PsoriasisPhase 2NCT01096862
A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Psoriasis
A Phase 2 study testing peficitinib in people with Psoriasis, run by Astellas Pharma Inc at 11 sites in United States.
Trial summary
The purpose of this study is to explore the efficacy and safety of multiple, escalating doses of ASP015K when compared to placebo in subjects with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- peficitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 11 sitesUnited States
- Study dates
- 23 Mar 2010to 27 Jul 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has moderate to severe plaque psoriasis for 6 months or longer with at least 10% Body Surface Area (BSA) affected
- Subject must be a candidate for phototherapy and/or systemic therapy
Who cannot join
- Subject has non-plaque psoriasis or drug-induced psoriasis
- Subject is on systemic psoriasis therapy within 56 days or 5 half-lives, whichever is longer, prior to first dose of study drug
- Subject has a positive TB skin test within 3 months of screening or at screening
- Subject has an abnormal chest x-ray
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, 35205
J & S Studies
College Station, Texas, 77845
Rivergate Dermatology
Goodlettsville, Tennessee, 37072
Palmetto Clinical Trial Services
Greenville, South Carolina, 29607
Derm Research, PLLC
Louisville, Kentucky, 40217
Madison Skin & Research, Inc
Madison, Wisconsin, 53719
FXM Research, Corp.
Miami, Florida, 33175
Virginia Clinical Research
Norfolk, Virginia, 23507
Renstar Medical Research
Ocala, Florida, 34471
Oregon Medical Research Center
Portland, Oregon, 97223
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Sequential Group, Multiple-Dose Escalation Study to Evaluate the Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Plaque Psoriasis
The purpose of this study is to explore the efficacy and safety of multiple, escalating doses of ASP015K when compared to placebo in subjects with moderate to severe plaque psoriasis.
Read the detailed description
Following completion of at least 1 week of study drug for all subjects in group 1, the Sponsor will review the safety information of these subjects prior to enrolling off-treatment subjects into the next dose group. Dose escalation will continue in this manner (unless stopping criteria are met) until all groups have completed the study.
- Conditions
- Psoriasis
- Being tested
- peficitinib, Placebo
- Keywords
- ASP015K, Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peficitinibDrug
Also called ASP015K
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | lowest dose Receives: Drug: peficitinib |
| Group 2 | Experimental | low dose Receives: Drug: peficitinib |
| Group 3 | Experimental | high dose Receives: Drug: peficitinib |
| Group 4 | Experimental | highest dose Receives: Drug: peficitinib |
| Group 5 | Experimental | medium dose Receives: Drug: peficitinib |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score
Measured: 6 weeks
Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Measured: 6 weeks
Secondary outcomes (3)
Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA)
Measured: 6 weeks
Change from baseline to end of treatment in percent body surface area (BSA)
Measured: 6 weeks
Success of the treatment of psoriasis as measured by a Physician's Static Global Assessment (PSGA) of Almost Clear or Clear
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study start23 Mar 2010
- Primary completion27 Jul 2011
- Study completion27 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096862
- Sponsor's protocol ID
- 015K-CL-PS01
- Status last verified
- Oct 2024
- First submitted
- 18 Mar 2010
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Papp K, Pariser D, Catlin M, Wierz G, Ball G, Akinlade B, Zeiher B, Krueger JG. A phase 2a randomized, double-blind, placebo-controlled, sequential dose-escalation study to evaluate the efficacy and safety of ASP015K, a novel Janus kinase inhibitor, in patients with moderate-to-severe psoriasis. Br J Dermatol. 2015 Sep;173(3):767-76. doi: 10.1111/bjd.13745. Epub 2015 Jun 19.
PubMed 25704750
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Sequential Group, Multiple-Dose Escalation Study to Evaluate the Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01096862
- Acronym / sponsor ID
- 015K-CL-PS01
- Conditions
- Psoriasis
- Keywords
- ASP015K, Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2010 (actual)
- Primary completion
- 27 Jul 2011 (actual)
- Study completion
- 27 Jul 2011 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the efficacy and safety of multiple, escalating doses of ASP015K when compared to placebo in subjects with moderate to severe plaque psoriasis.
Detailed description
Following completion of at least 1 week of study drug for all subjects in group 1, the Sponsor will review the safety information of these subjects prior to enrolling off-treatment subjects into the next dose group. Dose escalation will continue in this manner (unless stopping criteria are met) until all groups have completed the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: peficitiniblowest dose |
| Group 2 | Experimental | Drug: peficitiniblow dose |
| Group 3 | Experimental | Drug: peficitinibhigh dose |
| Group 4 | Experimental | Drug: peficitinibhighest dose |
| Group 5 | Experimental | Drug: peficitinibmedium dose |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has moderate to severe plaque psoriasis for 6 months or longer with at least 10% Body Surface Area (BSA) affected
- Subject must be a candidate for phototherapy and/or systemic therapy
Key exclusion criteria (4 listed)
- Subject has non-plaque psoriasis or drug-induced psoriasis
- Subject is on systemic psoriasis therapy within 56 days or 5 half-lives, whichever is longer, prior to first dose of study drug
- Subject has a positive TB skin test within 3 months of screening or at screening
- Subject has an abnormal chest x-ray
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peficitinibAlso: ASP015Koral | Drug | Group 1, Group 2, Group 3, Group 4, Group 5 |
| Placebooral | Drug | Placebo |
Primary outcome
Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score
Time frame: 6 weeks
Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Time frame: 6 weeks
3 secondary outcomes
Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA)
Time frame: 6 weeks
Change from baseline to end of treatment in percent body surface area (BSA)
Time frame: 6 weeks
Success of the treatment of psoriasis as measured by a Physician's Static Global Assessment (PSGA) of Almost Clear or Clear
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Derived from this study: PubMed 25704750Papp K, Pariser D, Catlin M, Wierz G, Ball G, Akinlade B, Zeiher B, Krueger JG. A phase 2a randomized, double-blind, placebo-controlled, sequential dose-escalation study to evaluate the efficacy and safety of ASP015K, a novel Janus kinase inhibitor, in patients with moderate-to-severe psoriasis. Br J Dermatol. 2015 Sep;173(3):767-76. doi: 10.1111/bjd.13745. Epub 2015 Jun 19.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Global Development
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing peficitinib in people with Psoriasis, run by Astellas Pharma Inc at 11 sites in United States.
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 2 inclusion and 4 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score (time frame: 6 weeks). The study lists 2 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 NCT01096862, which also lists 1 linked publication.
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 21 Oct 2024.