Clinical trial NCT03160885: Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2017-05-19
Enrollment: 794
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Subjects found eligible following the screening period were randomized 3:1 to initial treatment with tralokinumab 300 mg every 2 weeks (Q2W) or placebo. Randomization was stratified by region (Asia, Australia, Europe, and North America) and disease severity (Investigator's Global Assessment \[IGA\] 3 or 4).

Subjects achieving a clinical response at Week 16 (defined as IGA of 0 or 1 on a 5-point scale ranging from 0 \[clear\] to 4 \[severe\], or at least 75% reduction in Eczema Area and Severity Index \[EASI\] score from baseline \[EASI75\]) continued into maintenance treatment that continued until Week 52.

Subjects randomized to tralokinumab in the initial treatment period and who achieved a clinical response at Week 16 (defined by IGA 0 or 1, or EASI75) were re-randomized 2:2:1 to one of the following Q2W maintenance regimens stratified by region (Asia, Australia, Europe, and North America) and IGA response at Week 16 (IGA 0/1 or IGA \>1):

* Tralokinumab 300 mg Q2W.
* Tralokinumab 300 mg Q4W (alternating dose administrations tralokinumab 300 mg and placebo).
* Placebo.

Subjects randomized to placebo in the initial treatment period who achieved a clinical response at Week 16 (defined by IGA 0 or 1, or EASI75) continued to receive placebo Q2W in the maintenance treatment period.

Subjects not achieving a clinical response at Week 16 as well as those who met the criteria listed below during maintenance treatment were transferred to open-label tralokinumab 300 mg Q2W treatment with optional use of topical corticosteroid (TCS) up to Week 52.

Transfer to open-label treatment during maintenance:

Subjects with IGA=0 at Week 16: IGA of at least 2 and not achieved EASI75 over at least a 4-week period (i.e. over 3 consecutive visits).

Subjects with IGA=1 at Week 16: IGA of at least 3 and not achieved EASI75 over at least a 4-week period (i.e. over 3 consecutive visits).

Subjects with IGA \>1 at Week 16: not achieved EASI75 over at least a 4-week period (i.e. over 3 consecutive visits).

Subjects transferring to open-label treatment had the option to self-administer tralokinumab in their home after adequate training (at 3 dosing visits in the open-label period after additional consent has been obtained) by site staff at the investigator's discretion.

After completion of the maintenance treatment period (or open-label treatment), all subjects, except for those who entered the open-label long-term extension trial, continued in a 14-week off-treatment follow-up period for the assessment of safety and anti-drug antibody (ADA).

Eligibility criteria: Inclusion Criteria:

1. Written informed consent and any locally required authorisation obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
2. Age 18 and above.
3. Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD (33; Appendix 5).
4. Diagnosis of AD for ≥1 year.
5. 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.
6. AD involvement of ≥10% body surface area at screening and baseline (visit 3).
7. An EASI score of ≥12 at screening and 16 at baseline.
8. An IGA score of ≥3 at screening and at baseline.
9. 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.
10. 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).
11. 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).

Exclusion Criteria:

1. Concurrent enrolment in another clinical trial where the subject is receiving an IMP.
2. Previous randomisation in tralokinumab trials.
3. Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, or psoriasis.
4. Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
5. 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.
6. 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.
7. Treatment with the following medications within 2 weeks prior to randomisation

   * TCS.
   * TCI.
   * Topical PDE 4 inhibitor.
8. 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).
9. 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.
10. 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.
11. Receipt of any investigational non-biologic agent within 5 half-lives prior to randomisation.
12. Receipt of blood products within 4 weeks prior to screening.
13. Major surgery within 8 weeks prior to screening, or planned in-patient surgery or hospitalisation during the trial period.
14. Known or suspected allergy or reaction to any component of the IMP formulation.
15. History of any active skin infection within 1 week prior to randomisation.
16. 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:

    * a systemic infection.
    * a serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
17. A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy.
18. History of anaphylaxis following any biologic therapy.
19. History of immune complex disease.
20. History of cancer:

    * Subjects who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained.
    * Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained.
21. Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care.
22. History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications as determined by medical history and/or subject's verbal report.
23. History of chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the investigator.
24. History of attempted suicide or is at significant risk of suicide (either in the opinion of the investigator or defined as a "yes" to suicidal ideation questions no. 4 or 5 or answering "yes" to suicidal behaviour on the Columbia-Suicide Severity Rating Scale \[C-SSRS\] Screening version).
25. Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, psychiatric, or major physical impairment that is not stable, in the opinion of the investigator, and could:

