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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01585233




Registration number
NCT01585233
Ethics application status
Date submitted
24/04/2012
Date registered
25/04/2012
Date last updated
5/03/2024

Titles & IDs
Public title
A Multiple Dose Escalation Study of ASKP1240 in Subjects With Moderate to Severe Plaque Psoriasis
Scientific title
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Sequential, Multiple Dose Escalation Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ASKP1240 in Subjects With Moderate to Severe Plaque Psoriasis
Secondary ID [1] 0 0
7163-CL-0107
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ASKP1240
Treatment: Drugs - Placebo

Experimental: Cohort 1 - ASKP1240 lowest dose

Experimental: Cohort 2 - ASKP1240 low dose

Experimental: Cohort 3 - ASKP1240 high dose

Experimental: Cohort 4 - ASKP1240 highest dose

Placebo Comparator: Placebo -


Treatment: Drugs: ASKP1240
Intravenous

Treatment: Drugs: Placebo
Intravenous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetics of ASKP1240: Area under the curve 0-336 (AUC336 )
Timepoint [1] 0 0
Day 1 to Day 113 (12 visits)
Primary outcome [2] 0 0
Pharmacokinetics of ASKP1240: Maximum Concentration (Cmax)
Timepoint [2] 0 0
Day 1 to Day 113 (12 visits)
Primary outcome [3] 0 0
Pharmacodynamic variable: CD40 receptor occupancy on peripheral blood B cells
Timepoint [3] 0 0
Day 1 to Day 113 (12 visits)
Primary outcome [4] 0 0
Characterize safety profile of ASKP1240 through adverse event reporting, vital signs, clinical laboratory evaluations, physical examinations and 12-lead electrocardiograms (ECGs)
Timepoint [4] 0 0
113 Days
Secondary outcome [1] 0 0
Mean change from baseline to 8 weeks in Psoriasis Area Severity Index (PASI) score
Timepoint [1] 0 0
Baseline and 8 weeks
Secondary outcome [2] 0 0
Mean change from baseline to 8 weeks in Physicians Static Global Assessment (PSGA) score
Timepoint [2] 0 0
Baseline and 8 weeks
Secondary outcome [3] 0 0
Proportion of Subjects Achieving Treatment Success
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Mean change from baseline to 8 weeks in % Body Surface Area (BSA)
Timepoint [4] 0 0
Baseline and 8 weeks
Secondary outcome [5] 0 0
Cytokine Concentration
Timepoint [5] 0 0
Day 1 to Day 113 (9 visits)
Secondary outcome [6] 0 0
Anti-ASKP1240 antibodies
Timepoint [6] 0 0
Day 1 to Day 113 (8 visits )
Secondary outcome [7] 0 0
Lymphocyte subset quantitation
Timepoint [7] 0 0
Day 1 to Day 113 (9 visits)

Eligibility
Key inclusion criteria
- Subject has a clinical diagnosis of moderate to severe plaque psoriasis for 6 months
or longer with at least 5% or greater Body Surface Area (BSA) affected with plaque
psoriasis

- Subject must be a candidate for phototherapy and/or systemic therapy

- Subject must agree to avoid prolonged exposure to the sun and avoid the use of tanning
booths or other ultraviolet light sources during the study

- Female subject must be either:

- post-menopausal (defined as at least 1 year without any menses) prior to
Screening, or

- premenarchal prior to Screening, or

- documented surgically sterile or status post hysterectomy (at least 1 month prior
to Screening), or

- if of childbearing potential, must have a negative serum pregnancy test at Screening
and if sexually active must be using highly effective contraception. All sexually
active subjects will be required to use highly effective contraception consisting of
two forms of birth control (one of which must be a barrier method) starting at
Screening and throughout the study period and for 28 days [or 5 five half lives of the
study drug whichever is longer] after final study drug administration.

- Female subject must not be lactating and must not be breastfeeding at Screening or
during the study period and for 28 days [or 5 five half lives of the study drug
whichever is longer] after final study drug administration.

- Female subject must not donate ova starting at Screening and throughout the study
period and for 28 days [or 5 five half lives of the study drug whichever is longer]
after final study drug administration.

