A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— Flex-Up  

Official title:

A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05507580
• Other study ID #: M22-000
• Secondary ID: 2022-000434-42
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 12, 2023
• Est. completion date: August 9, 2024

Study information

• Verified date: January 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study evaluates the dosing flexibility of upadacitinib in adult participants with moderate to severe AD. Adverse events and change in the disease activity will be assessed.

Upadacitinib is an approved drug for the treatment of moderate to severe/active immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis (UC), Crohn's Disease (CD), and AD. The study is comprised of a 35-day Screening Period, a 12-week double-blind period and a 12-week single-blind period. During the double-blind period, participants are placed in 1 of 2 groups, called treatment arms and will be randomized in a 1:1 ratio to receive upadacitinib. At 12 weeks during the single blind period, participants will be blinded to the upadacitinib dose based on their EASI response and reassigned to in 1 of 4 arms. After the last study visit, there is a 30-day follow-up visit. Approximately 454 adult participants ages 18 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 160 sites worldwide.

The study is comprised of a 12-week double-blind period, followed by a 12-week single-blind period. Participants will receive upadacitinib oral tablets once daily for up to 24 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 461
• Est. completion date: August 9, 2024
• Est. primary completion date: July 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria.

• Eczema Area and Severity Index (EASI) score >= 16, vIGA-AD score >= 3 and >= 10% Body Surface Area (BSA) of AD involvement at the Baseline Visit.

• Baseline weekly average of daily Worst Pruritus NRS >= 4.

• Candidate for systemic treatment defined as prior use of systemic treatment for AD, OR previous inadequate response to TCS, TCI or PDE-4 inhibitors, OR for whom topical treatments are otherwise medically inadvisable.

Exclusion Criteria:

• Participants with current or past history of infection including:

• Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;

• One or more episodes of disseminated herpes simplex (including eczema herpeticum);

• Human immunodeficiency virus (HIV) infection defined as confirmed positive anti-HIV antibody (HIV Ab) test;

• Active tuberculosis (TB) or meet TB exclusionary parameters (protocol specified requirements for TB testing);

• Japan only: Positive result of beta-D-glucan (screening for Pneumocystis jirovecii infection) or two consecutive indeterminate results of beta-D-glucan during the Screening Period;

• Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit;

• Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study;

• COVID-19 infection: In participants who tested positive for COVID, at least 5 days must have passed since a COVID-19 positive test result for study entry of asymptomatic participants. Participants with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Participants may be rescreened if judged to be in good general health, as determined by the investigator based upon the medical history and physical examination.

• Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).

• Any of the following medical diseases or disorders:

• Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery;

• History of an organ transplant which requires continued immunosuppression;

• History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class;

• History of gastrointestinal perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for gastrointestinal perforation per investigator judgment;

• Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; participants with a history of gastric banding/segmentation are not excluded;

• History of malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Upadacitinib
Oral tablet

