A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

Hidradenitis Suppurativa Clinical Trial

— Step-Up HS  

Official title:

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889182
• Other study ID #: M23-698
• Status: Recruiting
• Phase: Phase 3
• Start date: June 21, 2023
• Est. completion date: August 1, 2027

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This study will assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of HS. This study is "double-blinded", meaning that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo. This study is comprised of 3 periods. In Period 1, participants are randomized into 2 groups called treatment arms where each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In Period 2, participants are placed into 6 different groups depending on their placement and results in Period 1. Period 3 is the long-term extension period where participants will continue treatment from Period 2. Approximately 1328 adult and adolescent participants diagnosed with HS will be enrolled in approximately 275 sites worldwide. Participants will receive oral tablets of upadacitinib or placebo once daily for 36 weeks in Period 1 and Period 2. Eligible participants from Period 1 and Period 2 will enter Period 3 and receive oral tablets of upadacitinib or placebo once daily for 68 weeks. Participants will be followed up for approximately 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1328
• Est. completion date: August 1, 2027
• Est. primary completion date: November 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of HS for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of subject).
• Documented history of previous use of = 1 TNF inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator.
• Participant must have a total AN count of = 5 at Baseline.
• HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
• At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
• Draining fistula count of = 20 at Baseline.

Exclusion Criteria:

• History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
• Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study. Investigational drugs are also prohibited during the study.
• Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level.
• Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit.
• Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• Upadacitinib
Oral Tablets
• Placebo
Oral Tablets

