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Home » FDA seeks post-start design change in Concert's CF drug trial
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FDA seeks post-start design change in Concert's CF drug trial

Jan. 18, 2017
By Michael Fitzhugh
Concert Pharmaceuticals Inc. said in order to support dose selection for a future phase III trial of CTP-656 in cystic fibrosis (CF), the FDA will require its ongoing phase II trial to institute a washout period during which Kalydeco (ivacaftor, Vertex Pharmaceuticals Inc.) treatment would be withheld – potentially a hard ask for patients meeting the study's screening criteria of having been on at least three months of stable Kalydeco therapy.
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