Co-Primary- to assess whether ixekizumab Q4W is superior to placebo at Week 12 (Visit 7) in the treatment of pediatric subjects(children and adolescents) with moderate-to-severe plaque psoriasis as measured by PASI 75 and by sPGA (0,1)Gated…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of subjects achieving PASI 75.
Proportion of subjects achieving sPGA (0,1).
Secondary outcome
Proportion of subjects achieving PASI 90.
Proportion of subjects achieving sPGA (0).
Proportion of subjects achieving PASI 100.
Proportion of subjects achieving PASI 75.
Proportion of subjects achieving sPGA (0,1).
Improvement *4 for subjects who had a baseline Itch NRS score *4.
Background summary
Pediatric plaque Ps affects approximately 1% of children and adolescents
globally (Gelfand et al. 2005; Napolitano et al. 2016). It is estimated that
35% to 50% of adults with psoriasis developed their disease before 20 years of
age (De Jager et al. 2009). In a report by Gelfand et al. (2005),
the prevalence of plaque Ps in children in the United Kingdom was 0.55% for
those aged 0 to 9 years and 1.37% for those aged 10 to 19 years. Pediatric
plaque Ps is especially burdensome because it often presents on the face and
scalp, as well as other highly visible areas. Nonbiologic
topical therapies have been the mainstay of treatment due to lack of approved
therapies for plaque Ps in children. Currently, there are few systemic
therapies for pediatric plaque Ps, and most have significant side effects or
are not as effective as desired (Bronckers et al. 2015).
Currently, there is an unmet medical need for effective and safe therapies for
children and adolescents with moderate-to-severe psoriasis. Both the PIP and
Pediatric Study Plan will focus on pediatric subjects with moderate-to-severe
plaque Ps from 6 to <18 years of age.
This study will explore specific response in the Pediatric Population. The
risks and benefits in the Pediatric Population are expected to be similar to
those in adults with plaque Ps. There is no specific difference in the
mechanism of the disease; therefore, no difference in the safety profile
is expected between adults, adolescents, and children.
Study objective
Co-Primary
- to assess whether ixekizumab Q4W is superior to placebo at Week 12 (Visit 7)
in the treatment of pediatric subjects
(children and adolescents) with moderate-to-severe plaque psoriasis as measured
by PASI 75 and by sPGA (0,1)
Gated Secondary
- to assess whether ixekizumab Q4W is superior to placebo at Week 12 as
measured by:
* - PASI 90
* - sPGA (0)
* - PASI 100
* - PASI 75
* - sPGA (0,1)
* - Itch NRS
Other Secondary
- to assess whether ixekizumab Q4W is superior to placebo
- to summarize the efficacy of ixekizumab Q4W at Week 24 (Visit 10) and Week 48
(Visit 16) as measured by:
* - PASI 75
* - sPGA (0,1)
* - PASI 90
* - sPGA (0)
* - PASI 100
- to evaluate the potential development of anti-ixekizumab antibodies and its
impact on subject efficacy of ixekizumab
- to measure ixekizumab exposure and characterize the pharmacokinetics of
ixekizumab in pediatric subjects
- to assess the relationship between exposure and efficacy and exposure and
immunogenicity
- to assess the safety of ixekizumab
- to compare the efficacy of ixekizumab Q4W and etanercept at Week 12 (Visit 7)
as measured by PASI 75 and by sPGA (0,1) in countries where etanercept is
approved
Study design
Study I1F-MC-RHCD is a Phase 3, multicenter, double-blind, randomized,
placebo-controlled study examining the effects of ixekizumab versus placebo in
subjects from 6 to <18 years of age with moderate-to-severe plaque Ps
(Psoriasis Area and Severity Index [PASI] score *12, sPGA *3, and body surface
area [BSA] *10% at screening and baseline). There is an active-controlled
(etanercept) portion of the study design detailed in Protocol Addendum
I1F-MC-RHCD(2).
