Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
23-358-05 Enrolling

Topical-Intolerant Eczema Research Study (56-59 Weeks)


Treatment: Injection Age: 18 Years


Who Can Participate?

Adults 18-70  with atopic dermatitis (AD) may participate.

Inclusion Criteria

  • Diagnosis of AD for at least 12 months
  • AD present on ≥10% BSA (body surface area)*
  • Have had an inadequate response to topical medications within the past 6 months, or an intolerance to topical therapy
  • Have not been treated with biologics

* 1% of your body surface area is roughly equal to the palm of your hand (no wrists or fingers).

What Are The Benefits?

  • No cost to participate or receive treatment
  • Regular visits with study doctors who specialise in treating AD (19 visits)
  • Will receive a subcutaneous injection of the investigative treatment (study drug) or a placebo
  • Reimbursement for study-related expenses may be provided 

How Long Will The Study Last?

  • 56-59 weeks

Note: Participants may not donate blood for the duration of the study.


Participating Locations

Participating Experts

Dr. Maryam Shayesteh Alam

Dermatologist

Dr. Lorne Albrecht

Dermatologist

Dr. Benjamin Barankin

Dermatologist

Dr. Alim Devani

Dermatologist

Dr. Anatoli Freiman

Dermatologist

Dr. Melinda Gooderham

Dermatologist

Dr. Dathan Hamann

Dermatologist

Dr. Carsten Hamann

Dermatologist

Dr. Sameh Hanna

Dermatologist

Dr. Charles Lynde

Dermatologist

Dr. Vimal Prajapati

Dermatologist

Dr. Mani Raman

Dermatologist

Dr. Michael R. Robern

Dermatologist

Dr. Sheetal Sapra

Dermatologist

Dr. Maxwell Sauder

Dermatologist

Dr. G. Daniel Schachter

Dermatologist

Dr. Shireen Sidhu

Dermatologist

Dr. James Wang

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: June 09, 2024

Official Title

A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled 54-Week Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis

ClinicalTrials.gov ID

NCT06136741

Sponsor

Nektar Therapeutics

Study Description

  • Brief Summary:

    This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis. The estimated duration is 15-35 days for screening and then up to approximately day 378 (last dose on day 280 + 98 days safety follow-up) for all patients. Patients with a response at Week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period.

  • Condition or Disease:

    Moderate to Severe Atopic Dermatitis

  • Intervention/Treatment:

    Drug: Rezpegaldesleukin
    Drug: Rezpegaldesleukin
    Drug: Rezpegaldesleukin
    Drug: Rezpegaldesleukin
    Drug: Rezpegaldesleukin
    Drug: Rezpegaldesleukin
    Drug: Rezpegaldesleukin
    Drug: Rezpegaldesleukin
    Drug: Rezpegaldesleukin
    Drug: Placebo
    Drug: Placebo
    Drug: Rezpegaldesleukin
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 70 Years (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Adults (18 to 70 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer prior to screening.

AD disease severity at screening and randomization:

EASI of 16 or higher
IGA of 3 or 4
BSA of 10% or more
Documented history, within 6 months prior to the screening visit, of either inadequate response or inadvisability of topical treatments.
Able to complete patient questionnaires.
Able and willing to comply with requested study visits and procedures.
Able and willing to provide written informed consent.

Exclusion Criteria:

Prior use of systemic immune modulating therapies for AD (i.e., JAK inhibitors or biologics)
Other skin conditions that would interfere with assessment of AD
Treatment with a live (attenuated) immunization within 12 weeks prior to screening.
Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.
Any malignancies or history of malignancies within 5 years prior to randomization (except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years or cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to randomization).
Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening.
Severe concomitant illness that would in the Investigator’s opinion inhibit the patient’s participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease.
Concurrent participation in any other investigational clinical study.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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