A phase 3 multi-center trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids in children (age 2 to <12 years) and infants (age 6 months to <2 years) with moderate-to-severe atopic dermatitis. The trial is randomized, double blind, placebo-controlled, and parallel-group for children (age 2 to <12 years) and open-label and single-group for infants (age 6 months to <2 years).

Phase 2/3

Recruiting

• Conditions: Treatment of moderate-to-severe Atopic dermatitis

• Registration Number: 2023-503630-44-00
• Lead Sponsor: Leo Pharma A/S

Brief Summary

The primary objective of this trial is to evaluate whether tralokinumab+TCS provides more effective control of the skin manifestations of AD than placebo+TCS in subjects aged 2 to <12 years. In addition, key secondary endpoints are included that address symptom scores and extent of AD, severity of itching or scratching, the impact of AD on the subjects’ quality of life, and the impact of AD on the subjects’ and their caregiver’s daily life and well-being in subjects aged 2 to <12 years. As an exploratory component, this trial will also investigate the impact of tralokinumab+TCS on skin colonization with Staphylococcus aureus and stratum corneum lipid composition (an indirect measure of skin barrier function) in subjects aged 2 to <12 years.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-07
• Last Update Posted: 2025-03-31

Recruitment & Eligibility

• Status: Authorised, recruiting
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

1. Signed and dated informed consent

2. A Child Worst Itch NRS average score* of ≥4 (subjects aged ≥6 years at screening) or a Scratch ObsRO average score* of ≥4 (subjects aged <6 years at screening) during the week prior to baseline. * Average Child Worst Itch NRS and average Scratch ObsRO at baseline will be calculated from daily assessments of each score during the 7 days immediately preceding baseline. Scores must be provided on at least 4 days during the 7 days immediately preceding baseline to calculate the baseline average score. For subjects who do not provide scores on at least 4 days during the 7 days immediately preceding the planned baseline date, randomization or assignment to treatment should be postponed until this requirement is met, but without exceeding the 4 weeks’ maximum duration for screening

3. Subject and caregiver(s) are able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator

4. Female subjects who have been assessed by the investigator to be of childbearing potential (i.e. post-menarcheal and not permanently sterile, see Section 10.3.1 for details) and who are sexually active must agree to use a highly effective* method of contraception to prevent pregnancy during the clinical trial and until 16 weeks (5 half-lives) after discontinuation of treatment with 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 the below (see Section 10.3.2 for details): • Sexual abstinence (when this is in line with the preferred and usual lifestyle of the subject [periodic abstinence, e.g. calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal are not acceptable methods of contraception]). • Bilateral tubal occlusion. • Intrauterine device (IUD). • Intrauterine hormone-releasing system (IUS). • Combined (estrogen 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). • Vasectomized azoospermic partner (given that the subject is monogamous)

5. Age 6 months to <12 years at screening, with the following exceptions for countries outside of North America (US/Canada): • Age 2 years to <12 years at screening in the EU and the UK. • Age 6 years to <12 years at screening in South-Korea.

6. Body weight ≥9 kg at screening

7. Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD (27)

8. History of AD for: • ≥12 months for subjects aged ≥6 years at screening. • ≥3 months for subjects aged 6 months to <6 years at screening

9. Documented inadequate response* to mid-strength** TCS within 6 months before the screening visit. * Inadequate response to topical treatment is defined as either of the below: • Failure to achieve and maintain remission or low disease activity state despite topical AD treatment. • Documented systemic treatment for AD within 6 months before the screening visit. ** Mid-strength TCS is defined as below, see Section 10.4 for details: • Europe: TCS classified as ‘Potent (Class 3)’ or ‘Very potent (Class 4)’. • US: TCS classified as ‘Moderate (Class 4)’, ‘High (Class 2 or 3)’, or ‘Ultra-high (Class 1)’

10. AD involvement of ≥10% body surface area at screening and baseline according to component A of SCORAD

11. An EASI score of ≥16 at screening and baseline

12. An IGA score of ≥3 at screening and baseline

Exclusion Criteria

1.Treatment with the following topical medications within 1 week prior to baseline: • TCS. • TCI. • Topical PDE-4 inhibitor. •Topical JAK inhibitors.

10. Eczema as part of a genodermatosis syndrome, such as Netherton’s syndrome, hyper IgE syndrome, Wiskott–Aldrich syndrome, etc.

11. Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.

