STEPin: Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03020199
• Collaborator: (none)
• Enrollment: 196
• Locations: 67
• Arms: 5
• Anticipated Duration (Months): 89.1
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe plaque psoriasis may lead to prolonged symptom free periods by preventing reactivation of old lesions or ultimately totally hindering the occurrence of new lesions, i.e., changing the natural course of the disease (Main Study).

Condition or Disease	Intervention/Treatment	Phase
Plaque Psoriasis	Biological: Secukinumab; Radiation: nbUVB; Biological: Secukinumab; Biological: Secukinumab; Biological: Secukinumab; Drug: Calcipotriol; Drug: Betamethasone	Phase 4

Detailed Description

The overall study population (Main Study and Mechanistic Sub-study) will consist of a total of 205 male and female patients aged between 18 and 40 years inclusive.

Main Study The Main Study will be conducted in patients with new-onset moderate to severe plaque psoriasis not previously treated with any systemic treatment or phototherapy. A total of 160 patients will be randomized to Arm A1 or Arm B1 in approximately 50 sites worldwide. Since a maximum screening failure rate of 20% is expected, approximately 200 patients will be screened.

Mechanistic Sub-study Any patient who consents can participate in the Mechanistic Sub-study. Patients with new-onset plaque psoriasis will be randomized to Arm A1b, Arm A2, or Arm B1b, those with chronic plaque psoriasis will be randomized to Arm C1 and Arm C2 (15 patients each). For Arm A1b or Arm B1b, the first 15 patients will be included on a first come first serve basis.

Safety assessments :Physical examination, Vital signs, Height and body weight, Laboratory evaluations (hematology, clinical chemistry, high-sensitivity C-reactive protein), Electrocardiogram, Pregnancy, Adverse events

Data Analysis The primary efficacy variable is the proportion of patients who achieve PASI 90 at Week 52. The analysis for the primary objective will be based on the full analysis set. For the primary analysis, the following hypothesis testing will be performed: H01: psec = pnbUVB versus HA1: psec ≠ pnbUVB The primary analysis method for PASI 90 response at Week 52 will use an exact logistic regression model with treatment as an explanatory variable and baseline PASI score as covariate. The key secondary variable is the proportion of all randomized patients who achieve PASI 90 at Week 104. In order to reduce selection bias, all patients who do not achieve PASI 90 at Week 52 will also be included in the analysis at Week 104 using the PASI improvement obtained at Week 104 only.

For the key secondary analysis, the following hypothesis testing will be performed:

H02: psec = pnbUVB versus HA2: psec ≠ pnbUVB

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 196 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Multicenter STudy to Evaluate the Effect of Secukinumab 300 mg s.c. Administered During 52 Weeks to Patients Suffering From New-onset Moderate to Severe Plaque Psoriasis as Early Intervention Compared to Standard Treatment With Narrow-band UVB (STEPIn Study)
• Actual Study Start Date: Mar 27, 2017
• Anticipated Primary Completion Date: Aug 30, 2024
• Anticipated Study Completion Date: Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A1 80 patients (65 in Arm A1a and 15 in Arm A1b) with new-onset psoriasis will receive 300 mg secukinumab by s.c. injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive.	Biological: Secukinumab; Secukinumab (AIN457) 300 mg will be administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL.
Active Comparator: B1 80 patients (65 in Arm B1a and 15 in Arm B1b) with new-onset psoriasis will receive 1 or 2 cycles of nb-UVB of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle).Only during the first 4 weeks of each cycle, nb-UVB treatment should be applied in combination with topical calcipotriol 50 μg/g and betamethasone 0.5 mg/g.	Radiation: nbUVB; Narrow-band UVB applied in 1 or 2 cycles, each comprising a period of 12 weeks with 2 to 3 treatment sessions per week totaling 24 to 36 sessions per cycle. The application will be performed according to the investigational site's protocol, taking into account the patient's skin type. A maximum dose of 3 J/cm2 on the body and 1 J/cm2 on the face is recommended; Drug: Calcipotriol; Its a topical treatment for Psoriasis. the concentration it is used is 50mcg/g; Drug: Betamethasone; this is topical cream which is used in 0.5mg/g concentration
Experimental: A2 secukinumab 300 mg s.c. administered at baseline, once weekly at Weeks 1, 2, 3 and 4; and thereafter every 4 weeks until Week 100 inclusive (last dose administered at Week 100)	Biological: Secukinumab; Secukinumab (AIN457) 300 mg will be administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL
Experimental: C1 secukinumab 300 mg s.c. administered at baseline, once weekly at Weeks 1, 2, 3 and 4; and thereafter every 4 weeks until Week 48 inclusive (last dose administered at Week 48)	Biological: Secukinumab; Secukinumab (AIN457) 300 mg will be administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL
Experimental: C2 secukinumab 300 mg s.c. administered at baseline, once weekly at Weeks 1, 2, 3 and 4; and thereafter every 4 weeks until Week 100 inclusive (last dose administered at Week 100)	Biological: Secukinumab; Secukinumab (AIN457) 300 mg will be administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL

Outcome Measures

Primary Outcome Measures

1. The primary efficacy variable is the proportion of patients who achieve Pain Assessment Severity Index (PASI) 90 at Week 52. PASI is measured by dermatologist usung a PASI measurement scale. [52 weeks]

   To demonstrate that early treatment with secukinumab 300 mg s.c. (Arm A1) is superior to standard of care treatment with nb-UVB (Arm B1) in patients with new-onset moderate to severe plaque psoriasis with respect to patients achieving ≥ 90% improvement (reduction) in psoriasis area and severity index (PASI 90) response at Week 52.

Secondary Outcome Measures

1. The key secondary variable is the proportion of all randomized patients who achieve PASI 90 at Week 104 [104 weeks]

   To evaluate the superiority of early treatment with secukinumab (Arm A1) versus nb-UVB (Arm B1) based on the proportion of all randomized patients who achieve at least PASI 90 at Week 104.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Able to understand and communicate with the investigator, willing and capable to comply with all study procedures, and provide written signed and dated informed consent (personally or by a witness) before any assessment is performed

• Aged 18 to 40 years inclusive

• New-onset plaque psoriasis with appearance of the first psoriasis plaques within the last 12 months before randomization and naïve to any systemic treatment and phototherapy (Arms A1, A2 and Arm B1)

• Chronic plaque psoriasis with appearance of the first psoriasis symptoms 5 years or longer and intolerance or inadequate response to phototherapy or any systemic treatment including biologicals, except for IL-17A inhibitors (Arm C1 and Arm C2)

• Moderate to severe plaque psoriasis defined at screening and baseline by PASI ≥ 10, and body surface area (BSA) ≥ 10%, and investigator's global assessment (IGA mod 2011) ≥ 3

Exclusion Criteria:

• Forms of psoriasis other than plaque-type (e.g., pustular, erythrodermic, guttate, light sensitive, and drug induced)

