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January 4, 2019updated 12 Jul 2022 1:09pm

Pfizer starts Phase IIb/III trial of PF-06651600 for alopecia areata

Pfizer has commenced a Phase IIb/III clinical trial to evaluate the safety and effectiveness of PF-06651600 for the treatment of patients with moderate to severe alopecia areata.

Pfizer has commenced a Phase IIb/III clinical trial to evaluate the safety and effectiveness of PF-06651600 for the treatment of patients with moderate to severe alopecia areata.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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Alopecia areata is a chronic autoimmune skin disease that results in hair loss on the scalp, face, or body. There is no approved therapy available for the disease.

The randomised, double-blind, dose-ranging trial aims to include adult and adolescent alopecia sufferers with 50% or greater scalp hair loss.

Approximately 660 patients are expected to be enrolled in the study.

“Pfizer has several selective kinase programmes in the clinic with studies spanning across rheumatology, gastrointestinal disorders, and medical dermatology.”

Primary endpoint of the placebo-controlled trial is the percentage of patients achieving an absolute severity of alopecia tool (SALT) score <=10 at week 24.

The trial’s secondary endpoints include percentage of patients achieving a SALT score of <=10 and change from baseline in alopecia areata patient priority outcomes (AAPPO) scale scores.

Pfizer Global product development inflammation and immunology chief development officer Michael Corbo said: “Including our JAK3 programme, Pfizer has several selective kinase programmes in the clinic with studies spanning across rheumatology, gastrointestinal disorders, and medical dermatology, where we aspire to deliver potentially transformative medicines to those living with chronic autoimmune and inflammatory conditions.”

Pfizer’s PF-06651600 is an oral JAK3 inhibitor that received breakthrough therapy designation from the US Food and Drug Administration (FDA) to treat alopecia in September last year.

PF-06651600 is also currently being studied for the treatment of rheumatoid arthritis, Crohn’s disease and ulcerative colitis.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
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