12. Clinically significant active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or antiprotozoals within 2 weeks before the baseline visit*. *: If the infection resolves, the screening period may be prolonged after approval by the sponsor's medical expert.

13. History of malignancy at any time before the baseline visit.

14. History of anaphylaxis following any biological therapy.

15. History of immune complex disease.

16. Active or suspected endoparasitic infections (including helminthic infections), or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization. Evaluation will be according to local guidelines as per local standard of care.

17. History of past or current tuberculosis or other mycobacterial infection.

18. History of known HIV infection, confirmed HIV seropositivity at the screening visit, or the subject taking antiretroviral medications as determined by medical history and/or verbal report from the caregiver(s).

19. Established diagnosis of a primary immunodeficiency disorder (e.g. severe combined immunodeficiency, Wiskott–Aldrich syndrome, DiGeorge syndrome, X-linked agammaglobulinemia, common variable immunodeficiency) or secondary immunodeficiency. Subjects suspected to have immunodeficiency based on their clinical presentation (history of invasive opportunistic infections, e.g. tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, chronic mucocutaneous candidiasis, etc. or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the investigator) will also be excluded from the trial.

20. Treatment with bleach baths within 1 week prior to baseline.

21. History of past or current hepatitis B or C including a positive hepatitis B or C test at screening.

22. Known or suspected hypersensitivity to any component of the IMP.

23. Any other medical or psychological condition which in the investigator’s opinion could: • Affect the safety of the subject throughout the trial. • Influence the findings of the trial. • Impede the subject’s ability to complete the trial. Examples include but are not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, immunological, and psychiatric disorders, major physical impairment, drug or alcohol dependency, or unwillingness or lacking ability to understand and comply with the trial related procedures.

24. Pregnant, breastfeeding, or lactating female subjects.

25. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0 times the upper limit of normal (ULN) at screening.

26. Any clinically significant abnormal findings in physical examination, vital signs, hematology, or clinical chemistry during the screening period, which in the opinion of the investigator, may put the subject at risk because of their participation in the trial, may influence the results of the trial, or may affect the subject’s ability to complete the entire duration of the trial.

27. Current participation in any other interventional clinical trial.

28. Previously randomized or assigned to treatment in this clinical trial.

29. Previously randomized in any clinical trials with tralokinumab.

30. Planned major surgical procedure during the subject's participation in this trial.

3.Treatment with the following immunomodulatory medications within 4 weeks prior to baseline: • Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors). • Systemic corticosteroids (excludes inhaled, ophthalmic, or intranasal delivery).

30. Subjects with severe needle phobia or a history of vasovagal reactions following injections or blood withdrawal, or subjects who are unwilling to comply with the assessments of the trial.

31. Inability or unwillingness to receive IMP injections at randomization and throughout the trial.

32. Subjects who are legally institutionalized.

33. Employees at the trial site*, or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals. *: When the trial site is a department at a hospital, this exclusion criterion only applies to family members of employees in the department that participates in the trial.

34. Use of tanning beds or phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen+ultraviolet A [PUVA]) within 4 weeks prior to baseline.

5.Treatment with a live (attenuated) or non-live vaccine within 30 days prior to the baseline visit. Subjects should preferably be brought up-to-date on their vaccinations according to local vaccination programs before being randomized in the trial.

6. Receipt of any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, or dupilumab): • Any cell-depleting agents including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer. • Dupilumab: within 12 weeks prior to baseline. • Other biologics: within 8 weeks or 5 half-lives, whichever is longer, prior to baseline.

7. Treatment with any non-marketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within 3 months or 5 half-lives, whichever is longer, prior to baseline.

8. Receipt of blood products within 4 weeks prior to screening.

9. Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as seborrheic dermatitis, active skin infection, scabies, cutaneous T cell lymphoma, or psoriasis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
IGA 0/1 at Week 16		IGA 0/1 at Week 16
EASI75 at Week 16		EASI75 at Week 16