Locations

Country	Name	City	State
Australia	North Eastern Health Specialists /ID# 246153	Campbelltown	South Australia
Australia	Skin Health Institute Inc /ID# 246146	Carlton	Victoria
Australia	Holdsworth House Medical Practice /ID# 254028	Darlinghurst	New South Wales
Australia	Premier Specialist /ID# 246150	Kogarah	New South Wales
Australia	Veracity Clinical Research /ID# 246154	Woolloongabba	Queensland
Belgium	Grand Hopital de Charleroi /ID# 245837	Charleroi	Hainaut
Belgium	AZ Sint-Lucas /ID# 253708	Gent
Belgium	CHU de Liege /ID# 245839	Liege
Belgium	Dermatologie Maldegem /ID# 245840	Maldegem	Oost-Vlaanderen
Belgium	UCL Saint-Luc /ID# 245842	Woluwe-Saint-Lambert	Bruxelles-Capitale
Bulgaria	Medical center Cordis /ID# 253310	Pleven
Bulgaria	Acibadem City Clinic Tokuda University Hospital EAD /ID# 246395	Sofia
Bulgaria	Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 247027	Sofia
Bulgaria	Medical center EuroHealth /ID# 246305	Sofia
Bulgaria	Medical Center Euroderma /ID# 246736	Sofiya
Bulgaria	UMHAT Alexandrovska EAD /ID# 246594	Sofiya	Sofia
Canada	Beacon Dermatology Inc /ID# 246705	Calgary	Alberta
Canada	Dermatology Research Institute Inc. /ID# 246703	Calgary	Alberta
Canada	Alberta DermaSurgery Centre /ID# 247286	Edmonton	Alberta
Canada	Laser Rejuvenation Clinics Edmonton D.T. Inc. /ID# 256790	Edmonton	Alberta
Canada	Lynderm Research Inc. /ID# 246699	Markham	Ontario
Canada	SKiN Centre for Dermatology /ID# 246702	Peterborough	Ontario
Canada	Dr. Chih-ho Hong Medical Inc. /ID# 246700	Surrey	British Columbia
Canada	Alliance Clinical Trials /ID# 246698	Waterloo	Ontario
China	Beijing Friendship Hospital /ID# 247719	Beijing	Beijing
China	Peking University Third Hospital /ID# 247842	Beijing	Beijing
China	Dermatology Hospital of Southern Medical University /ID# 247951	Guangzhou	Guangdong
China	Huashan Hospital, Fudan University /ID# 247680	Shanghai	Shanghai
China	The First Hospital of China Medical University /ID# 247686	Shenyang	Liaoning
Germany	Fachklinik Bad Bentheim /ID# 245634	Bad Bentheim
Germany	Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 245636	Bramsche
Germany	Elbe Klinikum Buxtehude /ID# 245626	Buxtehude
Germany	Klinikum Darmstadt /ID# 247028	Darmstadt
Germany	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 248413	Dresden
Germany	Universitaetsklinikum Frankfurt /ID# 245627	Frankfurt am Main	Hessen
Germany	Derma Study Center Friedrichshafen GmbH /ID# 245640	Friedrichshafen
Germany	Universitaetsklinikum Halle (Saale) /ID# 245637	Halle (Saale)
Germany	Dermatologikum Hamburg GmbH /ID# 245635	Hamburg
Germany	Dermatologische Gemeinschaftspraxis Mahlow /ID# 245629	Mahlow
Germany	Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 245628	Mainz
Germany	Universitaetsklinikum Muenster /ID# 245623	Muenster	Nordrhein-Westfalen
Hungary	Clinexpert Kft /ID# 246427	Budapest
Hungary	Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 246426	Debrecen
Hungary	Gyongyosi Bugat Pal Korhaz /ID# 246422	Gyongyos	Heves
Hungary	Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246428	Kaposvár	Somogy
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 254355	Ancona
Italy	ASST Spedali civili di Brescia /ID# 246631	Brescia
Italy	Universita degli Studi Gabriele dAnnunzio /ID# 246629	Chieti
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 246634	Milan
Italy	Azienda Ospedaliera di Perugia /ID# 246632	Perugia	Umbria
Italy	Istituto Clinico Humanitas /ID# 246630	Rozzano	Milano
Japan	Fukuoka University Hospital /ID# 255182	Fukuoka-shi	Fukuoka
Japan	Maruyama Dermatology Clinic /ID# 255441	Koto-ku	Tokyo
Japan	Miyata Dermatology Clinic /ID# 255491	Matsudo-Shi	Chiba
Japan	Takagi Dermatological Clinic Branch /ID# 255181	Obihiro-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 255183	Sendai-shi	Miyagi
Japan	Nomura Dermatology Clinic /ID# 255534	Yokohama-shi	Kanagawa
Korea, Republic of	Korea University Ansan Hospital /ID# 245653	Ansan	Gyeonggido
Korea, Republic of	Soonchunhyang University Hospital Bucheon /ID# 245654	Bucheon	Gyeonggido
Korea, Republic of	Chung-Ang University Hospital /ID# 245655	Seoul
Korea, Republic of	KonKuk University Medical Center /ID# 245657	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital /ID# 245651	Seoul
Korea, Republic of	Ajou University Hospital /ID# 245652	Suwon	Gyeonggido
Netherlands	Academisch Medisch Centrum /ID# 245673	Amsterdam
Netherlands	Amphia Ziekenhuis /ID# 246397	Breda
New Zealand	Greenlane Clinical Centre /ID# 246556	Epsom	Auckland
New Zealand	Clinical Trials New Zealand /ID# 246557	Hamilton
New Zealand	Middlemore Hospital /ID# 246559	Otahuhu	Auckland
Poland	OFTALMIKA Sp. z o.o. /ID# 253429	Bydgoszcz
Poland	Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 245741	Gdansk	Pomorskie
Poland	Centrum Medyczne Pratia Gdynia /ID# 245835	Gdynia	Pomorskie
Poland	Silmedic Sp. z o.o. /ID# 253863	Katowice	Slaskie
