ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.
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.
1 other identifier
interventional
25
1 country
1
Brief Summary
Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2020
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 6, 2020
CompletedFirst Submitted
Initial submission to the registry
April 13, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedApril 15, 2020
April 1, 2020
9 months
April 13, 2020
April 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Body surface area
evaluation of body surface area percentage affected by psoriasis where 1 palm is equivalent to 1%
16 weeks
Study Arms (1)
Ilumya
EXPERIMENTALIlumya 100mg subcutaneous at weeks 0, 4 and 16.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2020
First Posted
April 15, 2020
Study Start
April 6, 2020
Primary Completion
December 30, 2020
Study Completion
March 1, 2021
Last Updated
April 15, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share