Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

A PHASE 2B RANDOMIZED, DOUBLE‑BLIND, PLACEBO-CONTROLLED, PARALLEL, MULTICENTER, DOSE-RANGING, STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-04965842 IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780167
• Other study ID #: B7451006
• Secondary ID: 2015-005513-72
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.

• Must have the following atopic dermatitis criteria:

1. Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.

2. Have inadequate response to treatment with topical medications given for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) within 12 months of the first dose of study drug.

3. Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the screening and baseline visits).

Exclusion Criteria:

• History of human immunodeficiency virus (HIV) or positive HIV serology at screening,

• Infected with hepatitis B or hepatitis C viruses.

• Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

• Have received any of the following treatment regiments specified in the timeframes outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.

Within 1 week of first dose of study drug: Topical treatments that could affect atopic dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• PF-04965842
10 mg of PF-04965842 QD for 12 weeks
• PF-04965842
30 mg of PF-04965842 QD for 12 weeks
• PF-04965842
100 mg of PF-04965842 QD for 12 weeks
• PF-04965842
200 mg of PF-04965842 QD for 12 weeks
• Placebo
Placebo QD for 12 weeks

Locations

Country	Name	City	State
Australia	The Skin Centre	Benowa	Queensland
Australia	Sinclair Dermatology	East Melbourne	Victoria
Australia	Fremantle Dermatology	Fremantle	Western Australia
Australia	North Eastern Health Specialists	Hectorville, South Australia
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Woden Dermatology	Phillip	Australian Capital Territory
Australia	Australian Clinical Research Network	Sydney	New South Wales
Australia	Veracity Clinical Research	Woolloongabba	Queensland
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Innovaderm Research Inc.	Montreal	Quebec
Canada	Research by ICLS	Oakville	Ontario
Canada	Skin Centre for Dermatology	Peterborough	Ontario
Canada	Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)	Quebec
Canada	The Centre for Dermatology	Richmond Hill	Ontario
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	University of British Columbia	Vancouver	British Columbia
Canada	K. Papp Clinical Research	Waterloo	Ontario
Canada	Windsor Clinical Research Inc	Windsor	Ontario
Canada	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
Germany	ISA GmbH	Berlin
Germany	Universitaetsklinikum Schleswig-Holstein	Luebeck
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Hungary	Bacs Kiskun Megyei Korhaz, Bor es Nemibeteggondozo	Kecskemet
Hungary	CRU Hungary Ltd., MISEK-CRU	Miskolc
Hungary	Szegedi Tudomanyegyetem SzentGyorgyi Albert Klinikai Kozpont Borgyogyaszati es Allergologiai Klinika	Szeged
Hungary	Allergo-Derm Bakos Kft.	Szolnok
United States	Bellaire Dermatology Associates	Bellaire	Texas
United States	Clinical Research Center of Alabama	Birmingham	Alabama
United States	Olympian Clinical Research	Clearwater	Florida
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	University of Connecticut Health Center (UConn Health)	Farmington	Connecticut
United States	Forest Hills Dermatology Group	Forest Hills	New York
United States	DermDox Centers for Dermatology	Hazleton	Pennsylvania
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Dawes Fretzin Dermatology Group, LLC	Indianapolis	Indiana
United States	North Florida Dermatology Associates, PA	Jacksonville	Florida
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Shondra L Smith, MD Dermatology & Advanced Aesthetics	Lake Charles	Louisiana
United States	Clinical Research Consortium	Las Vegas	Nevada
United States	DS Research	Louisville	Kentucky
United States	Sadick Research Group	New York	New York
United States	MedaPhase, Inc.	Newnan	Georgia
United States	Virginia Clinical Research,Inc	Norfolk	Virginia
United States	Park Avenue Dermatology	Orange Park	Florida
United States	Park Avenue Dermatology Administration Annex	Orange Park	Florida
United States	Leavitt Medical Associates of Florida d/b/a Ameriderm Research	Ormond Beach	Florida
United States	Huntington Medical Foundation	Pasadena	California
United States	UPMC Department of Dermatology	Pittsburgh	Pennsylvania
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Health Concepts	Rapid City	South Dakota
United States	West End Dermatology Associates	Richmond	Virginia
United States	Peninsula Research Associates, Inc.	Rolling Hills Estates	California
United States	Emil A. Tanghetti MD dba Center for Dermatology and Laser Surgery	Sacramento	California
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	TCR Medical Corporation	San Diego	California
United States	Clinical Science Institute	Santa Monica	California
United States	Forward Clinical Trials, Inc.	Tampa	Florida
United States	Somerset Skin Centre	Troy	Michigan
United States	Vital Prospects Clinical Research Institute, P.C	Tulsa	Oklahoma
United States	The Dermatology Group, P.C	Verona	New Jersey
United States	Dundee Dermatology	West Dundee	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12	The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).	Baseline and Week 12
Secondary	Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12	The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.	Baseline and Week 12
Secondary	Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12	The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).	Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16.
Secondary	Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points	The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).	Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Secondary	Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.	The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.	Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16
Secondary	Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points	The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).; The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).	Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Secondary	Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points	The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).; The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).	Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Secondary	Time to Achieving >=3 Points Improvement in NRS	The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).; The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).	Baseline till Week 16
Secondary	Time to Achieving >=4 Points Improvement in NRS	The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).; The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).	Baseline till Week 16
Secondary	Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points	The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).; The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).	Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Secondary	Change From Baseline in Pruritus NRS Score at All Scheduled Time Points	The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "worst itching due to AD over the past 24 hours" on a NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).; The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their "frequency of itching due to AD over the past 24 hours" on a NRS anchored by the terms "never/no itching" (0) and "always/constant itching" (10).	Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Secondary	Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points	The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.	All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Secondary	Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points	The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.	All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Secondary	Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points	The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.	All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Secondary	Change From Baseline in Affected BSA at All Scheduled Time Points	BSA Efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA Efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. Since the scalp, palms, and soles are excluded from the BSA (Efficacy) assessment, the maximum possible value is less than 100%.	Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Secondary	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points	SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.	Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Secondary	Percent Change From Baseline in SCORAD at All Scheduled Time Points	SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.	Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Secondary	Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points	SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.	Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Secondary	Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points	SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.	Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Secondary	Number of Participants With Treatment-emergent Adverse Events (AEs)	An AE was any untoward medical occurrence in a subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were events that occurred between the first dose of study drug and the subject's last visit (Week 16) that were absent before treatment or that worsened relative to pretreatment state.	Baseline till Week 16
Secondary	Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)		Baseline up to Week 16
Secondary	Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points	The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the Physician's Global Assessment was used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.	Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Secondary	Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points	The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality.	Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Secondary	Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points	The POEM is a 7-item patient reported outcome (PRO) measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD.	Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Secondary	Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points	The HADS is a 14-item PRO measure used to detect states of anxiety and depression over the past week. The HADS was completed as per schedule of activities. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.	Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16

External Links

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