Secondary Outcome Measures

Name	Time	Method
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.	At week 196	The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening.	At week 196	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).
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.	At week 196	The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Having at least 50% reduction in EASI score in subjects aged 6 month to <2 years at screening.	At week 16	The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Percent change in EASI in subjects aged 6 month to <2 years at screening.	From baseline to week 196	The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening.	From baseline to week 52	The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis. The maximum total score is 103, with higher values indicating more severe disease.
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.	At week 196	The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Having at least 50% reduction in EASI score in subjects aged 2 to <12 years at screening.	At week 16	The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Percent change in EASI in subjects aged 2 to <12 years at screening.	From baseline to week 196	The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening.	From baseline to week 52	The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis. The maximum total score is 103, with higher values indicating more severe disease.
Percent change in affected BSA in subjects aged 2 to <12 years at screening.	From baseline to week 16	BSA is a body surface area.
Percent change in affected BSA in subjects aged 6 month to <2 years at screening.	From baseline to week 16	BSA is a body surface area.
Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening.	From baseline to week 196	The CDLQI 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 various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Reduction in Child Worst Itch numeric rating score (NRS) (weekly average) ≥4 for subjects aged 6 to <12 years at screening.	From baseline to Week 16	The Child Worst Itch NRS assesses 'worst itch today' and 'worst itch last night' using a numerical rating scale from 0 to 10, where 0 represents 'Not itchy at all' and 10 represents 'Very itchy'.
Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 2 to <6 years at screening.	From baseline to week 16	The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 6 months to <2 years years at screening.	From baseline to week 16	The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
Reduction of ≥4 in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening or Scratch ObsRO (weekly average) for subjects aged 2 to <6 years at screening.	From baseline to week 16	The Child Worst Itch NRS assesses 'worst itch today' and 'worst itch last night' using a numerical rating scale from 0 to 10, where 0 represents 'Not itchy at all' and 10 represents 'Very itchy'.; The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 2 to <12 years at screening.	From baseline to week 16	The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 6 month to <2 years at screening.	From baseline to week 16	The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening.	From baseline to week 52	The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening.	From baseline to week 52	The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.	From baseline to week 196	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.
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.	From baseline to week 196	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 in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening.	From baseline to week 16	The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 2 to <6 years at screening.	From baseline to week 16	The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 6 month to <2 years at screening.	From baseline to week 16	The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening.	From baseline to week 52	The CDLQI 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 various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening.	From week 52 to end of treatment	An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening.	From week 52 to end of treatment	An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening.	From week 16 to 52	It measures whether the developed antibodies in response to the treatment have any effect on the safety and effectiveness of the treatment.
Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening.	From week 16 to 52	It measures whether the developed antibodies in response to the treatment have any effect on the safety and effectiveness of the treatment.
Rescue treatment use (yes/no) in subjects aged 2 to <12 years at screening.	From baseline to week 16
Rescue treatment use (yes/no) in subjects aged 6 month to <2 years at screening.	From baseline to week 16
Number of TCS free days in subjects aged 2 to <12 years at screening.	From baseline to week 16	TCS- tropical corticosteroids.
Number of TCS free days in subjects aged 6 month to <2 years at screening.	From baseline to week 16	TCS- tropical corticosteroids.
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.	At week 196	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).
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.	At week 196	The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Percent change in affected body surface area (BSA) in subjects aged 2 to <12 years at screening.	From baseline to week 52
Percent change in affected body surface area (BSA) in subjects aged 6 month to <2 years at screening.	From baseline to week 52
Percent change in Children's Dermatology Life Quality Index (CDLQI) in subjects aged 4 to <12 years at screening.	From baseline to week 52	The CDLQI 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 various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening.	From baseline to week 196	The CDLQI 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 various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.

Trial Locations

Locations (48)

Kozni ambulance Kutna Hora s.r.o.; 🇨🇿 Hlouska, Czechia

Nemocnice AGEL Novy Jicin a.s.; 🇨🇿 Novy Jicin, Czechia

Region Hovedstaden; 🇩🇰 Copenhagen Nv, Denmark

Odense University Hospital; 🇩🇰 Odense C, Denmark

Djecja bolnica Srebrnjak; 🇭🇷 Grad Zagreb, Croatia

Poliklinika Solmed d.o.o.; 🇭🇷 Grad Zagreb, Croatia

Klinika Za Djecje Bolesti Zagreb; 🇭🇷 Grad Zagreb, Croatia

Specijalna Bolnica Medico; 🇭🇷 Rijeka, Croatia

Poliklinika Dermaplus; 🇭🇷 Grad Zagreb, Croatia

Clinical Hospital Centre Rijeka; 🇭🇷 Rijeka, Croatia

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Kozni ambulance Kutna Hora s.r.o.

🇨🇿Hlouska, Czechia

Lucie Petru

Site contact

+420775066427

Petru.L@seznam.cz