Atopic dermatitis
Conditions
Interventions
Product Name: Cyclosporin
Pharmaceutical Form: Oral solution
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concent
Sponsors
Medical University of Lodz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of oral cyclosporine (CsA) or methotrexate (MTX) monotherapy compared to standard of care in control of skin manifestations of moderate-to-severe AD in children and adolescents (2-18 y.o.).;Secondary Objective: -To assess the efficacy of MTX or CsA monotherapy compared to standard of care on skin lesions improvement and subjective parameters (itch and quality of sleep) and health-related quality of life; -To assess the safety and tolerability of MTX or CsA compared to standard of care; -To assess the period of clinical remission after treatment cessation at week 32.;Primary end point(s): -Proportion of patients achieving 75% improvement in EASI (EASI75) from baseline at week 32;Timepoint(s) of evaluation of this end point: week 32 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Proportion of patients achieving 75% improvement in EASI (EASI75) from baseline at week 16; -Percent change in EASI score from baseline to week 16; -Percent change in EASI score from baseline to week 32; -Proportion of patients with IGA 0 (clear) or 1 (almost clear) at week 16; -Proportion of patients with IGA 0 (clear) or 1 (almost clear) at week 32; -Change in SCORAD from baseline to week 16; -Change in SCORAD from baseline to week 32; -Itch Reduction of Pruritus in NRS and in VAS from baseline to Week 16; -Itch Reduction of Pruritus in NRS and in VAS from baseline to Week 32; -Change in CDLQI score from baseline to Week 16; -Change in CDLQI score from baseline to Week 32; -Change in FDQL from baseline to week 16; -Change in FDQL from baseline to week 32; -Change in IDQI from baseline to week 16; -Change in IDQI from baseline to week 32; -Change in POEM from baseline to week 16; -Change in POEM from baseline to week 32; -Incidence of treatment-emergent AE from baseline through week 16; -Incidence of treatment-emergent AE from baseline through week 32; -Incidence of treatment-emergent AE leading to treatment discontinuation from baseline through week 16; -Incidence of treatment-emergent AE leading to treatment discontinuation from baseline through week 32.; -Time to exacerbation of AD (loss of at least 50% of the EASI response at week 32) after treatment cessation at week 32.;Timepoint(s) of evaluation of this end point: week 16, week 32 | — |
Countries
Poland
Contacts
Public ContactClinical Trial Unit
Marzena Bielinska
Outcome results
None listed