A Multiple Dose Escalation Study of ASKP1240 in Subjects With Moderate to Severe Plaque Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2024
• Main ID: NCT01585233
• Date of registration: 24/04/2012
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Global Development, Inc.
• 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
• Date of first enrolment: April 30, 2012
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01585233
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, New Zealand

Contacts

• Name: Senior Medical Director
• Affiliation: Astellas Pharma Global Development

Key inclusion & exclusion criteria

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.

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Drug: ASKP1240

Drug: Placebo

Primary Outcome(s)

Characterize safety profile of ASKP1240 through adverse event reporting, vital signs, clinical laboratory evaluations, physical examinations and 12-lead electrocardiograms (ECGs) [Time Frame: 113 Days]

Pharmacodynamic variable: CD40 receptor occupancy on peripheral blood B cells [Time Frame: Day 1 to Day 113 (12 visits)]

Pharmacokinetics of ASKP1240: Maximum Concentration (Cmax) [Time Frame: Day 1 to Day 113 (12 visits)]

Pharmacokinetics of ASKP1240: Area under the curve 0-336 (AUC336 ) [Time Frame: Day 1 to Day 113 (12 visits)]

Secondary Outcome(s)

Mean change from baseline to 8 weeks in Physicians Static Global Assessment (PSGA) score [Time Frame: Baseline and 8 weeks]

Anti-ASKP1240 antibodies [Time Frame: Day 1 to Day 113 (8 visits )]

Mean change from baseline to 8 weeks in Psoriasis Area Severity Index (PASI) score [Time Frame: Baseline and 8 weeks]

Cytokine Concentration [Time Frame: Day 1 to Day 113 (9 visits)]

Proportion of Subjects Achieving Treatment Success [Time Frame: 8 weeks]

Lymphocyte subset quantitation [Time Frame: Day 1 to Day 113 (9 visits)]

Mean change from baseline to 8 weeks in % Body Surface Area (BSA) [Time Frame: Baseline and 8 weeks]

Secondary ID(s)

7163-CL-0107

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kyowa Kirin Co., Ltd.