Poland	CenterMed Krakow Sp. z o.o. /ID# 253940	Krakow	Malopolskie
Poland	Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 245836	Krakow	Malopolskie
Poland	Dermed Centrum Medyczne Sp. z o.o /ID# 246329	Lodz	Lodzkie
Poland	Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 253872	Lodz	Lodzkie
Poland	Specjalistyczna Przychodnia Lekarska Alergo-Med sp. z o.o. /ID# 253846	Poznan	Wielkopolskie
Poland	Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus /ID# 253508	Poznan	Wielkopolskie
Poland	MICS Centrum Medyczne Torun /ID# 245749	Torun	Kujawsko-pomorskie
Poland	Klinika Ambroziak Sp. z o.o. /ID# 245748	Warszawa	Mazowieckie
Poland	Royalderm Agnieszka Nawrocka /ID# 245746	Warszawa	Mazowieckie
Portugal	Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 246247	Lisboa
Portugal	Hospital CUF Descobertas /ID# 245702	Lisboa
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 245704	Porto
Portugal	Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 245701	Porto
Slovakia	BeneDerma s.r.o. /ID# 247513	Bratislava
Slovakia	Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 247515	Bratislava
Slovakia	Univerzitna nemocnica Martin /ID# 246948	Martin
Spain	Hospital General Universitario de Alicante Doctor Balmis /ID# 246270	Alicante
Spain	Hospital Universitario Germans Trias i Pujol /ID# 246320	Badalona	Barcelona
Spain	Hospital Universitario de Bellvitge /ID# 246326	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario Infanta Leonor /ID# 246272	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 246273	Madrid
Spain	Hospital Universitario Puerta de Hierro, Majadahonda /ID# 253820	Majadahonda	Madrid
Spain	Complejo Hospitalario Universitario de Pontevedra /ID# 246323	Pontevedra
Spain	Hospital Universitario Virgen del Rocio /ID# 253822	Sevilla
Taiwan	Kaohsiung Chang Gung Memorial Hospital /ID# 245710	Kaohsiung City	Kaohsiung
Taiwan	Chung Shan Medical University Hospital /ID# 245707	Taichung
Taiwan	Taipei Municipal Wan Fang Hospital /ID# 245712	Taipei
Taiwan	Mackay Memorial Hospital /ID# 245713	Taipei City
Taiwan	National Taiwan University Hospital /ID# 245711	Taipei City
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 245709	Taoyuan City
United Kingdom	NHS Lothian /ID# 246245	Edinburgh
United Kingdom	NHS Greater Glasgow and Clyde /ID# 246253	Glasgow	Scotland
United Kingdom	Leeds Teaching Hospitals NHS Trust /ID# 246241	Leeds
United Kingdom	University Hospital Southampton NHS Foundation Trust /ID# 246393	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Australia,  Belgium,  Bulgaria,  Canada,  China,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Portugal,  Slovakia,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 90	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Week 24
Secondary	Percentage of Participants Achieving EASI 75	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Week 24
Secondary	Percentage of Participants Achieving EASI 100	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Up to Week 24
Secondary	Percentage of Participants Achieving EASI 75	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Week 12
Secondary	Percentage of Participants Achieving EASI 90	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Week 12
Secondary	Percentage of Participants Achieving EASI 100	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Week 12
Secondary	Percentage of Participants Achieving EASI 90 and Worst Pruritus Numerical Rating Scale (NRS) of 0 or 1	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The final EASI score ranges from 0 to 72 where higher scores represent worse disease.; Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours.	Week 12
Secondary	Percentage of Participants Achieving EASI 90 and Worst Pruritus NRS of 0 or 1	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The final EASI score ranges from 0 to 72 where higher scores represent worse disease.; Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours.	Week 24
Secondary	Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1	vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.	Up to Week 24
Secondary	Percentage of Participants Achieving Improvement (reduction) in Worst Pruritus NRS of >= 4	Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours. Higher score denoting worse itch.	Up to Week 24
Secondary	Percentage of Participants Achieving Worst Pruritus NRS of 0 or 1	Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours. Higher score denoting worse itch.	Up to Week 24
Secondary	Percentage of Participants Achieving Improvement (reduction) in Dermatology Life Quality Index (DLQI) of >= 4	DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.	Up to Week 24
Secondary	Percentage of Participants Achieving DLQI of 0 or 1	DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.	Up to Week 24

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