Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2)

Phase 3

Completed

Conditions: Atopic Dermatitis

Interventions: Drug: Placebo
Drug: Tralokinumab

Registration Number: NCT03160885

Lead Sponsor: LEO Pharma

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 794

Inclusion Criteria

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 (33; 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).

Exclusion Criteria

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:
- a systemic infection.
- a serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
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.
History of anaphylaxis following any biologic therapy.
History of immune complex disease.
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.
Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care.
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.
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.
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).
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.
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.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0 times the ULN (upper limit of normal) at screening.
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.
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.
Subjects who are legally institutionalised.
Pregnant, breastfeeding, or lactating women.
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.

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maintenance treatment period - Placebo	Placebo	Week 16 to Week 52 Tralokinumab responders from initial treatment period randomised at Week 16 and administered placebo subcutaneous maintenance injection for 36 weeks
Maintenance treatment period - Tralokinumab Q2W	Tralokinumab	Week 16 to Week 52 Tralokinumab responders from the initial treatment period re-randomised at Week 16 and administered tralokinumab maintenance subcutaneous injection regimen Q2W for 36 weeks
Maintenance treatment period - Tralokinumab Q4W	Tralokinumab	Week 16 to Week 52 Tralokinumab responders from the initial treatment period re-randomised at Week 16 and administered tralokinumab maintenance subcutaneous injection regimen Q4W for 36 weeks. Participants in this group receive alternating doses of tralokinumab SC injection and placebo SC injection every 2 weeks
Maintenance treatment period - Tralokinumab Q4W	Placebo	Week 16 to Week 52 Tralokinumab responders from the initial treatment period re-randomised at Week 16 and administered tralokinumab maintenance subcutaneous injection regimen Q4W for 36 weeks. Participants in this group receive alternating doses of tralokinumab SC injection and placebo SC injection every 2 weeks
Initial treatment period - Placebo	Placebo	Week 0 to Week 16 (Initial treatment period): Two subcutaneous (SC) injections of placebo as a loading dose on Day 0 followed by a SC injection of placebo Q2W regimen for 16 weeks
Maintenance treatment period - Placebo (tralokinumab naive)	Placebo	Week 16 to Week 52 Placebo responders from the initial treatment period re-assigned at Week 16 and administered placebo maintenance subcutaneous injection regimen Q2W for 36 weeks
Initial treatment period - Tralokinumab Q2W	Tralokinumab	Week 0 to Week 16 Two subcutaneous (SC) injections of tralokinumab as a loading dose on Day 0, followed by a SC injection of tralokinumab Q2W regimen for 16 weeks
Open-label treatment - Tralokinumab 300 mg Q2W + optional TCS	Tralokinumab	Week 16 to Week 52 Subjects receiving initial treatment with tralokinumab Q2W or placebo Q2W assigned to open-label treatment at Week 16 and administered tralokinumab subcutaneous (SC) injection + optional TCS\* regimen Q2W OR Subjects receiving maintenance treatment with tralokinumab Q2W/Q4W or placebo assigned to open-label treatment after Week 16 and administered tralokinumab SC injection + optional TCS regimen Q2W • TCS = topical corticosteroids

Primary Outcome Measures

Name	Time	Method
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16.	At Week 16	The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI].	At Week 16	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.

Secondary Outcome Measures

Name	Time	Method
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16.	Week 0 to Week 16	The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16.	Week 0 to Week 16	Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16.	Week 0 to Week 16	The DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life (QoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.
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	At Week 52	The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Subjects With at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 52 Among Subjects With EASI75 at Week 16	At Week 52	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Safety and Tolerability: Adverse Event (AE) /Serious Adverse Event (SAE) Frequency	Week 0 to Week 16	Overall summary of AEs and SAEs during the Initial treatment period is presented. For list of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the entire trial period (including safety follow-up), see Adverse Events Overview section.
Subjects Achieving at Least 50% Reduction in Eczema Area and Severity Index [EASI] at Week 16	At Week 16	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Frequency of Anti-drug Antibodies	Week 0 to Week 16	Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method
Subjects Achieving at Least 90% Reduction in Eczema Area and Severity Index [EASI] at Week 16.	At Week 16	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Change From Baseline to Week 16 in Eczema Area and Severity Index [EASI] Score	At Week 16	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Subjects Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16.	At Week 16	The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Subjects Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16.	At Week 16	The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Change From Baseline to Week 16 in Worst Daily Pruritus NRS (Weekly Average).	Baseline to Week 16	Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'
Reduction of Worst Daily Pruritus NRS (Weekly Average) ≥3 From Baseline to Week 16.	Baseline to Week 16	Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of ≥4 Points Among Subjects With Baseline DLQI ≥4.	Baseline to Week 16	The DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their QoL over the last week such as dermatology related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.

