Moderate to severe stage of Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 8.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients must have a diagnosis of COPD previously diagnosed by a physician (typical history, physical examination and spirometry) with persistent airway obstruction with FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patients previously treated with ofatumumab 2) Resting transcutaneous oxygen saturation 400 ml increase in FEV1) 4) Patients in long term home oxygen therapy (LTOT) 5) Exacerbation within the last 4 weeks prior to screening 6) Influenza vaccination within the last 4 weeks prior to screening 7) Patient currently participating in a pulmonary rehabilitation course 8) Past or current malignancy within the past 5 years except adequately treated: - Cervical carcinoma Stage 1B or less - Non-invasive basal cell and squamous cell skin carcinoma - Malignant melanoma with a complete response of a duration of > 10 years - Other cancer diagnoses with a complete response of a duration of > 5 years 9) Chronic or current infectious disease such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, sinusitis, and tuberculosis 10) Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities 11) Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease 12)History of significant cerebrovascular disease 13)Known HIV positive 14) Positive serology for hepatitis B, defined as a positive test for HBsAg and/or a combination of a positive test for anti-HBs and anti HBc 15)Screening laboratory values: - WBC 2.5 times the upper limit of normal - ALP > 2.5 times the upper limit of normal - Bilirubin > 1.5 times the upper limit of normal - Creatinine > 1.5 the upper limit of normal. 16) Previous or current atopic disease such as hay fever, asthma, atopic dermatitis 17)Patients who have received treatment with any non-marketed drug substance within 4 weeks prior to Visit 1 (screening) 18) Current participation in any other interventional clinical study 19) Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder) 20) Breast feeding women or women with a positive pregnancy test at Visit 1 21) Women of childbearing potential (Women are considered of childbearing potential unless they have been hysterectomized, have undergone tubal ligation within at least one year prior to Visit 1, or have been postmenopausal for at least one year) not willing to use adequate contraception as hormonal birth control or intrauterine device for the entire trial period during study and one year after last dose of ofatumumab. 22) Allergy to clemastine 23) Allergy to paracetamol 24) Glaucoma (contraindication for clemastine) 25) Problems with urination due to prostatic hyperplasia (contraindication for clemastine) 26) Patients on inhaled steroids and long acting beta2-agonists if not stable dose within 4 weeks prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of ofatumumab in decreasing inflammation in COPD assessed by bronchial biopsies. ;Secondary Objective: To evaluate the safety of ofatumumab in patients with COPD and to describe changes in inflammatory mediators in serum and BAL. To describe objective and subjective changes following treatment with ofatumumab. ;Primary end point(s): Change in inflammation measured as number of inflammatory cells in bronchial biopsies including, but not limited to, CD3+, CD4+, CD8+, CD19+, CD20+, CD68+, elastase, EG2 (eosinophils) and AA1 (mast cells) | — |
Countries
Denmark, United Kingdom
Outcome results
None listed