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NCT Number: NCT04347473

ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.

Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location status: Recruiting

Location contact

Alexa Hetzel, PA-C

SUB_INVESTIGATOR

Brianna Butler, PA-C

SUB_INVESTIGATOR

David Nieves, MD

SUB_INVESTIGATOR

Elise Nelson

CONTACT

[email protected]

609-443-4500 ext. 1402

Jerry Bagel, MD

PRINCIPAL_INVESTIGATOR

Wendy Myers, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ilumya Injectable Product

Drug

IL-23 injection

Primary outcomes

  1. Body surface area

    Time frame: 16 weeks

    evaluation of body surface area percentage affected by psoriasis where 1 palm is equivalent to 1%

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Nelson

CONTACT

[email protected]

6094434500

Jerry Bagel, MD

CONTACT

[email protected]

6094434500

Sponsors and collaborators

Lead sponsor

Psoriasis Treatment Center of Central New Jersey

Other

Collaborators

  • Sun Pharmaceutical Industries Limited

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 15, 2020
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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