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.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04347473

Enrollment

Registered

2020-04-15

Start date

2020-04-06

Completion date

2021-03-01

Last updated

2020-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

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.

Interventions

DRUGIlumya Injectable Product

IL-23 injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

open label

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Body surface area	16 weeks	evaluation of body surface area percentage affected by psoriasis where 1 palm is equivalent to 1%

Countries

United States

Contacts

Primary ContactJerry Bagel, MD

dreamacres1@aol.com6094434500

Backup ContactElise Nelson

enelson@windsordermatology.com6094434500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026