MEDI8968 in Chronic Obstructive Pulmonary Disease

• Research type

  Research Study

• Full title

  A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease

• IRAS ID

  93264

• Contact name

  Peter MA Calverley

• Sponsor organisation

  MedImmune Ltd

• Eudract number

  2011-002563-23

• Clinicaltrials.gov Identifier

  NCT01448850

• Research summary

  Phase 2, randomized, double-blind, placebo-controlled, multicenter, parallel-group study in adults with symptomatic, moderate-to-very severe COPD (Chronic Obstructive Pulmonary Disease) receiving standard therapy. Approximately 300 adults will be randomized to investigational product every 4 weeks (Q4W) for 52 weeks. Approximately 400 subjects will be screened worldwide. Subjects will be randomized 1:1 ratio to either MEDI8968 or placebo, in addition to standard COPD medication, as follows: - Treatment arm 1: 600 mg intravenous (IV) MEDI8968 followed by 300 mg subcutaneous (SC) MEDI8968 Q4W - Treatment arm 2: IV placebo followed by SC placebo Q4W Week 1 (Day 1), subjects will receive a loading dose of investigational product as a single 600 mg IV infusion over a minimum of 600 mg/hour. Subsequent doses of investigational product will be administered by SC injection Q4W for 52 weeks (total 14 doses incl. loading dose). A consent/screening/run-in period of 17-23 days will precede randomization and investigational product administration. Subjects who have given their informed consent between Days -23 and -17 (Visit 1) will attend a screening visit between Days -22 and -16 (Visit 2) for screening. Subjects meeting eligibility criteria at this visit will enter the 14-day run-in period. At start of the 14-day run-in period (Day -14 [ñ 2 days]/Visit 3), existing maintenance therapy for COPD will be replaced with standard maintenance care therapies (tiotropium alone, budesonide/formoterol 160/4.5 æg, or tiotropium plus budesonide/formoterol 160/4.5 æg) depending on the subject's FEV1 at Visit 2. Subjects may also remain on other COPD medications e.g. mucolytic agents and xanthine-containing derivatises. At Week 1, eligible subjects will be randomized into the 52-week treatment period. Subjects will return to the clinic 8 weeks and 16 weeks after stopping investigational product for follow-up visits. 70-90 subjects will undergo sputum induction procedure to evaluate effect of MEDI8968 on lung inflammation (selected sites only). An external Data Safety Monitoring Board (DSMB) will monitor safety throughout. Subjects will be in the study approximately 72 weeks (up to 23 days consent/screening, 52 weeks treatment, 16 weeks follow-up).

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0069

• Date of REC Opinion

  15 Mar 2012

• REC opinion

  Further Information Favourable Opinion