Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2)
Status: | Active, not recruiting |
---|---|
Conditions: | Psoriasis, Dermatology, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/8/2018 |
Start Date: | June 12, 2017 |
End Date: | August 2019 |
A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
Primary objective:
To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe
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.
To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe
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.
Inclusion Criteria:
- Age 18 and above.
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- Diagnosis of AD for ≥1 year.
- Subjects who have a recent history of inadequate response to treatment with topical
medications or for whom topical treatments are otherwise medically inadvisable.
- AD involvement of ≥10% body surface area at screening and baseline.
- Subjects must have applied a stable dose of emollient twice daily (or more, as needed)
for at least 14 days before randomisation
Exclusion Criteria:
- Active dermatologic conditions that may confound the diagnosis of AD.
- Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
- Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic
corticosteroid within 4 weeks prior to randomisation.
- Treatment with TCS and/or TCI within 2 weeks prior to randomisation.
- Active skin infection within 1 week prior to randomisation.
- Clinically significant infection within 4 weeks prior to randomisation.
- A helminth parasitic infection within 6 months prior to the date informed consent is
obtained.
- Tuberculosis requiring treatment within the 12 months prior to screening.
- Known primary immunodeficiency disorder.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0 times
the ULN (upper limit of normal) at screening.
- Positive hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core
antibody or hepatitis C virus antibody serology at screening.
- History of anaphylaxis following any biologic therapy.
We found this trial at
40
sites
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59 One Mile Road
East Windsor, New Jersey 08520
East Windsor, New Jersey 08520
609-443-4500
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3230 Eden Ave
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
Phone: 513-614-9470
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301 West Bastanchury Road
Fullerton, California 92835
Fullerton, California 92835
Phone: 714-879-9936
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Goodlettsville, Tennessee 37072
Phone: 615-859-7546
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25495 Medical Center Drive
Murrieta, California 92562
Murrieta, California 92562
Phone: 951-304-7546
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1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Phone: 212-241-3288
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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15 Santa Rosa Street
San Luis Obispo, California 93405
San Luis Obispo, California 93405
Phone: 805-541-2650
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Ypsilanti, Michigan 48197
Phone: 734-528-0447
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