatment Phase
  • Biological: Secukinumab
  • Biological: GP2017 (adalimumab biosimilar)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
860 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The Participant, Care Provider, Investigator and Sponsor are blinded to Secukinumab dose
Primary Purpose:
Treatment
Official Title:
A Randomized, Partially-blinded 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
Actual Study Start Date :
Nov 30, 2017
Actual Primary Completion Date :
Oct 21, 2021
Actual Study Completion Date :
Nov 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Secukinumab 150 mg s.c.

Secukinumab 150 mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100

Biological: Secukinumab
Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio
Experimental: Secukinumab 300 mg s.c.

Secukinumab 300 mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100

Biological: Secukinumab
Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio
Experimental: GP2017 (adalimumab biosimilar) 40mg s.c.

GP2017 (adalimumab biosimilar) 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 102

Biological: GP2017 (adalimumab biosimilar)
Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio

Outcome Measures

Primary Outcome Measures

  1. No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [104 weeks]

    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.)

Secondary Outcome Measures

  1. Change from baseline in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [104 weeks]

    To demonstrate the change from baseline in mSASSS in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) is superior to GP2017 (adalimumab biosimilar 40 mg s.c.) at Week 104

  2. No new syndesmophytes as measured by mSASSS [104 weeks]

    The proportion of subjects with no new syndesmophytes is defined as the number of patients with a syndesmophyte at baseline who develops one by week 104, as measured by mSASSS

  3. Assessment of SpondyloArthritis International Society 20 (ASAS20) [104 weeks]

    ASAS20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit in the remaining domain

  4. ASAS40 [104 weeks]

    ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain

  5. ASAS partial remission [104 weeks]

    ASAS partial remission is defined as a value not above 2 units in each of four main domains on a scale of 0 to 10

  6. Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease [104 weeks]

    An ASDAS inactive disease response is a score of <1.3 on a composite index to assess disease activity in Ankylosing Spondylitis. Parameters include spinal pain, the patient's global assessment of disease activity, peripheral pain/swelling, duration of morning stiffness and C-reactive protein (CRP) in mg/L.

  7. Berlin sacroiliac (SI) joint edema score [104 weeks]

    To evaluate the Berlin SI joint edema score in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) at Week 104 versus GP2017 (adalimumab biosimilar 40 mg s.c.)

