Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

Sponsor

AbbVie (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04195698

Collaborator

(none)

485

Enrollment

116

Locations

Arm

43.9

Anticipated Duration (Months)

4.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.

Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Upadacitinib	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

485 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 3b, Open-Label Treatment Extension Study of Upadacitinib For the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis Who Completed Treatment in Study M16-046

Actual Study Start Date :

Jan 15, 2020

Anticipated Primary Completion Date :

Sep 12, 2023

Anticipated Study Completion Date :

Sep 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Upadacitinib Participants will be administered with upadacitinib once daily (QD)	Drug: Upadacitinib Upadacitinib will be administered oral as tablet Other Names: ABT-494 RINVOQ

Arm

Intervention/Treatment

Experimental: Upadacitinib

Participants will be administered with upadacitinib once daily (QD)

Drug: Upadacitinib

Upadacitinib will be administered oral as tablet

Other Names:

ABT-494

RINVOQ

Outcome Measures

Primary Outcome Measures

Number of Participants With Adverse Events [From Baseline to 30 days following last dose of study drug (Week 52)]
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation criteria.
Participant is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the study M16-046 to continue treatment in the long term extension study.

Exclusion Criteria:

Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences /ID# 221021	Little Rock	Arkansas	United States	72205
2	First OC Dermatology /ID# 218619	Fountain Valley	California	United States	92708-3701
3	UCSF Fresno /ID# 218453	Fresno	California	United States	93701-2302
4	California Allergy and Asthma Medical Group /ID# 218635	Los Angeles	California	United States	90025-7014
5	Dermatology Research Associates /ID# 218637	Los Angeles	California	United States	90045
6	Dermatology Clinical Trials /ID# 218627	Newport Beach	California	United States	92660-7853
7	UC Davis Health /ID# 218582	Sacramento	California	United States	95816-3300
8	Ucsd /Id# 218629	San Diego	California	United States	92103
9	Clinical Science Institute /ID# 218632	Santa Monica	California	United States	90404-2102
10	Miami Dermatology and Laser Institute /ID# 218664	Miami	Florida	United States	33173-3570
11	Florida International Rsrch cr /ID# 218663	Miami	Florida	United States	33173
12	GCP Research /ID# 218665	Saint Petersburg	Florida	United States	33705
13	Clinical Research Trials of Florida, Inc. /ID# 218438	Tampa	Florida	United States	33607
14	Georgia Pollens Clinical Research Centers, Inc /ID# 218441	Albany	Georgia	United States	31707-1282
15	Medical Dermatology Associates of Chicago /ID# 218551	Chicago	Illinois	United States	60654-6903
16	Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552	Normal	Illinois	United States	61761
17	Dawes Fretzin, LLC /ID# 218478	Indianapolis	Indiana	United States	46256
18	Beacon Clinical Research, LLC /ID# 218636	Quincy	Massachusetts	United States	02169
19	Michigan Center for Research Company /ID# 218577	Clarkston	Michigan	United States	48346
20	Henry Ford Medical Center /ID# 218575	Detroit	Michigan	United States	48202-3046
21	Allergy, Asthma & Immunology Associates, PC /ID# 218548	Lincoln	Nebraska	United States	68505-2343
22	Skin Specialists, PC /ID# 218549	Omaha	Nebraska	United States	68144
23	University Hospitals Case Medical Center /ID# 218574	Cleveland	Ohio	United States	44106
24	Southside Dermatology /ID# 218477	Tulsa	Oklahoma	United States	74132