Locations

Country	Name	City	State
Australia	Skin Health Institute Inc /ID# 254416	Carlton	Victoria
Australia	Holdsworth House Medical Practice /ID# 254411	Darlinghurst	New South Wales
Australia	Sinclair Dermatology - Melbourne /ID# 254412	East Melbourne	Victoria
Australia	Alfred Hospital /ID# 254414	Melbourne	Victoria
Australia	Paratus Clinical Research Woden /ID# 254670	Phillip	Australian Capital Territory
Austria	Medizinische Universitaet Graz /ID# 253448	Graz	Steiermark
Austria	Ordensklinikum Linz GmbH Elisabethinen /ID# 253458	Linz	Oberoesterreich
Austria	Medizinische Universitaet Wien /ID# 254096	Vienna	Wien
Belgium	Universite Libre de Bruxelles - Hopital Erasme /ID# 254082	Anderlecht	Bruxelles-Capitale
Belgium	Grand Hopital de Charleroi /ID# 254091	Charleroi	Hainaut
Belgium	UZ Gent /ID# 254090	Gent	Oost-Vlaanderen
Belgium	Universitair Ziekenhuis Leuven /ID# 254089	Leuven	Vlaams-Brabant
Brazil	Hospital Moinhos de Vento /ID# 254366	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 254367	Ribeirão Preto	Sao Paulo
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 254370	Sao Paulo
Brazil	Centro de Desenvolvimento em Estudos Clínicos Brasil - CDEC /ID# 254368	São Paulo	Sao Paulo
Bulgaria	Acibadem City Clinic Tokuda University Hospital EAD /ID# 253331	Sofia
Bulgaria	Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 253329	Sofia
Bulgaria	Diagnostic consultative center Focus-5 /ID# 253327	Sofiya
Bulgaria	UMHAT Professor Stoyan Kirkovich /ID# 253328	Stara Zagora
Canada	Beacon Dermatology Inc /ID# 254564	Calgary	Alberta
Canada	Dermatology Research Institute - Blackfoot Trail /ID# 261413	Calgary	Alberta
Canada	Rejuvenation Dermatology - Edmonton Downtown /ID# 254715	Edmonton	Alberta
Canada	LEADER Research /ID# 254379	Hamilton	Ontario
Canada	DermEffects /ID# 254116	London	Ontario
Canada	Lynde Institute for Dermatology /ID# 254713	Markham	Ontario
Canada	SKDS Research /ID# 254714	Newmarket	Ontario
Canada	Diex Recherche Québec Inc. /ID# 254381	Québec	Quebec
Canada	York Dermatology Clinic and Research Centre /ID# 254115	Richmond Hill	Ontario
Canada	Dre Angelique Gagne-Henley M.D. inc. /ID# 255632	Saint-Jerome	Quebec
Canada	SkinSense Dermatology /ID# 254119	Saskatoon	Saskatchewan
Canada	Karma Clinical Trials /ID# 254120	St. John's	Newfoundland and Labrador
Canada	Dr. Chih-ho Hong Medical Inc. /ID# 254378	Surrey	British Columbia
Canada	Enverus Medical Research /ID# 254380	Surrey	British Columbia
Canada	Research Toronto /ID# 255273	Toronto	Ontario
Canada	Wiseman Dermatology Research /ID# 254117	Winnipeg	Manitoba
Chile	Fundacion Innovacion Cardiovascular /ID# 254561	Independencia	Region Metropolitana De Santiago
Chile	Sociedad Icalma Spa /Id# 254560	Las Condes
Chile	Centro Internacional de Estudios Clinicos - CIEC /ID# 254559	Santiago
Chile	Clinica Dermacross /ID# 254558	Santiago
Croatia	Poliklinika Solmed /ID# 254732	Grad Zagreb
Croatia	Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 253586	Ivanic-Grad	Zagrebacka Zupanija
Croatia	Specialty hospital Medico /ID# 254731	Rijeka
Croatia	Klinicki Bolnicki Centar (KBC) Split /ID# 253789	Split	Splitsko-dalmatinska Zupanija
Croatia	DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 253587	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 253786	Zagreb	Grad Zagreb
Croatia	Klinika za djecje bolesti Zagreb /ID# 253588	Zagreb	Grad Zagreb
Czechia	Karlovarska Krajska Nemocnice - Karlovy Vary /ID# 253456	Karlovy Vary
Czechia	Duplicate_Fakultni Nemocnice v Motole /ID# 253455	Prague
Czechia	Fakultni nemocnice Kralovske Vinohrady /ID# 253454	Praha
Finland	Oulun yliopistollinen sairaala /ID# 253969	Oulu
Finland	Terveystalo Tampere /ID# 253968	Tampere
France	Hopital Prive d'Antony /ID# 253501	Antony	Ile-de-France
France	Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 254139	Bordeaux	Gironde
France	HCL - Hopital Edouard Herriot /ID# 253500	Lyon	Rhone
France	CHU de Nantes, Hotel Dieu -HME /ID# 254114	Nantes	Pays-de-la-Loire
France	Chu de Nice-Hopital Larchet Ii /Id# 253504	Nice	Alpes-Maritimes
France	Polyclinique Courlancy /ID# 254680	Reims	Marne
Germany	Havelklinik /ID# 254194	Berlin
Germany	Klinikum Ruhr Univ Bochum /ID# 253690	Bochum
Germany	Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 254510	Bramsche
Germany	Magdeburger Company for Medical Studies & Services GmbH /ID# 255151	Magdeburg
Germany	Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 253691	Mainz
Germany	Klinik am Biederstein /ID# 254195	Munich
Germany	Universitaetsklinikum Regensburg /ID# 253692	Regensburg