    * Affect the safety of the subject throughout the trial.
    * Influence the findings of the trial or their interpretations.
    * Impede the subject's ability to complete the entire duration of trial.
26. Any clinically significant abnormal findings in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during the screening period, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the trial, or may influence the results of the trial, or the subject's ability to complete entire duration of the trial.
27. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0 times the ULN (upper limit of normal) at screening.
28. Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb) or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb may be randomised provided they are hepatitis B vaccinated and have negative HBsAg and HBcAb.
29. Subjects who are not willing to abstain from donating blood and/or plasma from the time of informed consent and for 16 weeks (5 half-lives) after last dose of IMP.
30. Subjects who are legally institutionalised.
31. Pregnant, breastfeeding, or lactating women.
32. Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals.

Primary outcomes:
measure: Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16.
timeFrame: At Week 16
measure: Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI].
timeFrame: At Week 16
Secondary outcomes:
measure: Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16.
timeFrame: Week 0 to Week 16
measure: Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16.
timeFrame: Week 0 to Week 16
measure: Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16.
timeFrame: Week 0 to Week 16
measure: Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA of 0/1 at Week 16
timeFrame: At Week 52
measure: Subjects With at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 52 Among Subjects With EASI75 at Week 16
timeFrame: At Week 52
measure: Safety and Tolerability: Adverse Event (AE) /Serious Adverse Event (SAE) Frequency
timeFrame: Week 0 to Week 16
measure: Frequency of Anti-drug Antibodies
timeFrame: Week 0 to Week 16
measure: Subjects Achieving at Least 50% Reduction in Eczema Area and Severity Index [EASI] at Week 16
timeFrame: At Week 16
measure: Subjects Achieving at Least 90% Reduction in Eczema Area and Severity Index [EASI] at Week 16.
timeFrame: At Week 16
measure: Change From Baseline to Week 16 in Eczema Area and Severity Index [EASI] Score
timeFrame: At Week 16
measure: Subjects Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16.
timeFrame: At Week 16
measure: Subjects Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16.
timeFrame: At Week 16
measure: Change From Baseline to Week 16 in Worst Daily Pruritus NRS (Weekly Average).
timeFrame: Baseline to Week 16
measure: Reduction of Worst Daily Pruritus NRS (Weekly Average) ≥3 From Baseline to Week 16.
timeFrame: Baseline to Week 16
measure: Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of ≥4 Points Among Subjects With Baseline DLQI ≥4.
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Encinitas
country: United States
facility: California dermatology
state: California
city: Fullerton
country: United States
facility: Advanced SkinCare Surgery & Med Center
state: California
city: Los Angeles
country: United States
facility: USC Department of Dermatology
state: California
city: Murrieta
country: United States
facility: Thiele Dermatology Specialists, Inc
state: California
city: Newport Beach
country: United States
facility: Island Dermatology
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Luis Obispo
country: United States
facility: San Luis Dermatology and Laser Clinic
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: Miami
country: United States
facility: Spotlight Research Center, LLC
state: Florida
city: North Miami Beach
country: United States
facility: Private Practice - Dr. Tory P. Sullivan
state: Florida
city: Marietta
country: United States
facility: Marietta Dermatology Clinical Research, Inc.
state: Georgia
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: RUSH University
state: Illinois
city: Indianapolis
country: United States
facility: Dawes-Fretzin Clinical Research Group, LLC
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology, PA
state: Kansas
city: Quincy
country: United States
facility: Beacon Clinical Research
state: Massachusetts
city: Detroit
country: United States
facility: HFMC New Center One
state: Michigan
city: Warren
country: United States
facility: The Grekin Skin Institute
state: Michigan
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan, PLC
state: Michigan
city: Henderson
country: United States
facility: Clinical Studies Group
state: Nevada
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Corning
country: United States
facility: Corning Center for Clinical Research
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Sadick Dermatology
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Health Physicians Office
state: Ohio
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
city: Westerville
country: United States
facility: Aventiv Research Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Company, Inc.
state: Pennsylvania
city: Yardley
country: United States
facility: Yardley Dermatology Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Goodlettsville
country: United States
facility: Rivergate Dermatology Clinical Research Center
state: Tennessee
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates, PLLC
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Phillip
country: Australia
facility: Woden Dermatology Pty Ltd.
state: Australian Capital Territory
