ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ilumya Injectable Product.
- Who it may be relevant to
- Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
Interventions
- Drug Ilumya Injectable Product
IL-23 injection
Primary outcome measures
- Body surface area [Time frame: 16 weeks]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Psoriasis Treatment Center of Central New Jersey — East Windsor
Identifiers
NCT: NCT04347473 · PTC08