Greece	401 GSNA - 401 Army General Hospital /ID# 253499	Athens	Attiki
Greece	General Hospital Andreas Syggros /ID# 253498	Athens	Attiki
Greece	University General Hospital Attikon /ID# 253495	Athens	Attiki
Greece	Papageorgiou General Hospital /ID# 253496	Thessaloniki
Hungary	Csalogany Orvosi Kozpont /ID# 255063	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft. /ID# 256366	Budapest
Hungary	Debreceni Egyetem-Klinikai Kozpont /ID# 253637	Debrecen	Hajdu-Bihar
Hungary	DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 253638	Debrecen
Hungary	Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 253913	Kaposvár	Somogy
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 253753	Pecs
Hungary	Szegedi Tudományegyetem /ID# 255142	Szeged
Ireland	South Infirmary Victoria University Hospital /ID# 253975	Cork
Ireland	University College Dublin /ID# 253971	Dublin
Ireland	St James Hospital /ID# 253973	Dublin 8	Dublin
Ireland	University Hospital Galway /ID# 253976	Galway
Ireland	Waterford Regional Hospital /ID# 254038	Waterford
Israel	Rabin Medical Center /ID# 254405	Haifa
Israel	Rambam Health Care Campus /ID# 254406	Haifa	H_efa
Israel	Sheba Medical Center /ID# 254545	Ramat Gan	Tel-Aviv
Israel	ZIV Medical Center /ID# 254403	Safed	HaTsafon
Israel	Tel Aviv Sourasky Medical Center /ID# 254404	Tel Aviv	Tel-Aviv
Italy	ASST Spedali civili di Brescia /ID# 254875	Brescia
Italy	Azienda Ospedaliero Universitaria di Ferrara - Ospedale Sant'Anna /ID# 254496	Cona	Ferrara
Italy	Ospedale Piero Palagi /ID# 254495	Florence
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 254502	Milan
Italy	Azienda Ospedaliero Universitaria Pisana /ID# 254501	Pisa
Italy	Fondazione Policlinico Universitario Agostino Gemelli /ID# 254500	Roma
Italy	Fondazione PTV Policlinico Tor Vergata /ID# 254498	Rome	Roma
Japan	Fukuoka University Hospital /ID# 254729	Fukuoka-shi	Fukuoka
Japan	Nihon University Itabashi Hospital /ID# 254637	Itabashi-ku	Tokyo
Japan	University Hospital Kyoto Prefectural University of Medicine /ID# 254481	Kyoto-shi	Kyoto
Japan	Toranomon Hospital /ID# 253819	Minato-ku	Tokyo
Japan	University of the Ryukyus Hospital /ID# 254517	Nakagami-gun	Okinawa
Japan	Meiwa Hospital /ID# 254728	Nishinomiya-shi	Hyogo
Japan	Kindai University Hospital /ID# 254574	Osakasayama-shi	Osaka
Japan	Shiga University of Medical Science Hospital /ID# 254215	Otsu-shi	Shiga
Japan	Tohoku University Hospital /ID# 254598	Sendai-shi	Miyagi
Japan	University of Tsukuba Hospital /ID# 254638	Tsukuba-shi	Ibaraki
Korea, Republic of	Korea University Ansan Hospital /ID# 254128	Ansan	Gyeonggido
Korea, Republic of	CHA Bundang Medical Center /ID# 254026	Seongnam	Gyeonggido
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital /ID# 254127	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 254027	Seoul
Korea, Republic of	SoonChunHyang University Seoul Hospital /ID# 254025	Seoul
Lithuania	Inlita Santara CTC /ID# 253917	Vilnius
Lithuania	Vilnius University Hospital Santaros Klinikos /ID# 253916	Vilnius
Netherlands	Amphia Ziekenhuis /ID# 253567	Breda	Noord-Brabant
Netherlands	Universitair Medisch Centrum Groningen /ID# 253571	Groningen
New Zealand	Greenlane Clinical Centre /ID# 254351	Epsom	Auckland
New Zealand	Clinical Trials New Zealand /ID# 254352	Hamilton
Portugal	Hospital CUF Descobertas /ID# 254323	Lisboa
Portugal	Centro Hospitalar de Lisboa Central /ID# 254325	Lisbon
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 254324	Porto
Portugal	Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 254322	Porto
Puerto Rico	Dr. Samuel Sanchez PSC /ID# 253948	Caguas
Puerto Rico	Alma M. Cruz Santana, MD-Private practice /ID# 253951	Carolina
Saudi Arabia	King Faisal Specialist Hospital /ID# 255539	Jeddah	Makkah
Saudi Arabia	King Abdulaziz Medical City- National Guard Hospital /ID# 255280	Riyadh	Ar Riyad
Saudi Arabia	King Faisal Specialist Hospital and Research Centre /ID# 255279	Riyadh	Ar Riyad
Saudi Arabia	King Saud University Med City /ID# 255282	Riyadh
Singapore	National Skin Centre /ID# 255242	Singapore	Central Singapore
Singapore	National University Hospital /ID# 254943	Singapore
Slovakia	Univerzitna nemocnica Bratislava /ID# 254157	Bratislava
Slovakia	Univerzitna nemocnica Martin /ID# 254153	Martin	Zilinsky Kraj
Slovakia	Fakultna nemocnica Trnava /ID# 254137	Trnava
Spain	Hospital General de Granollers /ID# 253873	Barcelona
Spain	Hospital Santa Creu i Sant Pau /ID# 253869	Barcelona
Spain	Hospital Universitario Virgen de las Nieves /ID# 253870	Granada