  8. Ankylosing Spondylitis Spine Magnetic Resonance Imaging - activity (ASspiMRI-a) Berlin modification score [104 weeks]

    To evaluate the ASspiMRI-a Berlin modification score in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) at Week 104 versus GP2017 (adalimumab biosimilar 40 mg s.c.)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Mesa Arizona United States 85202
2 Novartis Investigative Site Escondido California United States 92025
3 Novartis Investigative Site La Mesa California United States 91942
4 Novartis Investigative Site San Francisco California United States 94143 0138
5 Novartis Investigative Site Gainesville Florida United States 32607
6 Novartis Investigative Site Boise Idaho United States 83702
7 Novartis Investigative Site Shreveport Louisiana United States 71101
8 Novartis Investigative Site Wheaton Maryland United States 20902
9 Novartis Investigative Site Great Falls Montana United States 59405
10 Novartis Investigative Site Lincoln Nebraska United States 68516
11 Novartis Investigative Site Greensboro North Carolina United States 27408
12 Novartis Investigative Site Dayton Ohio United States 45402
13 Novartis Investigative Site Middleburg Heights Ohio United States 44130
14 Novartis Investigative Site Portland Oregon United States 97239
15 Novartis Investigative Site Duncansville Pennsylvania United States 16635
16 Novartis Investigative Site Memphis Tennessee United States 38119
17 Novartis Investigative Site Mesquite Texas United States 75150
18 Novartis Investigative Site Kennewick Washington United States 99336
19 Novartis Investigative Site Franklin Wisconsin United States 53132
20 Novartis Investigative Site Ciudad Autonoma de Bs As Argentina C1428AZF
21 Novartis Investigative Site Malvern East Victoria Australia 3145
22 Novartis Investigative Site Genk Belgium 3600
23 Novartis Investigative Site Winnipeg Manitoba Canada R3A 1M1
24 Novartis Investigative Site Barrie Ontario Canada L4M 6L2
25 Novartis Investigative Site Trois Rivieres Quebec Canada G8Z 1Y2
26 Novartis Investigative Site Quebec Canada G1V 3M7
27 Novartis Investigative Site Santiago RM Chile 7500588
28 Novartis Investigative Site Concepcion Chile
29 Novartis Investigative Site Santiago Chile 8207257
30 Novartis Investigative Site Santiago Chile
31 Novartis Investigative Site Bucaramanga Santander Colombia 0001
32 Novartis Investigative Site Barranquilla Colombia 080020
33 Novartis Investigative Site Brno-Zidonice CZE Czechia 61500
34 Novartis Investigative Site Brno Czechia 63800
35 Novartis Investigative Site Praha 11 Czechia 148 00
36 Novartis Investigative Site Praha 2 Czechia 128 50
37 Novartis Investigative Site Uherske Hradiste Czechia 686 01
38 Novartis Investigative Site Aalborg Denmark DK 9000
39 Novartis Investigative Site Copenhagen Denmark 2100
40 Novartis Investigative Site Joensuu Finland 80210
41 Novartis Investigative Site Nice Cedex1 France 06001
42 Novartis Investigative Site Boulogne Billancourt France 92104
43 Novartis Investigative Site Le Mans France 72037
44 Novartis Investigative Site Monaco France 98000
45 Novartis Investigative Site Paris Cedex 14 France 75679
46 Novartis Investigative Site Paris France 75012
47 Novartis Investigative Site Toulouse France 31059
48 Novartis Investigative Site Bad Doberan Germany 18209
49 Novartis Investigative Site Bayreuth Germany 95444
50 Novartis Investigative Site Berlin Germany 12163
51 Novartis Investigative Site Berlin Germany 13125
52 Novartis Investigative Site Berlin Germany 13353
53 Novartis Investigative Site Berlin Germany 14059
54 Novartis Investigative Site Chemnitz Germany 09130
55 Novartis Investigative Site Erlangen Germany 91056
56 Novartis Investigative Site Gottingen Germany 37075
57 Novartis Investigative Site Hamburg Germany 20095
58 Novartis Investigative Site Hamburg Germany 22415
59 Novartis Investigative Site Herne Germany 44649
60 Novartis Investigative Site Magdeburg Germany 39110
61 Novartis Investigative Site Planegg Germany 82152
62 Novartis Investigative Site Ratingen Germany 40878
63 Novartis Investigative Site Thessaloniki GR Greece 564 29
64 Novartis Investigative Site Athens Greece 115 27
65 Novartis Investigative Site Athens Greece 145 61
66 Novartis Investigative Site Haifa Israel 3109601
67 Novartis Investigative Site Haifa Israel 3339419
68 Novartis Investigative Site Tel Aviv Israel 6423906
69 Novartis Investigative Site Nishinomiya Hyogo Japan 663 8501
70 Novartis Investigative Site Kita-gun Kagawa Japan 761-0793
71 Novartis Investigative Site Nankoku city Kochi Japan 783 8505
72 Novartis Investigative Site Tenri Nara Japan 632-8552
73 Novartis Investigative Site Bunkyo ku Tokyo Japan 113-8431
74 Novartis Investigative Site Chuo ku Tokyo Japan 104-8560
75 Novartis Investigative Site Meguro Tokyo Japan 153-8515
76 Novartis Investigative Site Shinjuku-ku Tokyo Japan 160 8582
77 Novartis Investigative Site Seoul Seocho Gu Korea, Republic of 06591
78 Novartis Investigative Site Gwangju Korea, Republic of 61469
79 Novartis Investigative Site Seoul Korea, Republic of 03080
80 Novartis Investigative Site Seoul Korea, Republic of 04763
81 Novartis Investigative Site Seoul Korea, Republic of 05278
82 Novartis Investigative Site Seoul Korea, Republic of 06273
83 Novartis Investigative Site Mexicali Baja California Mexico 21100
84 Novartis Investigative Site Torreon Coahulia Mexico 27000
85 Novartis Investigative Site Culiacan MEX Mexico 80000
86 Novartis Investigative Site Monterrey Nuevo Leon Mexico 64460
87 Novartis Investigative Site San Luis potosi Mexico 78213