• Ongoing use of prohibited treatments

• Previous treatment with phototherapy or any systemic treatment

• Pregnant or nursing (lactating) women

• Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the Treatment Epoch or longer if required by locally-approved prescribing information (e.g., 20 weeks in the EU)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires	Argentina	1181
2	Novartis Investigative Site	Buenos Aires		Argentina	C1425DKG
3	Novartis Investigative Site	Pleven		Bulgaria	5800
4	Novartis Investigative Site	Plovdiv		Bulgaria	4002
5	Novartis Investigative Site	Sofia		Bulgaria	1407
6	Novartis Investigative Site	Sofia		Bulgaria	1431
7	Novartis Investigative Site	Sofia		Bulgaria	1632
8	Novartis Investigative Site	Surrey	British Columbia	Canada	V3V 0C6
9	Novartis Investigative Site	Halifax	Nova Scotia	Canada	B3H 1Z2
10	Novartis Investigative Site	Markham	Ontario	Canada	L3P 1X2
11	Novartis Investigative Site	Sudbury	Ontario	Canada	P3C 1X8
12	Novartis Investigative Site	Toronto	Ontario	Canada	M3H 5Y8
13	Novartis Investigative Site	Brno		Czechia	656 91
14	Novartis Investigative Site	Pardubice		Czechia	532 03
15	Novartis Investigative Site	Aarhus		Denmark	8000
16	Novartis Investigative Site	Hellerup		Denmark	2900
17	Novartis Investigative Site	Tallinn		Estonia	10138
18	Novartis Investigative Site	Tallinn		Estonia	13419
19	Novartis Investigative Site	Tartu		Estonia	51014
20	Novartis Investigative Site	Tampere		Finland	33100
21	Novartis Investigative Site	Turku		Finland	FIN-20100
22	Novartis Investigative Site	Bad Bentheim		Germany	48455
23	Novartis Investigative Site	Berlin		Germany	10789
24	Novartis Investigative Site	Berlin		Germany	13353
25	Novartis Investigative Site	Erlangen		Germany	91054
26	Novartis Investigative Site	Frankfurt		Germany	60590
27	Novartis Investigative Site	Luebeck		Germany	23538
28	Novartis Investigative Site	Potsdam		Germany	14467
29	Novartis Investigative Site	Quedlinburg		Germany	06484
30	Novartis Investigative Site	Budapest		Hungary	1137
31	Novartis Investigative Site	Gyor		Hungary	H-9023
32	Novartis Investigative Site	Nyíregyháza		Hungary	4400
33	Novartis Investigative Site	Szolnok		Hungary	5000
34	Novartis Investigative Site	Bergen		Norway	NO-5021
35	Novartis Investigative Site	Oslo		Norway	N-0372
36	Novartis Investigative Site	Tromsø		Norway	N-9038
37	Novartis Investigative Site	Trondheim		Norway	N-7006
38	Novartis Investigative Site	Bialystok		Poland	15-879
39	Novartis Investigative Site	Bydgoszcz		Poland	85-094
40	Novartis Investigative Site	Gdansk		Poland	80 952
41	Novartis Investigative Site	Gdansk		Poland	80-803
42	Novartis Investigative Site	Krakow		Poland	31-070
43	Novartis Investigative Site	Lodz		Poland	90-436
44	Novartis Investigative Site	Lodz		Poland	90-647
45	Novartis Investigative Site	Lublin		Poland	20-079
46	Novartis Investigative Site	Iasi		Romania	700401
47	Novartis Investigative Site	Badalona	Catalunya	Spain	08916
48	Novartis Investigative Site	Barcelona	Catalunya	Spain	08003
49	Novartis Investigative Site	Barcelona	Catalunya	Spain	08036
50	Novartis Investigative Site	Alicante	Comunidad Valenciana	Spain	03010
51	Novartis Investigative Site	Valencia	Comunidad Valenciana	Spain	46014
52	Novartis Investigative Site	Alcorcon	Madrid	Spain	28922
53	Novartis Investigative Site	Barcelona		Spain	08041
54	Novartis Investigative Site	Las Palmas de Gran Canaria		Spain	35010
55	Novartis Investigative Site	Madrid		Spain	28006
56	Novartis Investigative Site	Madrid		Spain	28031
57	Novartis Investigative Site	Madrid		Spain	28041
58	Novartis Investigative Site	Goethenburg		Sweden
59	Novartis Investigative Site	Malmo		Sweden	214 28
60	Novartis Investigative Site	Stockholm		Sweden	17176
61	Novartis Investigative Site	Geneve		Switzerland	1205
62	Novartis Investigative Site	Lausanne		Switzerland	CH-1011
63	Novartis Investigative Site	Zuerich		Switzerland	8091
64	Novartis Investigative Site	Bradford	West Yorkshire	United Kingdom	BD5 0NA
65	Novartis Investigative Site	Leeds	West Yorkshire	United Kingdom	LS7 4SA
66	Novartis Investigative Site	London		United Kingdom	SE1 9RT
67	Novartis Investigative Site	Salford		United Kingdom	M6 8HD

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: NCT03020199
• Other Study ID Numbers: CAIN457A2322
• First Posted: Jan 13, 2017
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: Psoriasis
• Additional relevant MeSH terms: Psoriasis; Betamethasone; Calcipotriene; Antibodies, Monoclonal

Study Results

No Results Posted as of Jul 22, 2022