The objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 2 primary endpoints are:
• Proportion of subjects achieving a PASI 90 response at Week 52; superiority
of risankizumab vs. secukinumab.
• Proportion of subjects achieving a PASI 90 response at Week 16;
noninferiority of risankizumab vs. secukinumab with non-inferiority margin of
12%.
Secondary outcome
The multiplicity-controlled key secondary endpoints are:
• Proportion of subjects achieving a PASI 100 response at Week 52; superiority
of risankizumab vs. secukinumab;
• Proportion of subjects achieving a sPGA 0 or 1 at Week 52; superiority of
risankizumab vs. secukinumab;
• Proportion of subjects achieving a PASI 75 response at Week 52; superiority
of risankizumab vs. secukinumab.
Other efficacy endpoints include change and percent change from baseline in
PASI and body surface area (BSA) as well as multiple levels of PASI and sPGA
responses at all visits.
Background summary
Psoriasis is a chronic debilitating immune*mediated disease characterized by
marked inflammation of the skin that results in thick, erythematous, scaly
plaques involving the skin. In most developed ountries, prevalence is between
1.5 and 5%. Twenty*five percent of patients have moderate to severe
disease with a considerable negative impact on psychosocial and economic
status. While the majority of mild psoriasis patients are managed with
topical therapies, those with moderate or severe and/or refractory disease
usually require phototherapy and/or systemic therapy.
Despite the availability of various psoriasis therapies, many subjects still do
not respond adequately to these treatments, or gradually lose response over
time.
This study will provide essential data comparing risankizumab (anti-IL-23
therapy) vs. secukinumab (anti-IL-17A therapy) for the treatment of patients
with moderate to severe plaque psoriasis who are candidates for systemic
therapy.
Study objective
The objective of this study is to evaluate the efficacy and safety of
risankizumab compared with secukinumab for the treatment of adult subjects with
moderate to severe plaque psoriasis who are candidates for systemic therapy.
Study design
This is a Phase-3 multi-center, randomized, open label, efficacy
assessor-blinded study. The study compromises a 30*day screening period, a 52*
week open*label study period and a 16*week follow*up period. The follow*up
period consists of a follow*up phone call 20 weeks after the last study drug
dose.
Intervention
Subjects who are eligible for this study, will be randomized to receive
risankizumab or secukinumab in a 1:1 ratio. The study is
designed to randomize approximately 310 subjects (155 subjects/arm).
Subjects in the risankizumab arm will receive risankizumab subcutaneous at week
0, 4 and then every 12 weeks thereafter. Subjects in the secukinumab arm will
receive secukinumab subcutaneous in week 0, 1, 2, 3,4 and then every 4 weeks.
Study burden and risks
There will be higher burden for subjects participating in this study compared
to their standard of care. Subjects will be visiting the hospital more
frequently. During these visits study procedures will be performed including
blood sampling.
Subjects will be tested for TB, Hepatitis C/Hepatitis B and HIV. Women of
Childbearing Potential should practice a method of birth control, during the
study through at least 20 weeks after the last dose of study drug and are
tested for pregnancy.
The most common side effects reported during studies of risankizumab were
nasopharyngitis, headache, back pain and arthralgia.
Wegalaan 9
Hoofddorp 2132 JD
NL
Wegalaan 9
Hoofddorp 2132 JD
NL
Listed location countries
Age
Inclusion criteria
1. Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug:
• Serum aspartate transaminase (AST) < 2 × ULN;
• Serum alanine transaminase (ALT) < 2 × ULN;
• Serum direct bilirubin <= 2.0 mg/dL; except for subjects with isolated elevation of indirect bilirubin relating to a confirmed diagnosis of Gilbert syndrome;
• Total white blood cell (WBC) count > 3,000/µL;
• Absolute neutrophil count (ANC) > 1,500/µL;
• Platelet count > 100,000/µL;
• Hemoglobin > 8 g/dL.;2. Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit;;3. Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis
• Subject has >= 10% BSA psoriasis involvement, sPGA score of >= 3, and PASI >= 12 at Screening and Baseline Visit;;4. Subject must be a candidate for systemic therapy as assessed by the investigator;;5. Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound.
Exclusion criteria
1. No history of:
• Erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis;
• Active skin disease other than psoriasis that could interfere with the assessment of psoriasis;
• Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB /PPD test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines. The patient will not be eligible for randomization if latent tuberculosis is present and is untreated as per local guidelines.
• Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold) prior to Baseline Visit, as assessed by the investigator;;2. No history of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix;;3. No previous exposure to risankizumab;;4. No previous exposure to secukinumab;;5. Subject must not have been treated with any investigational drug within 30 days or 5 half lives of the drug (whichever is longer) prior to the first dose.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-004932-12-NL |
| CCMO | NL65033.078.18 |
| Other | nog niet bekend |