Trial Locations

Locations (114): Modern Research Associates, PLLC
🇺🇸
Dallas, Texas, United States
USC Department of Dermatology
🇺🇸
Los Angeles, California, United States
Paddington Testing Company, Inc.
🇺🇸
Philadelphia, Pennsylvania, United States
Island Dermatology
🇺🇸
Newport Beach, California, United States
Yardley Dermatology Associates
🇺🇸
Yardley, Pennsylvania, United States
Pacific Derm
🇨🇦
Vancouver, British Columbia, Canada
Synexus Polska Gdyni
🇵🇱
Gdynia, Poland
Klinika Dermatologii
🇵🇱
Rzeszów, Poland
"DERMED" Centrum Medyczne Sp.
🇵🇱
Łódź, Poland
Chelyabinsk Dermat. Dispensary
🇷🇺
Chelyabinsk, Russian Federation
Military Medical Academy
🇷🇺
Saint Petersburg, Russian Federation
Dermoklinika Centrum Medyczne
🇵🇱
Łódź, Poland
Centrum Medyczne PRATIA
🇵🇱
Kraków, Poland
Psoriasis Treatment Center of Central New Jersey
🇺🇸
East Windsor, New Jersey, United States
Spotlight Research Center, LLC
🇺🇸
Miami, Florida, United States
Dawes-Fretzin Clinical Research Group, LLC
🇺🇸
Indianapolis, Indiana, United States
Harrogate District Hospital
🇬🇧
Harrogate, North Yorkshire, United Kingdom
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
AOU Pisa
🇮🇹
Pisa, Italy
Istituto Clinico Humanitas
🇮🇹
Rozzano, Italy
Bispebjerg Hospital
🇩🇰
Hellerup, Denmark
HFMC New Center One
🇺🇸
Detroit, Michigan, United States
University of Cincinnati Health Physicians Office
🇺🇸
Cincinnati, Ohio, United States
Southern California Dermatology, Inc.
🇺🇸
Santa Ana, California, United States
Olympian Clinical Research
🇺🇸
Clearwater, Florida, United States
Marietta Dermatology Clinical Research, Inc.
🇺🇸
Marietta, Georgia, United States
Private Practice - Dr. Tory P. Sullivan
🇺🇸
North Miami Beach, Florida, United States
Kansas City Dermatology, PA
🇺🇸
Overland Park, Kansas, United States
Clinical Studies Group
🇺🇸
Henderson, Nevada, United States
Corning Center for Clinical Research
🇺🇸
Corning, New York, United States
Rivergate Dermatology Clinical Research Center
🇺🇸
Goodlettsville, Tennessee, United States
Bellaire Dermatology Associates
🇺🇸
Bellaire, Texas, United States
Austin Institute for Clinical Research, Inc.
🇺🇸
Pflugerville, Texas, United States
Burswood Dermatology
🇦🇺
Victoria Park, Western Australia, Australia
Progressive Clinical Research
🇺🇸
San Antonio, Texas, United States
Veracity Clinical Research
🇦🇺
Woolloongabba, Queensland, Australia
Enverus Medical Research
🇨🇦
Surrey, British Columbia, Canada
Winnipeg Clinic
🇨🇦
Winnipeg, Manitoba, Canada
Dr. Chih-ho Hong Medical
🇨🇦
Surrey, British Columbia, Canada
Wiseman Dermatology Research
🇨🇦
Winnipeg, Manitoba, Canada
Brunswick Dermatology Centre
🇨🇦
Fredericton, New Brunswick, Canada
Lynderm Research Inc.
🇨🇦
Markham, Ontario, Canada
Nexus Clinical Research
🇨🇦
St. John's, Newfoundland and Labrador, Canada
Kingsway Clinical Research
🇨🇦
Etobicoke, Ontario, Canada
DermEdge Research
🇨🇦
Mississauga, Ontario, Canada
Guenther Derm Research Centre
🇨🇦
London, Ontario, Canada
Dermatology & Cosmetic Surgery
🇨🇦
Richmond Hill, Ontario, Canada
K. Papp
🇨🇦
Waterloo, Ontario, Canada
Gentofte Hospital
🇩🇰
Hellerup, Denmark
Aarhus University Hospital
🇩🇰
Aarhus, Denmark
XLR8 Medical Research
🇨🇦
Windsor, Ontario, Canada
Spedali Civili Brescia
🇮🇹
Brescia, Italy
Policlinico-Vittorio Emanuele
🇮🇹
Catania, Italy
Policlinico "Agostino Gemelli"
🇮🇹
Rom, Italy
Soon Chun Hyang University Hospital
🇰🇷
Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷
Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷
Seoul, Korea, Republic of
Hallym University Kangnam Sacr
🇰🇷
Seoul, Korea, Republic of
Synexus Polska Katowicach
🇵🇱
Katowice, Poland
Synexus Polska Poznaniu
🇵🇱
Poznań, Poland
Krakowskie Centrum Medyczne
🇵🇱
Kraków, Poland
French clinic of skin diseases
🇷🇺
Saint Petersburg, Russian Federation
