An exploratory study to investigate the extent to which Dupilumab becomes available to the body as well as Its actions and effects in the liquid found between the skin cells of atopic dermatitis patients

Phase 1

• Conditions: Atopic Dermatitis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-003642-17-AT
• Lead Sponsor: Medical University Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-28
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Male and female atopic dermatitis patients 18 - 65 years of age (both inclusive) at the time of signing informed consent.
2. Chronic atopic dermatitis diagnosed for at least 6 months before enrollment (according to American Academy of Dermatology Consensus Criteria [11] and to the UK Working Party's diagnostic criteria for atopic dermatitis [12])
3. Moderate-to-severe atopic dermatitis (AD) classified as
A) EASI (Eczema Area and Severity Index) [13] score >16 and
B) IGA (Investigator’s global Assessment) ([14]) score =3 and
C) not adequately controlled by topical medication(s).
4. At least one suitable AD lesion that is well accessible for OFM investigation. (A single OFM probe requires a lesion of 35 mm length and 10 mm width; all probes can be placed in one lesion or each OFM probe in an individual lesion.)
5. Subject is able to understand the study requirements, procedures, risks and benefits as outlined in the subject information sheet and informed consent form, is willing and able to comply with the specified requirements and procedures, and has signed the in-formed consent form before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suit-ability for the trial.
6. If subject is female of child-bearing potential, she must have a negative serum beta human chorionic gonadotropin (ß-HCG) pregnancy test performed within 21 days prior to Visit 2 and use an adequate and acceptable method of birth-control during the study.
A female subject is considered of non-childbearing potential if one of the following is reported and documented on the medical history:
? postmenopausal with spontaneous amenorrhea for at least one (1) year, or
? surgical sterilization
7. Subject is available for the entire study duration.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Pregnant and breast feeding women and women unwilling to use reliable contraception during the study, if of child-bearing potential and sexually active
2. Significant allergies to humanized monoclonal antibodies, known hypersensitivity to dupilumab or any of its excipients
3. Clinically significant multiple or severe drug allergies, severe drug-induced hypersensi-tivity reactions (including, but not limited to, erythema multiforme major, linear immuno-globulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis); ac-tive dermatoses in need of systemic treatment
4. History of an ongoing, chronic or recurrent infectious disease, or known tuberculosis infection (both active and previous) as orally stated by the subject; History of Hepatitis B or C or HIV or positive screening serology test for Hepatitis B, C (acute infection) or HIV
5. Alanine transaminase (ALT) >2x upper limit of normal (ULN)
6. Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
7. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice, or cirrhosis.
NOTE: Stable chronic liver disease (including Gilbert’s syndrome, asymptomatic gall-stones) is acceptable if the participant otherwise meets entry criteria
8. Asthma treated with other than inhalator medication (i.e. per oral or Intramuscular anti-asthmatic medication is not allowed)
9. Known helminth infection; Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assess-ments have ruled out active infection
10. Plans for administration of live vaccines during the study period or 4 weeks after last visit or within 12 weeks prior to Visit 2 (dosing).
11. Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 16 weeks or 5 half-lives (whichever is longer) or cell-depleting agents within 6 months before baseline, or until lymphocyte count returns to normal (whichever is longer) prior to dosing
12. Treatment with dupilumab within 16 weeks prior to dosing
13. Immunosuppressive/immunomodulating drugs (systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors, azathioprine, methotrexate) or phototherapy for AD within 4 weeks before Visit 2, or any condition that in the opinion of the investigator, is likely to require such treatments during the first 4 weeks of study treatment
14. Treatment with topical corticosteroids or topical calcineurin inhibitors within 1 week be-fore screening
15. Excessive sun exposure: e.g regular use (more than 2 visits per week) of a tanning booth/parlour within 4 weeks prior to first treatment and during the whole study treat-ment period
16. Treatment with any other medications for AD that could interfere with efficacy out-comes or affect the evaluation for AD severity
17. Uncontrolled systemic disease and ongoing infections (active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to visit 2 or superficial skin infections within 1 week pri-or to the visit 2)
18. Known or suspected history of immunosuppression, including history of invasive oppor-tunistic infections (e.g., tuberculosis, histoplasmosis,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified