A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Dermatitis, Atopic, Eczema

In brief

The purpose of this study is to evaluate the effectiveness and safety of 3 dose regimen of CC-93538 in adult participants with moderate to severe Atopic Dermatitis (AD).

Key facts

Study ID

NCT04800315

Run by

Celgene

People needed

221

Starts

2021-05-14

Expected to finish

2022-11-09

Last updated by the study team

2024-01-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must satisfy the following criteria to be enrolled in the study:
• Participant must be ≥ 18 years and ≤ 75 years of age and have a body weight of ≥ 40 kg (88.2 lb) at the time of signing the informed consent form (ICF).
• Participant has chronic atopic dermatitis (AD) as defined by Hanifin and Rajka that has been present for ≥ 1 year prior to the baseline visit (Day 1).
• Participant has moderate to severe, active, and symptomatic AD defined by meeting all of the following criteria on the day of the baseline visit (Day 1):
• Body Surface Area (BSA) ≥ 10%, and
• EASI score ≥ 16, and
• vIGA-AD ≥ 3, and
• Pruritus Numeric Rating Scale (NRS) severity score ≥ 4.
• Participant must have a documented history of inadequate response to treatment with topical medications for at least 4 weeks, unless topical treatments are otherwise medically inadvisable or has required systemic therapy for control of disease.
• Participant must be willing to apply a stable dose of topical emollient (eg, over-the-counter moisturizer, non-medicated emollient, etc.) twice daily for ≥ 7 days prior to the Baseline visit and continue application throughout the study.
• Participant must commit to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
• Participants currently receiving concomitant medications for any reason other than AD, such as inhaled corticosteroids, leukotriene receptor antagonists (eg, montelukast), or mast cell stabilizers (eg, cromolyn sodium) for asthma, must be on a stable regimen, which is defined as not starting a new drug, changing, or stopping dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1 and through the treatment duration of the study.
• Female participants of childbearing potential must agree to practice a highly effective method of contraception.

You may not qualify if…

• The presence of any of the following will exclude a participant from enrollment: Evidence of an active and/or concurrent inflammatory skin condition (eg, seborrheic dermatitis, psoriasis, acute allergic contact dermatitis, etc.) that would interfere with the Investigator or participant-driven evaluations of AD.
• Evidence of acute AD flare between the Screening and Baseline/ Randomization (eg, doubling of the EASI score between Screening and Baseline).
• Use of topical treatments that could affect the assessment of AD (eg, corticosteroids, calcineurin inhibitors, tars, antibiotic creams, topical antihistamines) within 7 days of the Day 1 visit.
• Received phototherapy narrowband UVB (NB-UVB) or broad band phototherapy within 4 weeks prior to the Baseline visit.
• Evidence of immunosuppression, participant is receiving, or has received systemic immunosuppressive or immunomodulating drugs (eg, azathioprine, cyclosporine, systemic corticosteroids, interferon gamma (IFN-γ), Janus kinase inhibitors, methotrexate, mycophenolate-mofetil, etc.) within 4 weeks prior to the Baseline visit.
• Treatment with immunomodulatory biologics
• Concurrent treatment with another IP
• Received a live attenuated vaccine within 1 month prior to the first Screening Visit or anticipates the need to be vaccinated with a live attenuated vaccine during the study.
• Active parasitic/helminthic infection or a suspected parasitic/helminthic infection.
• Ongoing infection
• A history of idiopathic anaphylaxis or a major immunologic reaction (such as anaphylactic reaction, anaphylactoid reaction, or serum sickness) to an immunoglobulin G (IgG) containing agent. A known hypersensitivity to any ingredient in the investigational product (IP) is also exclusionary.

Where it is running

• Local Institution - 119 — Birmingham, Alabama, United States
• Cahaba Dermatology — Birmingham, Alabama, United States
• Local Institution - 114 — Birmingham, Alabama, United States
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Local Institution - 129 — Hot Springs, Arkansas, United States
• First OC Dermatology — Fountain Valley, California, United States
• Local Institution - 105 — Fountain Valley, California, United States
• George Washington University School of Medicine and Health Sciences — Washington D.C., District of Columbia, United States
• Local Institution - 128 — Washington D.C., District of Columbia, United States
• Total Vein and Skin, LLC — Boynton Beach, Florida, United States
• Local Institution - 106 — Delray Beach, Florida, United States
• Palm Beach Dermatology Group — Delray Beach, Florida, United States
• GCP Global Clinical Professionals — St. Petersburg, Florida, United States
• Local Institution - 135 — St. Petersburg, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Local Institution - 101 — Tampa, Florida, United States
• Local Institution - 103 — West Palm Beach, Florida, United States
• Metabolic Research Institute Inc — West Palm Beach, Florida, United States
• Aeroallergy Research Labs of Savannah — Savannah, Georgia, United States
• Local Institution - 134 — Savannah, Georgia, United States
• Local Institution - 108 — Springfield, Illinois, United States
• Sneeze Wheeze and Itch Associates LLC — Springfield, Illinois, United States
• DS Research — Clarksville, Indiana, United States
• Local Institution - 115 — Clarksville, Indiana, United States
• Clinical Research Center of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.