Federal State Budgetary Institution State Sci. Ctr.
🇷🇺
Moscow, Russian Federation
Whipps Cross University Hospital
🇬🇧
Leytonstone, London, United Kingdom
Russells Hall Hospital
🇬🇧
Dudley, West Midlands, United Kingdom
Salford Royal Hospital
🇬🇧
Salford, Greater Manchester, United Kingdom
Royal Hallamshire Hospital
🇬🇧
Sheffield, South Yorkshire, United Kingdom
West Suffolk Hospital
🇬🇧
Bury St Edmunds, United Kingdom
The Whittington Hospital NHS
🇬🇧
London, United Kingdom
Derm Clinic of Dr. Robern
🇨🇦
Ottawa, Ontario, Canada
Korea University Ansan Hospital
🇰🇷
Gyeonggi-do, Korea, Republic of
St. Mary's Hospital
🇰🇷
Incheon, Korea, Republic of
Pusan National University Hospital
🇰🇷
Busan, Korea, Republic of
Inha University Hospital
🇰🇷
Incheon, Korea, Republic of
Northwestern University
🇺🇸
Chicago, Illinois, United States
Therapeutics Clinical Research
🇺🇸
San Diego, California, United States
Sadick Dermatology
🇺🇸
New York, New York, United States
Wright State Physicians
🇺🇸
Fairborn, Ohio, United States
California dermatology
🇺🇸
Encinitas, California, United States
Burke Pharmaceutical Research
🇺🇸
Hot Springs, Arkansas, United States
Advanced SkinCare Surgery & Med Center
🇺🇸
Fullerton, California, United States
San Luis Dermatology and Laser Clinic
🇺🇸
San Luis Obispo, California, United States
Thiele Dermatology Specialists, Inc
🇺🇸
Murrieta, California, United States
MedaPhase, Inc.
🇺🇸
Newnan, Georgia, United States
RUSH University
🇺🇸
Chicago, Illinois, United States
Beacon Clinical Research
🇺🇸
Quincy, Massachusetts, United States
Aventiv Research Inc.
🇺🇸
Westerville, Ohio, United States
Skin & Cancer Foundation Australia
🇦🇺
Darlinghurst, New South Wales, Australia
St. George Dermatology and Skin Cancer Center
🇦🇺
Kogarah, New South Wales, Australia
Woden Dermatology Pty Ltd.
🇦🇺
Phillip, Australian Capital Territory, Australia
Eastern Canada Cutaneous Research
🇨🇦
Halifax, Nova Scotia, Canada
Skin Centre for Dermatology
🇨🇦
Peterborough, Ontario, Canada
Chonnam National University Hospital
🇰🇷
Gwangju, Korea, Republic of
IRCCS San Gallicano
🇮🇹
Rom, Italy
Opedale San Salvatore
🇮🇹
L'Aquila, Italy
Chungnam National Univeristy
🇰🇷
Daejeon, Korea, Republic of
Centrum Medyczne Gdynia
🇵🇱
Gdynia, Poland
Yonsei University Health Syste
🇰🇷
Seoul, Korea, Republic of
Ninewells Hospital
🇬🇧
Dundee, Angus, United Kingdom
Royal Victoria Infirmary
🇬🇧
Newcastle upon Tyne, Tyne And Wear, United Kingdom
Walsall Healthcare NHS Trust
🇬🇧
Walsall, West Midlands, United Kingdom
Chapel Allerton Hospital
🇬🇧
Leeds, West Yorkshire, United Kingdom
Dr. David Gratton Dermatologue
🇨🇦
Montréal, Quebec, Canada
CRDQ
🇨🇦
Québec, Quebec, Canada
The Grekin Skin Institute
🇺🇸
Warren, Michigan, United States
Oregon Dermatology and Research Center
🇺🇸
Portland, Oregon, United States
Sinclair Dermatology
🇦🇺
East Melbourne, Victoria, Australia
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Respiratory Medicine Research Institute of Michigan, PLC
🇺🇸
Ypsilanti, Michigan, United States
Skin & Cancer Foundation Inc.
🇦🇺
Carlton, Victoria, Australia
East Surrey Hospital
🇬🇧
Redhill, Surrey, United Kingdom
Clinical Research Center of the Carolinas
🇺🇸
Charleston, South Carolina, United States
Guy's Hospital
🇬🇧
London, United Kingdom

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LEO's Adbry demonstrates long-term efficacy in atopic dermatitis

Leo Pharma's Adbry (tralokinumab-ldrm) shows long-term safety and efficacy in atopic dermatitis, with 92.9% of patients achieving EASI-75 reduction and 66.7% achieving clear or almost clear skin at week 248. Adbry targets IL-13, driving inflammatory processes in atopic dermatitis, and has been FDA-approved since 2021, with expanded use in adolescents in 2023.