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ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.

Primary Purpose

Psoriasis

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ilumya Injectable Product
Sponsored by
Psoriasis Treatment Center of Central New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female adult ≥ 18 years of age;

  2. Diagnosis of moderate-to-severe chronic plaque-type psoriasis as defined by

    • BSA 10%
    • PGA ≥3
    • PASI ≥12
  3. Must be a candidate for phototherapy and/or systemic therapy
  4. Females of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.

Exclusion Criteria:

  1. Non-plaque forms of psoriasis
  2. Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating
  3. Presence of significant uncontrolled medical condition that in the opinion of the investigator would affect patient safety during the trial.
  4. Active or untreated latent tuberculosis (TB)

Sites / Locations

  • Psoriasis Treatment Center of Central New JerseyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ilumya

Arm Description

Ilumya 100mg subcutaneous at weeks 0, 4 and 16.

Outcomes

Primary Outcome Measures

Body surface area
evaluation of body surface area percentage affected by psoriasis where 1 palm is equivalent to 1%

Secondary Outcome Measures

Full Information

First Posted
April 13, 2020
Last Updated
April 13, 2020
Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04347473
Brief Title
ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.
Official Title
A Single Center Study to Evaluate the Effectiveness and Safety of ILUMYA in Combination With HALOG Ointment 0.1% for the Treatment of Moderate to Severe Plaque Psoriasis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 6, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
Sun Pharmaceutical Industries Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.
Detailed Description
25 adult subjects with moderate to severe plaque psoriasis will receive Ilumya 100mg subcutaneously at weeks 0, 4 and 16. At week 16, patients with remaining BSA ˃3% will be given HALOG ointment 0.1% to apply BID for 4 weeks. Patients who have ≤3% BSA at week 16 will remain on Ilumya monotherapy. Patients will continue to be evaluated at weeks 20 and 24.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ilumya
Arm Type
Experimental
Arm Description
Ilumya 100mg subcutaneous at weeks 0, 4 and 16.
Intervention Type
Drug
Intervention Name(s)
Ilumya Injectable Product
Intervention Description
IL-23 injection
Primary Outcome Measure Information:
Title
Body surface area
Description
evaluation of body surface area percentage affected by psoriasis where 1 palm is equivalent to 1%
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female adult ≥ 18 years of age; Diagnosis of moderate-to-severe chronic plaque-type psoriasis as defined by BSA 10% PGA ≥3 PASI ≥12 Must be a candidate for phototherapy and/or systemic therapy Females of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide. Exclusion Criteria: Non-plaque forms of psoriasis Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating Presence of significant uncontrolled medical condition that in the opinion of the investigator would affect patient safety during the trial. Active or untreated latent tuberculosis (TB)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jerry Bagel, MD
Phone
6094434500
Email
dreamacres1@aol.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elise Nelson
Phone
6094434500
Email
enelson@windsordermatology.com
Facility Information:
Facility Name
Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise Nelson
Phone
609-443-4500
Ext
1402
Email
enelson@windsordermatology.com
First Name & Middle Initial & Last Name & Degree
Jerry Bagel, MD
First Name & Middle Initial & Last Name & Degree
David Nieves, MD
First Name & Middle Initial & Last Name & Degree
Alexa Hetzel, PA-C
First Name & Middle Initial & Last Name & Degree
Brianna Butler, PA-C
First Name & Middle Initial & Last Name & Degree
Wendy Myers, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.

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