Spain	Hospital Universitari de Bellvitge /ID# 254982	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario Ramon y Cajal /ID# 253871	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253924	Majadahonda	Madrid
Spain	Hospital de Manises /ID# 253867	Manises	Valencia
Spain	Hospital Universitario y Politecnico La Fe /ID# 253868	Valencia
Sweden	Karolinska Universitetssjukhuset Solna /ID# 254808	Solna
Switzerland	Inselspital, Universitaetsspital Bern /ID# 254736	Bern
Switzerland	Kantonsspital St. Gallen /ID# 255243	St. Gallen	Sankt Gallen
Switzerland	University Hospital Zurich /ID# 254642	Zürich
Taiwan	Changhua Christian Hospital /ID# 254032	Changhua City, Changhua County
Taiwan	Kaohsiung Chang Gung Memorial Hospital /ID# 254031	Kaohsiung City	Kaohsiung
Taiwan	National Taiwan University Hospital /ID# 254030	Taipei City
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 254033	Taoyuan City
Turkey	Uludag University Medical Faculty /ID# 253806	Bursa
Turkey	Ondokuz Mayis Universitesi Tip /ID# 254034	Samsun
United Kingdom	Leeds Teaching Hospitals NHS Trust /ID# 254616	Leeds
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust /ID# 254190	London
United Kingdom	Northern Care Alliance NHS Group /ID# 256910	Salford
United Kingdom	University Hospital Southampton NHS Foundation Trust /ID# 254531	Southampton	Hampshire
United Kingdom	St George's University Hospitals NHS Foundation Trust /ID# 256803	Tooting
United States	Arlington Research Center, Inc /ID# 253805	Arlington	Texas
United States	Bellaire Dermatology Associates /ID# 253797	Bellaire	Texas
United States	Cahaba Dermatology & Skin Health Center /ID# 254876	Birmingham	Alabama
United States	Skin Care Research Boca Raton /ID# 253814	Boca Raton	Florida
United States	Treasure Valley Medical Research /ID# 255208	Boise	Idaho
United States	Beth Israel Deaconess Medical Center /ID# 253811	Boston	Massachusetts
United States	Apex Clinical Trials /ID# 255756	Brandon	Florida
United States	Onsite Clinical Solutions /ID# 254854	Charlotte	North Carolina
United States	University of Virginia - Dermatology /ID# 254535	Charlottesville	Virginia
United States	DeNova Research /ID# 254372	Chicago	Illinois
United States	Northwestern University Feinberg School of Medicine /ID# 254503	Chicago	Illinois
United States	Centricity Research /ID# 255470	Columbus	Georgia
United States	ClinOhio Research Services /ID# 254851	Columbus	Ohio
United States	Florida Academic Dermatology Center /ID# 254011	Coral Gables	Florida
United States	Dermatology Treatment and Research Center /ID# 253795	Dallas	Texas
United States	HRMD Research Dallas /ID# 255256	Dallas	Texas
United States	Modern Research Associates, PLLC /ID# 253810	Dallas	Texas
United States	Private Practice - Dr. Joseph Raoof /ID# 254374	Encino	California
United States	UConn Health Main /ID# 254507	Farmington	Connecticut
United States	Clinical Trials Institute - Northwest Arkansas /ID# 254924	Fayetteville	Arkansas
United States	Dallas Fort Worth Clinical Research Associates (DFWCRA) /ID# 256438	Grapevine	Texas
United States	Skin Care Research - Hollywood /ID# 254508	Hollywood	Florida
United States	Burke Pharmaceutical Research /ID# 254238	Hot Springs	Arkansas
United States	Suzanne Bruce and Associates-Houston /ID# 254228	Houston	Texas
United States	Dawes Fretzin, LLC /ID# 254390	Indianapolis	Indiana
United States	Dermatology Associates of Knoxville /ID# 261082	Knoxville	Tennessee
United States	Vivida Dermatology- Flamingo /ID# 254227	Las Vegas	Nevada
United States	U.S. Dermatology Partners Leawood /ID# 255838	Leawood	Kansas
United States	Dermatology and Skin Center of Lees Summit /ID# 257546	Lee's Summit	Missouri
United States	Dermatology Research Associates /ID# 254846	Los Angeles	California
United States	The Education & Research Foundation, Inc. /ID# 254852	Lynchburg	Virginia
United States	Life Clinical Trials - Margate - FL-7 /ID# 258613	Margate	Florida
United States	Dermatologists of Southwest Ohio, Inc /ID# 254297	Mason	Ohio
United States	North Sound Dermatology /ID# 254554	Mill Creek	Washington
United States	University of Utah /ID# 254452	Murray	Utah
United States	Yale University School of Medicine /ID# 254586	New Haven	Connecticut
United States	NorthWell Health - Dermatology /ID# 254704	New Hyde Park	New York
United States	Virginia Clinical Research, Inc. /ID# 254538	Norfolk	Virginia
United States	Arkansas Research Trials /ID# 254233	North Little Rock	Arkansas
United States	Lynn Institute of Oklahoma City /ID# 253791	Oklahoma City	Oklahoma
United States	Clinical Research of Philadelphia, LLC /ID# 255308	Philadelphia	Pennsylvania
