A clinical trial evaluating the efficacy and safety of the drugs - cyclosporine and methotrexate in children and adolescents with moderate to severe atopic dermatitis.
- Conditions
- Atopic dermatitisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2020-004194-51-PL
- Lead Sponsor
- Medical University of Lodz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 317
-At the moment of giving written informed consent the patient is between 2-18 y.o.;
-Diagnosis of moderate or severe AD established at least 6 months before baseline. Moderate-to-severe AD (EASI>16, BSA>10, SCORAD>25) must be confirmed based on clinical features on the screening and baseline visits;
-The patient, according to doctor’s opinion is a candidate for systemic therapy;
-Body weight of the participant is within 3 and 97 percentile grid, matched for sex and age;
-Female and male participants may be included. The participants who reached sexual maturity must be willing and give permission to use contraceptives or, together with the parent(s)/legal guardian(s), give a written agreement on sexual abstinence for the whole duration of clinical trial and within 6 months after cessation of IMP. In females with childbearing potential (defined as Tanner stage =3 or menarche), a pregnancy test must be performed at screening and baseline visit to rule out pregnancy. Pregnancy tests will be performed according to schedule (see below for further information);
-The patient can use only topical emollients within 2 weeks before administration of the first study treatment dose;
-The participant, parent(s)/legal guardian(s) are willing and able to comply with scheduled visits, treatment plan, laboratory test and other study procedures;
-The participant, parent(s)/legal guardian(s) give permission to avoid excessive exposure to natural or artificial sunlight (solaria) during the course of clinical trial;
-The medications taken by the participants for other indications than AD must be in stable doses within 2 weeks or 5 half-lives (whichever is longer) prior to the screening visit;
-The participant, parent(s)/legal guardian(s) must be willing and give permission to use only one emollient during the clinical trial, provided by the Sponsor;
-The patient must be vaccinated according to national regulations, the last vaccination at least one month before the first dose of IMP (8 weeks in case of live vaccine).
Are the trial subjects under 18? yes
Number of subjects for this age range: 317
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-The participant suffers from any acute or chronic disease or has abnormal laboratory tests results which could increase the risk of the trial medical intervention and which, according to the Investigator’s opinion, could interfere with the treatment and obscure the interpretation of the results or which make the subject otherwise ineligible to take part in the clinical trial;
-The presence of any psychiatric disorder, alcohol abuse, drug dependency in the participant or in the participant’s parent(s)/legal guardian(s), which in the Investigator’s opinion may make them unable to take part in the clinical trial and to comply with the trial protocol;
-Current clinically significant infection or a history of a clinically significant infection, including herpes simplex infection within 3 months prior to baseline visit 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 and/or a serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication;
-History of any active skin infection within 1 week prior to baseline visit;
-Positive test for HIV;
-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;
-Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level =2.0 times the upper limit of normal (ULN) at screening;
-Immune disorders which may, in the opinion of the Investigator, compromise the safety of the subject in the trial or interfere with evaluation of the IMP;
-Active or latent tuberculosis or improperly treated tuberculosis, proven with QuantiFERON TB Gold test performed on the screening visit or within 12 weeks before the baseline visit. Successful chemoprophylaxis in accordance with local guidelines may enable re-screening;
-Immunosuppressive treatment or use of systemic steroids within 4 weeks before the first dose of IMP;
-Use of phototherapy within 2 weeks prior to baseline visit or PUVA-therapy within 4 weeks prior to baseline visit;
-Use of topical steroids or topical calcineurin inhibitors within two weeks before baseline visit;
-Participation in any other clinical trial involving investigational drug(s) within 8 weeks or within 5 half-lives (if known) whichever is longer prior to clinical trial entry and/or during trial participation;
-Use of MTX or CsA within 6 months prior to baseline visit;
-Known or suspected hypersensitivity to any component of the IMP;
-History of cancer: Subjects who have had any 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;
-Any disorder which is not stable and in the Investigator’s opinion could: affect the safety of the subject throughout the trial, interfere with the evaluation of the IMP or 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, haematological, immun
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method