Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

Primary objective: To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo. Maintenance objective: To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.

Key facts

Study ID

NCT03131648

Run by

LEO Pharma

People needed

802

Starts

2017-05-30

Expected to finish

2019-10-10

Last updated by the study team

2025-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent and any locally required authorisation obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
• Age 18 and above.
• Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD (34; Appendix 5).
• Diagnosis of AD for ≥1 year.
• Subjects who have a recent history (within 1 year before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g., due to important side effects or safety risks).
• Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to IGA 0=clear to 2=mild) despite treatment with a daily regimen of TCS of medium to higher potency (±TCI as appropriate), applied for at least 28 days or for the maximum duration recommended by the product prescribing information (e.g., 14 days for super potent TCS), whichever is shorter.
• Subjects with documented systemic treatment for AD in the past year are also considered as inadequate responders to topical treatments and are potentially eligible for treatment with tralokinumab after appropriate washout.
• Important side effects or safety risks are those that outweigh the potential treatment benefits and include intolerance to treatment, hypersensitivity reactions, significant skin atrophy, and systemic effects, as assessed by the investigator or by the subject's treating physician.
• AD involvement of ≥10% body surface area at screening and baseline (visit 3).
• An EASI score of ≥12 at screening and 16 at baseline.
• An IGA score of ≥3 at screening and at baseline.
• A Worst Daily Pruritus numeric rating scale (NRS) average score of ≥4 during the week prior to baseline.
• Worst Daily Pruritus NRS at baseline will be calculated from daily assessments of worst itch severity (Worst Daily Pruritus NRS) during the 7 days immediately preceding randomisation (Day 6 to 0). A minimum of 4 Worst Daily Pruritus NRS scores out of the 7 days is required to calculate the baseline average score. For subjects who do not have at least 4 scores reported during the 7 days immediately preceding the planned randomisation date, randomisation should be postponed until this requirement is met, but without exceeding the 6 weeks maximum duration for screening.
• Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation (refer to exclusion criterion no. 8 for limitations regarding emollients).
• Women of childbearing potential must use a highly effective* form of birth control (confirmed by the investigator) throughout the trial and at least for 16 weeks (5 half lives) after last administration of IMP.
• A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as bilateral tubal occlusion, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), sexual abstinence (when this is in line with the preferred and usual life style of the subject), vasectomised partner (given that the subject is monogamous). The subjects must have used the contraceptive method continuously for at least 1 month prior to the pregnancy test at baseline. A female is defined as not being of child-bearing potential if she is postmenopausal (at least 12 months with no menses without an alternative medical cause prior to screening), or surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy).

You may not qualify if…

• Concurrent enrolment in another clinical trial where the subject is receiving an IMP.
• Previous randomisation in tralokinumab trials.
• Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, or psoriasis.
• Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
• Use of tanning beds or phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), within 6 weeks prior to randomisation.
• Treatment with the following medications within 4 weeks prior to randomisation:
• Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, Janus kinase inhibitors etc.).
• Systemic corticosteroid use (excludes topical, inhaled, or intranasal delivery).
• Three or more bleach baths during any week within the 4 weeks.
• Treatment with the following medications within 2 weeks prior to randomisation
• TCS.
• TCI.
• Topical PDE 4 inhibitor.
• Initiation of treatment of AD with prescription emollients or emollients containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (subjects may continue using stable doses of such emollients if initiated before the screening visit).
• Receipt of live attenuated vaccines 30 days prior to the date of randomisation and during the trial including the safety follow-up period.
• Receipt of inactive/killed vaccinations (e.g. inactive influenza) are allowed, provided they are not administered within 5 days before/after any study visit.
• Receipt of any marketed (i.e. immunoglobulin, anti-IgE) or investigational biologic agent, including dupilumab:
• Any cell-depleting agents including but not limited to rituximab: within 6 months prior to randomisation, or until lymphocyte count returns to normal, whichever is longer.
• Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to randomisation.
• Receipt of any investigational non-biologic agent within 5 half-lives prior to randomisation.
• Receipt of blood products within 4 weeks prior to screening.
• Major surgery within 8 weeks prior to screening, or planned in-patient surgery or hospitalisation during the trial period.
• Known or suspected allergy or reaction to any component of the IMP formulation.
• History of any active skin infection within 1 week prior to randomisation.
• History of a clinically significant infection within 4 weeks prior to randomisation which, in the opinion of the investigator or sponsor's medical expert, may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject's ability to participate in the trial. Clinically significant infections are defined as:

Where it is running

• Tien Q. Nguyen, MD, Inc. — Fountain Valley, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Quest Dermatology Research — Northridge, California, United States
• Dermatology Specialists, Inc. — Oceanside, California, United States
• Center for Dermatology and Laser Surgery — Sacramento, California, United States
• University Clinical Trials, Inc. — San Diego, California, United States
• The GWU Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Skin Care Research, Inc. — Boca Raton, Florida, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• Forward Clinical Trials — Tampa, Florida, United States
• Research Institute of the Southeast, LLC — West Palm Beach, Florida, United States
• ACRC Dermatology — West Palm Beach, Florida, United States
• Georgia Pollens Clinical Research Centers, Inc. — Albany, Georgia, United States
• Allergy Center at Brookstone Research — Columbus, Georgia, United States
• Dermatologic Surgery Specialists — Macon, Georgia, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• Altman Dermatology Associates — Arlington Heights, Illinois, United States
• PMG Research of Christie Clinic — Chicago, Illinois, United States
• Deaconess Clinic — Evansville, Indiana, United States
• Skin Sciences, PLLC — Louisville, Kentucky, United States
• Clinical Trials of SWLA, LLC — Lake Charles, Louisiana, United States
• DermAssociates, PC — Rockville, Maryland, United States
• Clarkston Skin Research — Clarkston, Michigan, United States
• Derm Center — Troy, Michigan, United States
• Clinical Research Center of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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