Interstitial Lung Disease MedDRA version: 21.1 Level: LLT Classification code 10066393 Term: Respiratory bronchiolitis-associated interstitial lung disease System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Ofev®
Product Name: Nintedanib 150 mg capsules
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: NINTEDANIB
Other desc
Sponsors
Boehringer Ingelheim España, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Children and adolescents 6 to 17 years old at Visit 2. -Signed and dated written informed consent and assent, where applicable, in accordance with ICH-GCP and local legislation prior to admission to the trial. -Male or female patients. Female of childbearing potential (WOCBP) must confirm that sexual abstinence is standard practice and will be continued until 3 months after last drug intake, or be ready and able to use a highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1% per year when used consistently and correctly, in combination with one barrier method, from 28 days prior to initiation of study treatment, during treatment and until 3 months after last drug intake. Sexual abstinence is defined as abstinence from any sexual act that may result in pregnancy. -Patients with evidence of fibrosing ILD on HRCT within 12 months of Visit 1 as assessed by the investigator and confirmed by central review. -Patients with FVC % predicted =25% at Visit 2. -Patients with clinically significant disease at Visit 2, as assessed by the investigator based on any of the following: Fan score =3, or documented evidence of clinical progression over time based on either a 5-10% relative decline in FVC% predicted accompanied by worsening symptoms, or a =10% relative decline in FVC % predicted, or increased fibrosis on HRCT, or other measures of clinical worsening attributed to progressive lung disease (e.g. increased oxygen requirement, decreased diffusion capacity). Are the trial subjects under 18? yes Number of subjects for this age range: 30 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: AST and/or ALT and/or bilirubin >1.5 x ULN, and/or creatinine clearance <30 mL/min (Schwartz formula), and/or underlying chronic liver disease (Child Pugh A, B or C hepatic impairment) at Visit 1; previous treatment with nintedanib, other investigational therapy received within 1 month or 5 half-lives (whichever is shorter but =1 week) prior to Visit 2; significant pulmonary arterial hypertension, any cardiovascular disease excluded by protocol, history of thrombotic event within 12 months of Visit 1, other disease that may interfere with testing procedures or trial participation, or may put the patient at risk; bleeding risk; life expectancy for any concomitant disease other than ILD <2.5 years (investigator assessment); any diagnosed growth disorder or any genetic disorder associated with short stature and/or treatment with growth hormone therapy within 6 months before Visit 2; <13.5 kg of weight at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing ILD.;Secondary Objective: Not applicable; Primary end point(s): 1) PK: AUCt,ss based on sampling at steady state 2) N (%) of patients with treatment-emergent adverse events ; Timepoint(s) of evaluation of this end point: 1) weeks 2 and 26 2) week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) N (%) of patients with treatment-emergent pathological findings of epiphyseal growth plate on imaging at week 24, and week 52*; 2) N (%) of patients with treatment-emergent pathological findings on dental examination or imaging at week 24, and week 52*; 3) N (%) of patients with treatment-emergent adverse events over the whole trial; 4) Change in height, sitting height, leg length from baseline at week 24, week 52*, week 76*, and week 100*. 5) Change in Forced Vital Capacity (FVC) % predicted from baseline at week 24, and week 52*; 6) Absolute change from baseline in Pediatric Quality of Life Questionnaire™ (PedsQL™) at week 24, and week 52*; 7) Change in oxygen saturation (SpO2) on room air at rest from baseline at week 24, and week 52*; 8) Change in 6-min walk distance from baseline at week 24, and week 52*; 9) Patient acceptability based on the size of capsules at week 24; 10) Patient acceptability based on the number of capsules at week 24; 11) Time to first respiratory-related hospitalization over the whole trial; 12) Time to first acute Interstitial Lung Disease (ILD) exacerbation or death over the whole trial; 13) Time to death over the whole trial; *52 weeks, 76 weeks, 100 weeks time points will not be available for all patients ; Timepoint(s) of evaluation of this end point: 1) weeks 24 and 52 2) weeks 24 and 52 3) end of trial 4) weeks 24, 52, 76, and 100 5) weeks 24 and 52 6) weeks 24 and 52 7) weeks 24 and 52 8) weeks 24 and 52 9) week 24 10) week 24 11) end of trial 12) end of trial | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Russian Federation, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT information disclosure
Boehringer Ingelheim
Outcome results
None listed