RECRUITINGPhase 4INTERVENTIONAL
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.
About This Trial
Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
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)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
DRUG
Ilumya Injectable Product
IL-23 injection
Locations (1)
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States