Study in patients with moderate to severe plaque psoriasis to assess efficacy of secukinumab compared to Fumaderm®

• Register: EUCTR
• Last refreshed on: 10 October 2016
• Main ID: EUCTR2014-005258-20-DE
• Date of registration: 06/02/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma GmbH
• Public title: Study in patients with moderate to severe plaque psoriasis to assess efficacy of secukinumab compared to Fumaderm®
• Scientific title: A 24-week, randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm® in adults with moderate to severe plaque psoriasis - PRIME
• Date of first enrolment: 13/03/2015
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005258-20
• 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: study with blinded assessment of the efficacy If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator, and must give a written, signed and dated informed consent before any study related activity is performed.
2. Men or women must be at least 18 years of age at the time of screening
3. Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization
4. Patients with moderate to severe plaque psoriasis who are candidates for systemic therapy as defined at randomization by:
- PASI score of >10
- Affected body surface area (BSA) > 10%
- DLQI >10
5. Patients for whom topical psoriasis treatment alone is no longer sufficient. Inadequate response, intolerance or contraindication to topical psoriasis treatment must have been documented in the patient’s medical history or reported by the patient or determined by the investigator at screening.
6. Patients for whom Fumaderm® is expected to be the patient-individually optimized standard therapy under consideration of Fumaderm®, Ciclosporin, Methotrexate or phototherapy (Balneophototherapy, oral PUVA, NB-UVB) as per investigator’s discretion.
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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion criteria:
1. Forms of psoriasis other than plaque psoriasis
2. Drug-induced psoriasis
3. Previous exposure to biologic drugs directly targeting IL-17A or IL-17RA, or prior treatmt. with Fumaderm® or other fumaric acid derivatives
4. Previous systemic treatmt. of plaque psoriasis or known contraindication for systemic therapy at baseline
5. Ongoing use of other prohibited psoriasis + non-psoriasis treatmt. Washout periods detailed in the prot. have to be adhered to. All other previous non-psoriasis concomitant treatmt. must be on a stable dose at least 4 wks. before randomization
6. Plans for admin. of live vaccines during the study period
7. Use of any other investigational drugs within 4 wks. of study drug initiation or within a period of 5 half-lives of the investigational treatmt., whichever is longer
8. Known hypersensitivity to secukinumab and/or other components of secukinumab, i.e. sucrose, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, L-methionine
9. Pats. with latex hypersensitivity
10. Known hypersensitivity to fumaric acid derivatives, or other components of Fumaderm® INITIAL/Fumaderm®
11. Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations incl. but not limited to recurrent respiratory and/or urinary tract infections or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test at screening. Subjects with a positive or indeterminate QuantiFERON TB-Gold may participate in the study if further full tuberculosis work up completed at least 12 wks. prior to randomization establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatmt. must have been initiated + maintained according to local country guidelines for at least 4 wks. prior to randomization
12. Past medical history record of,or current infection with, HIV, hepatitis B or hepatitis C prior to randomization
13. Pats. with Crohn´s disease
14. Pats. with severe liver diseases
15. Pats. with severe gastrointestinal diseases incl. but not limited to ventricular + duodenal ulcers
16. Pats. with severe kidney diseases or serum creatinine above 1 x ULN. Pats. with serum creatinine above 1 x ULN may be incl. if the lab. abnormality is deemed clinically irrelevant by the investig.
17. Pats. with known hematological disease or with any of the following hematology lab results >1xULN or <1x LLN at screening: erythrocyte count, leukocyte count, lymphocyte count, monocytes, neutrophils, basophils, eosinophils, platelets, hemoglobin. Pats. with hematology lab results >1x ULN or<1x LLN may be included if the lab. abnormality is deemed clinically irrelevant by the investig.
18. Women
a. who are pregnant or breast feeding (pregnancy defined as the state of a female after conception + until the termination of gestation, confirmed by a positive hCG lab. test. Pats. with a positive hCG lab. test may participate in the study if they are postmenopausal or if further work up by a qualified physician establishes conclusively that the pat. is not pregnant + does not suffer from malignancy or any other condition that would constitute an excl. criterion.
b. who are menstruating + capable of becoming pregnant + not practicing a medically approved method of contraception (Pearl Index <1) during + up to at least 16 wks. after the end of treatmt. A neg. pregnancy test (serum) for all women is required

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

Health Condition(s) or Problem(s) studied

chronic moderate to severe plaque type psoriasis
MedDRA version: 18.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Intervention(s)

Trade Name: Cosentyx
Product Name: Secukinumab auto-injector
Product Code: AIN457
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SECUKINUMAB
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: Fumaderm® initial
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Dimethylfumarat
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz
CAS Number: 8000050-76-2
Other descriptive name: ETHYL FUMARATE CALCIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 67-
INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz
CAS Number: 8000050-77-3
Other descriptive name: ETHYL FUMARATE MAGNESIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz
CAS Number: 8000050-78-4
Other descriptive name: ETHYL FUMARATE ZINC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-

Trade Name: Fumaderm®
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Dimethylfumarat
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz
CAS Number: 8000050-76-2
Other descriptive name: ETHYL FUMARATE CALCIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 87-
INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz
CAS Number: 8000050-77-3
Other descriptive name: ETHYL FUMARATE MAGNESIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz
CAS Number: 8

Primary Outcome(s)

Primary end point(s): The primary endpoint is the demonstration of the superiority of secukinumab compared to Fumaderm® in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 75 responders.

Main Objective: To demonstrate the superiority of secukinumab compared to Fumaderm® in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 75 responders at week 24.

Secondary Objective: To compare efficacy of secukinumab and Fumaderm® on raw PASI and PASI 50/75/90/100 response rates at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
To compare efficacy of secukinumab and Fumaderm® on BSA at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
To compare efficacy of secukinumab and Fumaderm® on IGA mod. 2011 and IGA mod. 2011 0/1-response at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
To compare the effect of secukinumab and Fumaderm® on DLQI and DLQI 0/1 response at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
To compare the effect of secukinumab and Fumaderm® on SF-36 response at weeks 4, 16 and 24.
To compare the effect of secukinumab and Fumaderm® on NAPSI response at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.

Timepoint(s) of evaluation of this end point: at week 24

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: see field E.5.2

Secondary end point(s): The secondary endpoints are:
- To compare efficacy of secukinumab and Fumaderm® on raw PASI and PASI 50/75/90/100 response rates at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
- To compare efficacy of secukinumab and Fumaderm® on BSA at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
- To compare efficacy of secukinumab and Fumaderm® on IGA mod. 2011 and IGA mod. 2011 0/1-response at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
- To compare the effect of secukinumab and Fumaderm® on DLQI and DLQI 0/1 response at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
- To compare the effect of secukinumab and Fumaderm® on SF-36 response at weeks 4, 16 and 24.
- To compare the effect of secukinumab and Fumaderm® on NAPSI response at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.

Secondary ID(s)

CAIN457ADE06

Source(s) of Monetary Support

Novartis Pharma GmbH