United States	Paddington Testing Co., Inc. /ID# 254394	Philadelphia	Pennsylvania
United States	Medical Dermatology Specialists /ID# 254226	Phoenix	Arizona
United States	Texas Dermatology Research Center, LLC /ID# 254928	Plano	Texas
United States	Beacon Clinical Research, LLC /ID# 254419	Quincy	Massachusetts
United States	Skin Cancer and Dermatology Institute - Reno /ID# 254410	Reno	Nevada
United States	NW Arkansas Clinical Trials Center /ID# 254311	Rogers	Arkansas
United States	Integrative Skin Science and Research /ID# 254930	Sacramento	California
United States	UC Davis Health /ID# 254229	Sacramento	California
United States	MediSearch Clinical Trials /ID# 254392	Saint Joseph	Missouri
United States	Washington University School of Medicine - St. Louis /ID# 254506	Saint Louis	Missouri
United States	Medderm Associates /ID# 253800	San Diego	California
United States	Northshore University Health System Dermatology Clinical Trials Unit /ID# 254389	Skokie	Illinois
United States	Premier Clinical Research /ID# 254847	Spokane	Washington
United States	Advanced Clinical Research Institute /ID# 253746	Tampa	Florida
United States	Avita Clinical Research /ID# 254471	Tampa	Florida
United States	Skin Care Research - Tampa /ID# 256440	Tampa	Florida
United States	Clinical Trials Research Institute /ID# 254466	Thousand Oaks	California
United States	Banner University Medicine Dermatology /ID# 255853	Tucson	Arizona
United States	Schweiger Dermatology, P.C. /ID# 254232	Verona	New Jersey
United States	Michigan Dermatology Institute /ID# 254468	Waterford	Michigan
United States	Center for Clinical Studies Webster TX /ID# 254242	Webster	Texas
United States	Options Research Group /ID# 254537	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Croatia,  Czechia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Netherlands,  New Zealand,  Portugal,  Puerto Rico,  Saudi Arabia,  Singapore,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50	HiSCR 50 is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.	Baseline to Week 16
Secondary	Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75	HiSCR 75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.	Baseline to Week 16
Secondary	Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 4 Among Participants with NRS = 3 at Baseline	Achievement will be considered at least a 30% reduction and at least 2 units reduction from Baseline in the Participant's Global Assessment (PGA) of HS-related skin pain NRS based on worst skin pain in a 24-hour recall period (maximal daily pain). The PGA Skin Pain is an 11-point numerical rating scale with ratings for the item ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).	Baseline to Week 4
Secondary	Occurrence of Hidradenitis Suppurativa (HS) Flare During Period 1	Defined as at least one occurrence of a = 25% increase in AN count, with a minimum absolute increase of 2 relative to Baseline.	Week 16
Secondary	Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)	The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.	Baseline to Week 16
Secondary	Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)	The HSIA is an 18-item PRO questionnaire developed to assess the impact of HS on the daily lives of subjects in the 7 days prior to the assessment. Items 1 - 16 of the HSIA are scored on a 0 to 10 NRS, where 0 represents no impact and 10 represents extreme impact.	Baseline to Week 16
Secondary	Change from Baseline in Dermatology Life Quality Index (DLQI) for Adult Participants and Adolescent Participants Age =16 Years Old	The DLQI and the CDLQI are both 10-item questionnaires used to assess the impact of hidradenitis suppurativa (HS) disease symptoms and treatment on quality of life that consists of 10 questions scored on a 4-point scale where 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much.	Baseline to Week 16
Secondary	Change from Baseline in Hidradenitis Suppurativa (HS)-Related Odor, Based on Hidradenitis Suppurativa Symptom Assessment (HSSA) Question 8	The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.	Baseline to Week 16
Secondary	Change from Baseline in the Patient's Global Assessment of Hidradenitis Suppurativa (HS)-Related Skin Pain NRS	The PGA Skin Pain is an 11-point numerical rating scale with ratings for the item ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) that is used to assess the worst pain due to HS. Patients are asked to respond to the item based on a recall period of "the last 24 hours".	At Week 8

External Links

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