city: Darlinghurst
country: Australia
facility: Skin & Cancer Foundation Australia
state: New South Wales
city: Kogarah
country: Australia
facility: St. George Dermatology and Skin Cancer Center
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Carlton
country: Australia
facility: Skin & Cancer Foundation Inc.
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Victoria Park
country: Australia
facility: Burswood Dermatology
state: Western Australia
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Derm
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Clinic
state: Manitoba
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research
state: Manitoba
city: Fredericton
country: Canada
facility: Brunswick Dermatology Centre
state: New Brunswick
city: St. John's
country: Canada
facility: Nexus Clinical Research
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research
state: Nova Scotia
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: London
country: Canada
facility: Guenther Derm Research Centre
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: North Bay
country: Canada
facility: Dermatology & Cosmetic Surgery
state: Ontario
city: Ottawa
country: Canada
facility: Derm Clinic of Dr. Robern
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: Dermatology & Cosmetic Surgery
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
city: Montréal
country: Canada
facility: Dr. David Gratton Dermatologue
state: Quebec
city: Québec
country: Canada
facility: CRDQ
state: Quebec
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Hellerup
country: Denmark
facility: Bispebjerg Hospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Brescia
country: Italy
facility: Spedali Civili Brescia
city: Catania
country: Italy
facility: Policlinico-Vittorio Emanuele
city: L'Aquila
country: Italy
facility: Opedale San Salvatore
city: Pisa
country: Italy
facility: AOU Pisa
city: Rom
country: Italy
facility: IRCCS San Gallicano
city: Rom
country: Italy
facility: Policlinico "Agostino Gemelli"
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National Univeristy
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Incheon
country: Korea, Republic of
facility: St. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health Syste
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacr
city: Gdynia
country: Poland
facility: Centrum Medyczne Gdynia
city: Gdynia
country: Poland
facility: Synexus Polska Gdyni
city: Katowice
country: Poland
facility: Synexus Polska Katowicach
city: Kraków
country: Poland
facility: Centrum Medyczne PRATIA
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne
city: Poznań
country: Poland
facility: Synexus Polska Poznaniu
city: Rzeszów
country: Poland
facility: Klinika Dermatologii
city: Łódź
country: Poland
facility: "DERMED" Centrum Medyczne Sp.
city: Łódź
country: Poland
facility: Dermoklinika Centrum Medyczne
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Dermat. Dispensary
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution State Sci. Ctr.
city: Saint Petersburg
country: Russian Federation
facility: French clinic of skin diseases
city: Saint Petersburg
country: Russian Federation
facility: Military Medical Academy
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Angus
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
state: Greater Manchester
city: Leytonstone
country: United Kingdom
facility: Whipps Cross University Hospital
state: London
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
state: North Yorkshire
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
city: Redhill
country: United Kingdom
facility: East Surrey Hospital
state: Surrey
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
state: Tyne And Wear
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
state: West Midlands
city: Walsall
country: United Kingdom
facility: Walsall Healthcare NHS Trust
state: West Midlands
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
state: West Yorkshire
city: Bury St Edmunds
country: United Kingdom
facility: West Suffolk Hospital
city: London
country: United Kingdom
facility: The Whittington Hospital NHS
city: London
country: United Kingdom
facility: Guy's Hospital
Study officials:
affiliation: Department of Dermatology, Oregon Health and Science University
name: Eric Simpson, MD, MCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blauvelt A, Gooderham M, Bhatia N, Langley RG, Schneider S, Zoidis J, Kurbasic A, Armstrong A, Silverberg JI. Tralokinumab Efficacy and Safety, with or without Topical Corticosteroids, in North American Adults with Moderate-to-Severe Atopic Dermatitis: A Subanalysis of Phase 3 Trials ECZTRA 1, 2, and 3. Dermatol Ther (Heidelb). 2022 Nov;12(11):2499-2516. doi: 10.1007/s13555-022-00805-y. Epub 2022 Sep 24.
citation: Simpson EL, Merola JF, Silverberg JI, Reich K, Warren RB, Staumont-Salle D, Girolomoni G, Papp K, de Bruin-Weller M, Thyssen JP, Zachariae R, Olsen CK, Wollenberg A. Safety of tralokinumab in adult patients with moderate-to-severe atopic dermatitis: pooled analysis of five randomized, double-blind, placebo-controlled phase II and phase III trials. Br J Dermatol. 2022 Dec;187(6):888-899. doi: 10.1111/bjd.21867. Epub 2022 Oct 26.
citation: Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour JP, Spelman L, Katoh N, Saeki H, Poulin Y, Lesiak A, Kircik L, Cho SH, Herranz P, Cork MJ, Peris K, Steffensen LA, Bang B, Kuznetsova A, Jensen TN, Osterdal ML, Simpson EL; ECZTRA 1 and ECZTRA 2 study investigators. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021 Mar;184(3):437-449. doi: 10.1111/bjd.19574. Epub 2020 Dec 30.