25	Oregon Medical Res Center PC /ID# 218440	Portland	Oregon	United States	97223
26	Oregon Health and Science University /ID# 218578	Portland	Oregon	United States	97239
27	Medical University of South Carolina /ID# 221072	Charleston	South Carolina	United States	29425
28	Clinical Research Solutions, LLC /ID# 218447	Jackson	Tennessee	United States	38305-2163
29	Orion Clinical Research /ID# 218565	Austin	Texas	United States	78759-4100
30	Sante Clinical Research /ID# 218911	Kerrville	Texas	United States	78028-9640
31	Clinical Research Partners, LLC /ID# 218480	Richmond	Virginia	United States	23220-4459
32	Premier Clinical Research /ID# 218583	Spokane	Washington	United States	99202
33	West Virginia Research Inst /ID# 218479	South Charleston	West Virginia	United States	25309
34	Holdsworth House Medical Practice /ID# 218755	Darlinghurst	New South Wales	Australia	2010
35	The Skin Hospital /ID# 218753	Darlinghurst	New South Wales	Australia	2010
36	Veracity Clinical Research /ID# 218754	Woolloongabba	Queensland	Australia	4102
37	Sinclair Dermatology /ID# 218751	East Melbourne	Victoria	Australia	3002
38	Burswood Dermatology /ID# 218752	Victoria Park	Western Australia	Australia	6100
39	Kirk Barber Research, CA /ID# 218727	Calgary	Alberta	Canada	T2G 1B1
40	Dermatology Research Institute Inc. /ID# 218728	Calgary	Alberta	Canada	T2J 7E1
41	Dr. Chih-ho Hong Medical Inc. /ID# 218725	Surrey	British Columbia	Canada	V3R 6A7
42	Enverus Medical Research /ID# 218726	Surrey	British Columbia	Canada	V3V 0C6
43	Dr. Wei Jing Loo Medicine Prof /ID# 218722	London	Ontario	Canada	N6H 5L5
44	Lynderm Research Inc. /ID# 218723	Markham	Ontario	Canada	L3P 1X2
45	DermEdge Research Inc. /ID# 218721	Mississauga	Ontario	Canada	L5H 1G9
46	Niakosari Medicine Professional Corporation /ID# 218729	Toronto	Ontario	Canada	M2M 4J5
47	K. Papp Clinical Research /ID# 218730	Waterloo	Ontario	Canada	N2J 1C4
48	Dre Angelique Gagne-Henley M.D. inc. /ID# 218724	Saint-Jerome	Quebec	Canada	J7Z 7E2
49	DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 218377	Zagreb	Grad Zagreb	Croatia	10000
50	Klinicki bolnicki centar Zagreb /ID# 218375	Zagreb	Grad Zagreb	Croatia	10000
51	Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 218376	Ivanic-Grad	Zagrebacka Zupanija	Croatia	10310
52	Fakultni nemocnice Hradec Kralove /ID# 214176	Hradec Kralove		Czechia	500 05
53	Nemocnice Jihlava, prispevkova organizace /ID# 214178	Jihlava		Czechia	586 01
54	Fakultni nemocnice Ostrava /ID# 214177	Ostrava		Czechia	708 52
55	Fakultni Nemocnice v Motole /ID# 214179	Praha		Czechia	150 06
56	Keski-pohjanmaa Central Hospital /ID# 214630	Kokkola	Keski-Pohjanmaa	Finland	67200
57	Oulun yliopistollinen sairaala /ID# 214628	Oulu	Pohjois-Pohjanmaa	Finland	90220
58	Mikkeli Central Hospital /ID# 214629	Mikkeli		Finland	50100
59	AP-HM - Hopital de la Timone /ID# 218957	Marseille CEDEX 05	Bouches-du-Rhone	France	13385
60	CHU de Nantes, Hotel Dieu -HME /ID# 218959	Nantes	Pays-de-la-Loire	France	44000
61	Polyclinique Courlancy /ID# 218955	Reims		France	51100
62	Hôpital Charles-Nicolle /ID# 218960	Rouen		France	76000
63	CHU Toulouse - Hopital Larrey /ID# 218958	Toulouse		France	31400
64	Universitaetsklinikum Frankfurt /ID# 214223	Frankfurt am Main	Hessen	Germany	60590
65	Universitatsklinikum Munster /ID# 214222	Munster	Niedersachsen	Germany	48149
66	Klinikum Darmstadt /ID# 214224	Darmstadt		Germany	64283
67	Medizinische Hochschule Hannover /ID# 214226	Hannover		Germany	30625
68	Dermatologische Gemeinschaftspraxis Mahlow /ID# 214225	Mahlow		Germany	15831
69	Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214221	Munich		Germany	81675
70	Oroshazi Korhaz /ID# 214986	Oroshaza	Bekes	Hungary	5900
