Treatment for moderate-to-severe plaque psoriasis using Ilumya and Halog ointment

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.

This study is testing if using Ilumya injections along with Halog ointment can help adults with moderate to severe plaque psoriasis feel better.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Psoriasis Treatment Center of Central New Jersey (Academic / other)
• Locations: 1 site (East Windsor, New Jersey)
• Trial ID: NCT04347473 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Ilumya, an injectable treatment, in combination with Halog ointment for patients with moderate to severe plaque psoriasis. A total of 25 adult participants will receive Ilumya subcutaneously at specified intervals, and those with a body surface area (BSA) greater than 3% at week 16 will also apply Halog ointment for four weeks. The study aims to assess the outcomes at weeks 20 and 24 to determine the efficacy of this combination therapy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of moderate to severe chronic plaque psoriasis.

Not a fit: Patients with non-plaque forms of psoriasis or those who are pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve skin clearance and quality of life for patients suffering from moderate to severe plaque psoriasis.

How similar studies have performed: Previous studies have shown promising results with similar combination therapies for psoriasis, indicating potential for success in this approach.

Eligibility criteria

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)

Where this trial is running

East Windsor, New Jersey

• Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States (Recruiting)

Study contacts

• Study coordinator: Jerry Bagel, MD

Conditions Psoriasis