Plaque PsoriasisPhase 2NCT01634087
A Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis
A Phase 2 study testing Itacitinib in people with Plaque Psoriasis, run by Incyte Corporation at 9 sites in 2 countries.
Trial summary
This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Itacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jun 2012to Feb 2013
- 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
- Subjects with chronic plaque psoriasis aged 18 to 75 who have had insufficient response to topical agents, and who meet the psoriasis assessment expectations as defined in the study protocol
Who cannot join
- Females who are pregnant or breastfeeding
- Men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively
- Subjects treated with leflunomide or other biological therapies to treat psoriasis and all JAK-STAT inhibitors within 12 weeks prior to first dose of study drug
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States5 sites
Study site
Clinton, Minnesota
Study site
Fridley, Minnesota
Study site
Hot Springs, Arkansas
Study site
Los Angeles, California
Study site
Rochester, New York
Canada4 sites
Study site
Moncton, New Brunswick
Study site
Montreal, Quebec
Study site
Québec
Study site
Windsor, Ontario
About this study
Official title: A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of Escalating Doses of Oral Itacitinib in Subjects With Stable, Chronic Plaque Psoriasis
This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib.
- Conditions
- Plaque Psoriasis
- Being tested
- Itacitinib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItacitinibDrug
Also called INCB039110
Itacitinib administered orally
PlaceboDrug
Placebo administered orally
| Study group | Role | What they receive |
|---|---|---|
| 100 mg QD Itacitinib | Experimental | Not described Receives: Drug: Itacitinib |
| 100 mg QD Placebo | Experimental | Not described Receives: Drug: Placebo |
| 200 mg QD Itacitinib | Experimental | Not described Receives: Drug: Itacitinib |
| 200 mg QD Placebo | Experimental | Not described Receives: Drug: Placebo |
| 200 mg BID Itacitinib | Experimental | Not described Receives: Drug: Itacitinib |
| 200 mg BID Placebo | Experimental | Not described Receives: Drug: Placebo |
| 600 mg once a day Itacitinib | Experimental | Not described Receives: Drug: Itacitinib |
| 600 mg once a day Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of itacitinib as measured by changes in frequency and severity of adverse events, ECGs, physical examination, vital signs, and clinical laboratory evaluations.
Measured: Approximately two months.
The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit.
Measured: Approximately 28 days.
Secondary outcomes (2)
Percentage of subjects achieving static Physician's Global Assessment (sPGA) of 1 or 2 at each scheduled visit.
Measured: Day 1, Day 8, Day 15, Day 28 and Day 56 (approximately two months).
Preliminary Pharmacokinetic (PK) collections.
Plasma concentrations of itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).
Measured: Following 15 days of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victor Sandor, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634087
- Sponsor's protocol ID
- INCB 39110-250
- Status last verified
- Mar 2019
- First submitted
- 2 Jul 2012
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of Escalating Doses of Oral Itacitinib in Subjects With Stable, Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01634087
- Acronym / sponsor ID
- INCB 39110-250
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 6 Jul 2012 (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.
This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 100 mg QD Itacitinib | Experimental | Drug: Itacitinib |
| 100 mg QD Placebo | Experimental | Drug: Placebo |
| 200 mg QD Itacitinib | Experimental | Drug: Itacitinib |
| 200 mg QD Placebo | Experimental | Drug: Placebo |
| 200 mg BID Itacitinib | Experimental | Drug: Itacitinib |
| 200 mg BID Placebo | Experimental | Drug: Placebo |
| 600 mg once a day Itacitinib | Experimental | Drug: Itacitinib |
| 600 mg once a day Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with chronic plaque psoriasis aged 18 to 75 who have had insufficient response to topical agents, and who meet the psoriasis assessment expectations as defined in the study protocol
Key exclusion criteria (3 listed)
- Females who are pregnant or breastfeeding
- Men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively
- Subjects treated with leflunomide or other biological therapies to treat psoriasis and all JAK-STAT inhibitors within 12 weeks prior to first dose of study drug
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 |
|---|---|---|
| ItacitinibAlso: INCB039110Itacitinib administered orally | Drug | 100 mg QD Itacitinib, 200 mg BID Itacitinib, 200 mg QD Itacitinib, 600 mg once a day Itacitinib |
| PlaceboPlacebo administered orally | Drug | 100 mg QD Placebo, 200 mg BID Placebo, 200 mg QD Placebo, 600 mg once a day Placebo |
Primary outcome
Safety and tolerability of itacitinib as measured by changes in frequency and severity of adverse events, ECGs, physical examination, vital signs, and clinical laboratory evaluations.
Time frame: Approximately two months.
The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit.
Time frame: Approximately 28 days.
2 secondary outcomes
Percentage of subjects achieving static Physician's Global Assessment (sPGA) of 1 or 2 at each scheduled visit.
Time frame: Day 1, Day 8, Day 15, Day 28 and Day 56 (approximately two months).
Preliminary Pharmacokinetic (PK) collections.
Time frame: Following 15 days of therapy.
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 12 Mar 2019.
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A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
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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.
Victor Sandor, MD study director
Incyte Corporation
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itacitinib in people with Plaque Psoriasis, run by Incyte Corporation at 9 sites in 2 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 1 inclusion and 3 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 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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. 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?
Safety and tolerability of itacitinib as measured by changes in frequency and severity of adverse events, ECGs, physical examination, vital signs, and clinical laboratory evaluations. (time frame: Approximately two months.). 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?
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 12 Mar 2019.