NCT01634087

Brief Summary

This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_2

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

July 2, 2012

Last Update Submit

March 8, 2019

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

  • 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.

    Approximately two months.

  • The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit.

    Approximately 28 days.

Secondary Outcomes (2)

  • Percentage of subjects achieving static Physician's Global Assessment (sPGA) of 1 or 2 at each scheduled visit.

    Day 1, Day 8, Day 15, Day 28 and Day 56 (approximately two months).

  • Preliminary Pharmacokinetic (PK) collections.

    Following 15 days of therapy.

Study Arms (8)

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

Interventions

ItacitinibDRUG

Itacitinib administered orally

Also known as: INCB039110
100 mg QD Itacitinib200 mg BID Itacitinib200 mg QD Itacitinib600 mg once a day Itacitinib
PlaceboDRUG

Placebo administered orally

100 mg QD Placebo200 mg BID Placebo200 mg QD Placebo600 mg once a day Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Hot Springs, Arkansas, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Clinton, Minnesota, United States

Location

Unknown Facility

Fridley, Minnesota, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Moncton, New Brunswick, Canada

Location

Unknown Facility

Windsor, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Québec, Canada

Location

MeSH Terms

Interventions

itacitinibINCB039110

Study Officials

  • Victor Sandor, MD

    Incyte Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2012

First Posted

July 6, 2012

Study Start

June 1, 2012

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

CA(4)US(5)