- Male subject and their female spouse/partners who are sexually active must be using
highly effective contraception1 consisting of two forms of birth control (one of which
must be a barrier method) starting at Screening and continue throughout the study
period and for 28 days [or 5 five half lives of the study drug whichever is longer]
after final study drug administration.

- Male subject must not donate sperm starting at Screening and throughout the study
period and for at least 28 days [or 5 five half lives of the study drug whichever is
longer] after final study drug administration.

- Highly effective contraception is defined as:

- Established use of oral, injected or implanted hormonal methods of contraception.

- Placement of an intrauterine device (IUD) or intrauterine system (IUS)

- Barrier methods of contraception: Condom alone or Occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

- Subject must be willing and able to comply with the study requirements, including
prohibited concomitant medication restrictions.

- Waivers to the inclusion criteria will NOT be allowed.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has non-plaque psoriasis (such as guttate, erythrodermic or pustular
psoriasis)

- Subject has received treatment with systemic, non-biologic psoriasis therapy or other
systemic immunosuppressant including investigational use of an approved agent within
the last 30 days or 5 half-lives, whichever is longer, prior to the first dose of
study drug

- Subject has ever been treated with efalizumab (Raptiva®)

- Subject has a total B lymphocyte count by flow cytometric determination that is less
than the lower limit of normal

- Subject has a hemoglobin, that are below the lower limit

- Subject has a total white count, total lymphocyte count, total neutrophil count or
total platelet that are below the lower limit

- Subject has any of the following lab values:

- ALT = 1.5 x upper limit of normal

- AST = 1.5 x upper limit of normal

- Total bilirubin = 1.5 x upper limit of normal

- Subject has previously received ASKP1240 or has participated in a study involving
ASKP1240

- Subject has > 45 body mass index (BMI)

- Subject with a positive Tubercle Bacillus (TB) test who has not previously received
adequate antimicrobial therapy for TB or is currently on, or is planned to start TB
antimicrobial therapy

- Subject has abnormal chest x-ray indicative of acute or chronic lung disease

- Subject has uncontrolled intercurrent illness, including, but not limited to ongoing
or active infection, any clinically significant cardiac disease seizure disorder, or
psychiatric illness/social situations that would limit compliance with study
requirements

- Subject has a history of any malignancy regardless of the location and the time of
diagnosis in the last 5 years (including in-situ carcinoma of the cervix, but
excluding successfully treated non-metastatic basal cell and squamous cell carcinoma)

- Subject has received live or live attenuated virus vaccinations within the last 30
days prior to first dose of study drug

- Subject has received treatment with another investigational drug within 30 days or 5
half-lives; whichever is longer, prior to the initiation of Screening

- Subject has a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C
(HCV) antibody

- Subject has a history of a positive test for human immunodeficiency virus (HIV)
infection

- Subject has received treatment with systemic, biologic psoriasis therapy or other
systemic immunosuppressant including investigational use of an approved agent within
the last 56 days or 5 half-lives whichever is longer, prior to the first dose of study
drug

- Waivers to the exclusion criteria will NOT be allowed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/01/2015
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Specialist Connect - Brisbane
Recruitment hospital [2] 0 0
CMAX - Adelaide
Recruitment hospital [3] 0 0
Epworth Hospital - Richmond
Recruitment hospital [4] 0 0
Linear Research - Nedlands
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3121 - Richmond
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
New Brunswick
Country [2] 0 0
Canada
State/province [2] 0 0
Newfoundland and Labrador
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
New Zealand
State/province [6] 0 0
Christchurch
Country [7] 0 0
New Zealand
State/province [7] 0 0
Tauranga
Country [8] 0 0
New Zealand
State/province [8] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Astellas Pharma Global Development, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Kyowa Kirin Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to explore the safety and tolerability of multiple doses of
ASKP1240 compared to placebo and determine Pharmacokinetics and Pharmacodynamics in subjects
with moderate to severe psoriasis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01585233
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Senior Medical Director
Address 0 0
Astellas Pharma Global Development
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01585233