71	Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 214984	Kaposvár	Somogy	Hungary	7400
72	Uno Medical Trials Kft /ID# 214987	Budapest		Hungary	1135
73	St Vincent's University Hospital /ID# 213558	Elm Park	Dublin	Ireland	D04 T6F4
74	The Chaim Sheba Medical Center /ID# 218522	Ramat Gan	Tel-Aviv	Israel	5265601
75	HaEmek Medical Center /ID# 218520	Afula		Israel	1834111
76	Rabin Medical Center /ID# 218521	Petakh Tikva		Israel	4941492
77	Istituto Clinico Humanitas /ID# 215727	Rozzano	Milano	Italy	20089
78	Fondazione PTV Policlinico Tor Vergata /ID# 214093	Rome	Roma	Italy	00133
79	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214095	Milan		Italy	20122
80	Azienda Ospedaliero-Universitaria di Modena /ID# 214096	Modena		Italy	41124
81	Hospital Sultan Ismail /ID# 218881	Johor Bahru	Johor	Malaysia	81100
82	Hospital Pakar Sultanah Fatimah /ID# 218877	Muar	Johor	Malaysia	84000
83	Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 218879	Kuala Lumpur	Selangor	Malaysia	56000
84	Hospital Putrajaya /ID# 218880	Putrajaya	Wilayah Persekutuan Putrajaya	Malaysia	62250
85	University Malaya Med Ctr /ID# 218882	Kuala Lumpur		Malaysia	59100
86	Hospital Pulau Pinang /ID# 218878	Penang		Malaysia	10450
87	Bravis Ziekenhuis /ID# 218772	Bergen op Zoom	Noord-Brabant	Netherlands	4624 VT
88	Erasmus Medisch Centrum /ID# 218770	Rotterdam	Zuid-Holland	Netherlands	3015 GD
89	Universitair Medisch Centrum Groningen /ID# 218775	Groningen		Netherlands	9713 GZ
90	Universitair Medisch Centrum Utrecht /ID# 218771	Utrecht		Netherlands	3584 CX
91	Optimal Clinical Trials Ltd /ID# 218688	Grafotn	Auckland	New Zealand	1010
92	Wellington Regional Hospital /ID# 218689	Newtown	Wellington	New Zealand	6021
93	Clinical Trials NZ /ID# 218690	Hamilton		New Zealand	3204
94	Universitetssykehuset N-Norge, Tromso /ID# 214634	Tromso	Troms	Norway	9019
95	Dermoklinika Centrum Medyczne s.c. /ID# 214300	Lodz	Lodzkie	Poland	90-436
96	Pratia MCM Krakow /ID# 214303	Krakow	Malopolskie	Poland	30-510
97	Klinika Ambroziak Sp. z o.o. /ID# 214301	Warsaw	Mazowieckie	Poland	02-758
98	Royalderm Agnieszka Nawrocka /ID# 214302	Warszawa	Mazowieckie	Poland	02-962
99	ClinicMed Daniluk, Nowak Sp.j. /ID# 214299	Bialystok	Podlaskie	Poland	15-879
100	National University Hospital /ID# 219093	Singapore		Singapore	119074
101	Hospital Universitario de Bellvitge /ID# 214257	L'Hospitalet de Llobregat	Barcelona	Spain	08907
102	Hospital Universitario Dr. Negrin /ID# 214256	Las Palmas de Gran Canaria	Las Palmas	Spain	35019
103	Hospital de Manises /ID# 214258	Manises	Valencia	Spain	46940
104	Complejo Hospitalario Universitario de Pontevedra /ID# 214255	Pontevedra		Spain	36071
105	Hospital Universitario Arnau Vilanova /ID# 214254	Valencia		Spain	46015
106	Hospital Universitario y Politecnico La Fe /ID# 214252	Valencia		Spain	46026
107	China Medical University Hospital /ID# 218409	Taichung City		Taiwan	40447
108	Chung Shan Medical University Hospital /ID# 218919	Taichung		Taiwan	40201
109	National Taiwan University Hospital /ID# 218917	Taipei City		Taiwan	100
110	Taipei Municipal Wan Fang Hospital /ID# 218918	Taipei		Taiwan	116
111	Kyiv City Clinical Skin and Venereal Hospital /ID# 218382	Kyiv	Kyivska Oblast	Ukraine	04209
112	ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 218385	Rivne		Ukraine	33028
113	Victoria Hospital /ID# 213564	Kirkcaldy	Fife	United Kingdom	KY2 5AH
114	The Royal Free London NHS Foundation Trust /ID# 213560	London	London, City Of	United Kingdom	NW3 2QG
115	NHS Greater Glasgow and Clyde /ID# 213561	Glasgow	Scotland	United Kingdom	G12 0XH
116	University Hospitals Sussex NHS Foundation Trust /ID# 213562	Worthing		United Kingdom	BN11 2DH