88 Novartis Investigative Site Leiden Zuid-Holland Netherlands 2333 ZA
89 Novartis Investigative Site Amsterdam Netherlands 1105 AZ
90 Novartis Investigative Site Leeuwarden Netherlands 8934 AD
91 Novartis Investigative Site Maastricht Netherlands 6229 HX
92 Novartis Investigative Site Rotterdam Netherlands 3079 DZ
93 Novartis Investigative Site Jesus Maria Lima Peru 11
94 Novartis Investigative Site San Isidro Lima Peru 27
95 Novartis Investigative Site Santiago de Surco Lima Peru 33
96 Novartis Investigative Site Lima Peru 1
97 Novartis Investigative Site Manila Philippines 1008
98 Novartis Investigative Site Quezon City Philippines 1102
99 Novartis Investigative Site Quezon City Philippines 1118
100 Novartis Investigative Site Bydgoszcz Poland 85 168
101 Novartis Investigative Site Dopiewo Poland 62 069
102 Novartis Investigative Site Krakow Poland 30 002
103 Novartis Investigative Site Poznan Poland 61 113
104 Novartis Investigative Site Sopot Poland 81 756
105 Novartis Investigative Site Almada Portugal 2801 951
106 Novartis Investigative Site Lisboa Portugal 1050-034
107 Novartis Investigative Site Lisboa Portugal 1349 019
108 Novartis Investigative Site Ponte de Lima Portugal 4990 041
109 Novartis Investigative Site Porto Portugal 4200 319
110 Novartis Investigative Site Vila Nova de Gaia Portugal 4434 502
111 Novartis Investigative Site Bucharest Romania 030167
112 Novartis Investigative Site Bucuresti Romania 011172
113 Novartis Investigative Site Cluj Napoca Romania 400006
114 Novartis Investigative Site Barnaul Russian Federation 656050
115 Novartis Investigative Site Chelyabinsk Russian Federation 454076
116 Novartis Investigative Site Ekaterinburg Russian Federation 620137
117 Novartis Investigative Site Ivanovo Russian Federation 153005
118 Novartis Investigative Site Kazan Russian Federation 420097
119 Novartis Investigative Site Kemerovo Russian Federation 650029
120 Novartis Investigative Site Kemerovo Russian Federation 650066
121 Novartis Investigative Site Moscow Russian Federation 115522
122 Novartis Investigative Site Moscow Russian Federation 129110
123 Novartis Investigative Site Petrozavodsk Russian Federation 185019
124 Novartis Investigative Site Saint Petersburg Russian Federation 197022
125 Novartis Investigative Site Saint Petersburg Russian Federation 197341
126 Novartis Investigative Site St Petersburg Russian Federation 190068
127 Novartis Investigative Site Ufa Russian Federation 450005
128 Novartis Investigative Site Yaroslavl Russian Federation 150003
129 Novartis Investigative Site Bratislava Slovak Republic Slovakia 813 69
130 Novartis Investigative Site Piestany SVK Slovakia 921 12
131 Novartis Investigative Site Bratislava Slovakia 85101
132 Novartis Investigative Site Kosice Slovakia 04011
133 Novartis Investigative Site Stara Lubovna Slovakia 06401
134 Novartis Investigative Site Villajoyosa Alicante Spain 703570
135 Novartis Investigative Site San Vicente De Barakaldo Bizkaia Spain 48903
136 Novartis Investigative Site Santander Cantabria Spain 39008
137 Novartis Investigative Site Badalona Catalunya Spain 08916
138 Novartis Investigative Site Barcelona Catalunya Spain 08003
139 Novartis Investigative Site La Coruna Galicia Spain 15006
140 Novartis Investigative Site Santiago de Compostela Galicia Spain 15706
141 Novartis Investigative Site Bilbao Pais Vasco Spain 48013
142 Novartis Investigative Site Vigo Pontevedra Spain 36200
143 Novartis Investigative Site Vitoria Vitoria Gasteiz Spain 01009
144 Novartis Investigative Site Madrid Spain 28942
145 Novartis Investigative Site Valencia Spain 46009
146 Novartis Investigative Site Taichung Taiwan ROC Taiwan 40201
147 Novartis Investigative Site Dalin Taiwan 622
148 Novartis Investigative Site Kaohsiung Taiwan 80756
149 Novartis Investigative Site Kaohsiung Taiwan 81346
150 Novartis Investigative Site Taipei Taiwan 10048
151 Novartis Investigative Site Istanbul TUR Turkey 34098
152 Novartis Investigative Site Ankara Turkey 06230
153 Novartis Investigative Site Ankara Turkey 06560
154 Novartis Investigative Site Eskisehir Turkey 26040
155 Novartis Investigative Site Izmir Turkey 35340
156 Novartis Investigative Site Kocaeli Turkey 41380
157 Novartis Investigative Site Christchurch Dorset United Kingdom BH23 2JX
158 Novartis Investigative Site London Edmonton United Kingdom N18 1QX
159 Novartis Investigative Site London GBR United Kingdom SW10 9NH
160 Novartis Investigative Site Portsmouth Hants United Kingdom PO6 3LY
161 Novartis Investigative Site Leytonstone London United Kingdom E11 1NR
162 Novartis Investigative Site Stoke on Trent Staffordshire United Kingdom ST6 7AG
163 Novartis Investigative Site Bath United Kingdom BA1 3NG
164 Novartis Investigative Site Bristol United Kingdom BS1 3NU
165 Novartis Investigative Site Leicester United Kingdom LE1 5WW
166 Novartis Investigative Site Liverpool United Kingdom L9 7AL
167 Novartis Investigative Site London United Kingdom NW3 2QG
168 Novartis Investigative Site Norwich United Kingdom NR4 7UY
169 Novartis Investigative Site Torquay United Kingdom TQ2 7AA
170 Novartis Investigative Site Wolverhampton United Kingdom WV10 0QP

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03259074
Other Study ID Numbers:
  • CAIN457K2340
First Posted:
Aug 23, 2017
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
ankylosing spondylitis, AS, secukinumab, GP2017, adalimumab biosimilar, mSASSS, ASAS20
Additional relevant MeSH terms:
Spondylitis
Spondylarthritis
Spondylitis, Ankylosing
Adalimumab

Study Results

No Results Posted as of Jul 12, 2022