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PsoriasisPhase 2NCT01585233

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

A Phase 2 study testing ASKP1240 in people with Psoriasis, run by Astellas Pharma Global Development, Inc. at 13 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psoriasis
What is being tested?
ASKP1240
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
13 sitesin 3 countries
Study dates
30 Apr 2012to 7 Jan 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

Canada5 sites

  • Ultranova Skincare

    Barrie, Ontario, L4M 6L2

  • Durondel C.P. Inc, The Dermatology Clinic

    Moncton, New Brunswick, E1C 8X3

  • Innovaderm Research, Inc.

    Montreal, Quebec, H2K 4L5

  • New Lab Clinical Research

    St. John's, Newfoundland and Labrador, A1C 2H5

  • K. Papp Clinical Research

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Australia4 sites

  • CMAX

    Adelaide, Victoria, 5000

  • Specialist Connect

    Brisbane, Queensland, 4102

  • Linear Research

    Nedlands, Western Australia, 6009

  • Epworth Hospital

    Richmond, Victoria, 3121

Other trials in Australia

New Zealand4 sites

  • Auckland Clinical Studies

    Auckland, 1010

  • Christchurch Clincial Studies Trust, Ltd.

    Christchurch, 8011

  • P3 Research, Tauranga

    Tauranga, 3110

  • P3 Research, Wellington

    Wellington, 6021

Other trials in New Zealand

About this study

Official 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

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.

Read the detailed description

Treatment with ASKP1240 or placebo will be over 4 weeks (Baseline/Day 1, Days 15 and Day 29) with 12 weeks of follow-up for a total of 16 weeks.

Conditions
Psoriasis
Being tested
ASKP1240, Placebo
Keywords
Moderate Psoriasis, Severe Psoriasis, Skin disease, ASKP1240, CD40 antigen, Anti-CD40 monoclonal antibody
Medical subject headings
Psoriasis, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASKP1240Drug

    Intravenous

  • PlaceboDrug

    Intravenous

Study groups in NCT01585233
Study groupRoleWhat they receive
Cohort 1ExperimentalASKP1240 lowest dose
Receives: Drug: ASKP1240
Cohort 2ExperimentalASKP1240 low dose
Receives: Drug: ASKP1240
Cohort 3ExperimentalASKP1240 high dose
Receives: Drug: ASKP1240
Cohort 4ExperimentalASKP1240 highest dose
Receives: Drug: ASKP1240
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics of ASKP1240: Area under the curve 0-336 (AUC336 )

    Measured: Day 1 to Day 113 (12 visits)

  2. Pharmacokinetics of ASKP1240: Maximum Concentration (Cmax)

    Measured: Day 1 to Day 113 (12 visits)

  3. Pharmacodynamic variable: CD40 receptor occupancy on peripheral blood B cells

    Measured: Day 1 to Day 113 (12 visits)

  4. Characterize safety profile of ASKP1240 through adverse event reporting, vital signs, clinical laboratory evaluations, physical examinations and 12-lead electrocardiograms (ECGs)

    Measured: 113 Days

Secondary outcomes (7)

  1. Mean change from baseline to 8 weeks in Psoriasis Area Severity Index (PASI) score

    Measured: Baseline and 8 weeks

  2. Mean change from baseline to 8 weeks in Physicians Static Global Assessment (PSGA) score

    Measured: Baseline and 8 weeks

  3. Proportion of Subjects Achieving Treatment Success

    Success of the treatment of psoriasis is defined as a score of 1 (almost clear) or 0 (clear) as measured by the PSGA

    Measured: 8 weeks

  4. Mean change from baseline to 8 weeks in % Body Surface Area (BSA)

    Measured: Baseline and 8 weeks

  5. Cytokine Concentration

    Measured: Day 1 to Day 113 (9 visits)

  6. Anti-ASKP1240 antibodies

    Measured: Day 1 to Day 113 (8 visits )

  7. Lymphocyte subset quantitation

    Measured: Day 1 to Day 113 (9 visits)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2012 (estimated)
  2. Study start30 Apr 2012
  3. Primary completion30 Jun 2014
  4. Study completion7 Jan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01585233
Sponsor's protocol ID
7163-CL-0107
Status last verified
Nov 2025
First submitted
24 Apr 2012
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASKP1240 in people with Psoriasis, run by Astellas Pharma Global Development, Inc. at 13 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Canada, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics of ASKP1240: Area under the curve 0-336 (AUC336 ) (time frame: Day 1 to Day 113 (12 visits)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01585233.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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