Intervention
The intervention differs per indication and weight of the patient:
patients with moderate psoriasis will enter the 2:1 (ixekizumab vs placebo)
arms. They will receive :
based on the weight of the patients Ixekizumab (20,40 or 80 mg) once every 4
weeks or placebo once every 4 weeks during period 2. All patients will receive
ixekizumab (20,40 or 80 mg) during period 3. In period 4 patients can be
re-randomized to ixekizumab (20,40 or 80 mg) once every 4 weeks or placebo once
every 4 weeks.
patients with severe psoriasis will enter the 2:2:1 (ixekizumab, etanercept or
placebo) arms. They will receive :
based on the weight of the patients Ixekizumab (20,40 or 80 mg) once every 4
weeks, Etanercept (0.8 mg/kg, not exceeding 50 mg per dose) or placebo once
every 4 weeks during period 2. All patients will receive ixekizumab (20,40 or
80 mg) during period 3. In period 4 patients can be re-randomized to ixekizumab
(20,40 or 80 mg) once every 4 weeks or placebo once every 4 weeks.
Study burden and risks
there are several risks involved with Ixekizumab. The most common side effects
are: infections, heart problems, cancer, allergic reactions. For the complete
overview of all side effects of Ixekizumab, please refer to the IB.
There are risks involved with Etanercept, including the risk of infections,
allergic reactions, blood disorders, nerve disorders, signs of heart failure or
wordening of heart failure, signs of cancers and signs of autoimmune
reactions. for the complete overview, please refer to the SPC of Etanercept.
The subject will undergo a number of study procedures which may also be
accompanied by certain risks and finally there may be unknown risks.
Pediatric plaque Ps affects approximately 1% of children and adolescents
globally (Gelfand et al. 2005; Napolitano et al. 2016). It is estimated that
35% to 50% of adults with psoriasis developed their disease before 20 years of
age (De Jager et al. 2009). In a report by Gelfand et al. (2005),
the prevalence of plaque Ps in children in the United Kingdom was 0.55% for
those aged 0 to 9 years and 1.37% for those aged 10 to 19 years. Pediatric
plaque Ps is especially burdensome because it often presents on the face and
scalp, as well as other highly visible areas. Nonbiologic
topical therapies have been the mainstay of treatment due to lack of approved
therapies for plaque Ps in children. Currently, there are few systemic
therapies for pediatric plaque Ps, and most have significant side effects or
are not as effective as desired (Bronckers et al. 2015).
Currently, there is an unmet medical need for effective and safe therapies for
children and adolescents with moderate-to-severe psoriasis
Papendorpseweg 83
Utrecht 3528 BJ
NL
Papendorpseweg 83
Utrecht 3528 BJ
NL
Listed location countries
Age
Inclusion criteria
- Males and females from 6 years to <18 years of age.
- Have a diagnosis of moderate-to-severe plaque-type Ps for at least 6 months prior to baseline (Week 0; Visit 2), as determined by the investigator.
- Have PASI score *12 and a sPGA *3 and body area involved *10% of whole body surface at screening (Visit 1) and baseline (Week 0; Visit 2).
- Are candidates for phototherapy or systemic treatment of Ps (may be either naive or have a prior history of previous treatment) or have Ps considered by the investigator as poorly controlled with topical therapy.
Exclusion criteria
- Pustular, erythrodermic, and/or guttate forms of Ps or have drug induced psoriasis.
- Have used any therapeutic agent targeted at reducing IL-17.
- Previously treated with etanercept (Note: criteria applicable to all countries)
- Concurrent or recent use of any biologic agent within the following washout periods: 1) Adalimumab and infliximab *60 days, abatacept >90 days, anakinra >7 days, or any other biologic DMARD >5 half-lives prior to baseline
- Systemic therapy for Ps and PsA (other than above, eg, MTX, cyclosporine), phototherapy (eg, PUVA) in the previous 4 weeks; 2) Any investigational drugs in the previous 4 weeks or 5 half-lives, whichever is longer; 3) UVA-therapy, UVB-therapy; topical treatments (except in face, scalp, and genital area during screening) in the previous 4 weeks.
- Have latent TB, active TB, acute or chronic viral hepatitis, active infection (within 4 weeks of baseline), history of immune deficiency syndrome, history of malignancy, History of major immunologic reaction, history of sepsis or risk of sepsis.
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 | EUCTR2016-003331-38-NL |
| CCMO | NL60216.091.17 |