Phase
Condition
Allergy
Dermatitis, Atopic
Scalp Disorders
Treatment
GSK1070806
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must sign and date the consent document.
Participants diagnosed with moderate to severe Atopic dermatitis (AtD) who havecompleted the qualifying Phase 2 parent study (NCT05999799) of GlaxoSmithKline (GSK's) AtD and, in their opinion, may benefit from GSK1070806.
Be intentional and able to visit the doctor at the clinic by appointment and followall procedures related to research studies and questionnaires (able to read andunderstand Patient-reported outcomes (PRO) questionnaires and be able to useelectronic devices).
The use of contraceptive methods for females should be consistent with localregulations on contraceptive methods of participants participating in clinicalresearch programs.
Female participants are eligible to participate in the research program if they arenot pregnant or breastfeeding and meet one of the following conditions:
It is Woman of nonchildbearing potential (WONCBP).
It is Woman of childbearing potential (WOCBP) and uses a highly effectivecontraceptive method that has a failure rate less than (<) 1 percent (%) during thetrial dose period and for at least 16 weeks after the last dose of the researchdrug. We should assess the likelihood of contraceptive failure (e.g.,non-cooperation, early contraception) associated with the first dose of the drug.
WOCBP must obtain a negative result in a highly sensitive pregnancy test (by urineor serum test, as prescribed by local regulations) before receiving the first doseof the research drug.
If the urine test is positive, or the negative result cannot be confirmed (i.e., theresult is unclear), a pregnancy test by serum test is required. In such cases, Ifthe serum is tested, the test result is positive. Participants must be excluded fromthe research project.
Additional requirements for testing pregnancy during and after exposure to the drug.
The researcher is responsible for examining medical history, menstrual cyclehistory, and sexual activity in the near term. To reduce the risk of screeningpregnant women who may not be detected at the beginning of pregnancy.
Exclusion
Exclusion Criteria:
Permanent discontinuation of the study drug at any time during GSK's qualifyingPhase 2 AtD (NCT05999799) or a medical condition that would hinder GSK'sparticipation in the Phase 2 219538 (NCT05999799) AtD research project.
Participants who, during GSK's qualifying Phase 2 (NCT05999799) AtD researchproject, developed adverse event (AE) or Serious adverse event (SAE) based onlaboratory parameters, physical examination, vital signs, Electrocardiogram (ECG),medical history, etc. Medical history, in the opinion of the researchers, suggeststhat if Investigational medicinal product (IMP) is continued, it may causeunnecessary risk to the participants.
Topical medications for AtD within 1 week prior to your appointment at Day 1, suchas: Topical calcineurin inhibitors (TCI)/ Topical corticosteroids (TCS),Phosphodiesterase-4 (PDE-4) and Janus activation kinase inhibitors (JAKi) forexternal use.
Topical corticosteroids (TCS) (such as hydrocortisone, betamethasone)
Topical calcineurin inhibitors (TCI) (such as tacrolimus, pimecrolimus)
Phosphodiesterase-4 (PDE4) inhibitor for external use (e.g., crisaborole)
JAKi for external use (e.g. ruxolitinib)
Medications for topical use, or other herbal/traditional medicines that may affectthe AtD that the participants are in.
Participant who received systemic therapy, which is considered contraindicated,including systemic therapy used as a rescue medication for AtD, from the screeningfor GSK's Phase 2 AtD 219538 research project until the LTE protocol began, wereunable to participate in the research project.
Chronic uncontrolled diseases that may require immediate oral corticosteroids, suchas severe uncontrolled asthma (defined as having an Asthma control questionnaire (ACQ)-5 score greater than or equal to (>=) of 1.5 or a history of asthmaexacerbations. >= 2 times within the last 12 months, requiring systemiccorticosteroid [oral and/or intravenous medication] or requiring a >-24-hourhospital stay)
Experience participating in previous/current clinical research projects.
The participants have participated in any other clinical research studies. This isin addition to GSK's Phase 2 219538 (NCT05999799) research project.
Study Design
Connect with a study center
GSK Investigational Site
Caba, Buenos Aires C1055AAO
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires C1207AAP
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, C1181ACH
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autonoma De Bueno, C1056ABI
ArgentinaSite Not Available
GSK Investigational Site
Cordoba, X5000AAW
ArgentinaSite Not Available
GSK Investigational Site
Mendoza, 5500
ArgentinaSite Not Available
GSK Investigational Site
Rosario, S2002
ArgentinaSite Not Available
GSK Investigational Site
Pleven, 5800
BulgariaSite Not Available
GSK Investigational Site
Sofia, 1510
BulgariaSite Not Available
GSK Investigational Site
London, Ontario N6H 5L5
CanadaSite Not Available
GSK Investigational Site
Markham, Ontario L3P1X2
CanadaSite Not Available
GSK Investigational Site
Barrie,
CanadaSite Not Available
GSK Investigational Site
Quebec, G1W 4R4
CanadaSite Not Available
GSK Investigational Site
Beijing, 100044
ChinaSite Not Available
GSK Investigational Site
Chongqing, 400016
ChinaSite Not Available
GSK Investigational Site
Fu Zhou, 350014
ChinaSite Not Available
GSK Investigational Site
Fuzhou, 350014
ChinaSite Not Available
GSK Investigational Site
Guangzhou,
ChinaSite Not Available
GSK Investigational Site
Hangzhou, 310000
ChinaSite Not Available
GSK Investigational Site
Shanghai,
ChinaSite Not Available
GSK Investigational Site
Yinchuan,
ChinaSite Not Available
GSK Investigational Site
Yiwu City, 322000
ChinaSite Not Available
GSK Investigational Site
Pardubice,
CzechiaSite Not Available
GSK Investigational Site
Prague, 10034
CzechiaSite Not Available
GSK Investigational Site
Praha,
CzechiaSite Not Available
GSK Investigational Site
Praha 2, 128 08
CzechiaSite Not Available
GSK Investigational Site
La Rochelle Cedex 1, 17019
FranceSite Not Available
GSK Investigational Site
Nice, 06200
FranceSite Not Available
GSK Investigational Site
Paris cedex 10, 75475
FranceSite Not Available
GSK Investigational Site
Berlin, 10789
GermanySite Not Available
GSK Investigational Site
Essen, 45122
GermanySite Not Available
GSK Investigational Site
Hamburg, 22391
GermanySite Not Available
GSK Investigational Site
Kiel, 24105
GermanySite Not Available
GSK Investigational Site
Muenster, 48149
GermanySite Not Available
GSK Investigational Site
Athens,
GreeceSite Not Available
GSK Investigational Site
Thessaloniki, 546 43
GreeceSite Not Available
GSK Investigational Site
Bari, 70124
ItalySite Not Available
GSK Investigational Site
Bologna, 40138
ItalySite Not Available
GSK Investigational Site
Firenze,
ItalySite Not Available
GSK Investigational Site
Modena, 41124
ItalySite Not Available
GSK Investigational Site
Roma, 00128
ItalySite Not Available
GSK Investigational Site
Chiba, 272-0033
JapanSite Not Available
GSK Investigational Site
Fukuoka, 812-8582
JapanSite Not Available
GSK Investigational Site
Gunma, 370-0829
JapanSite Not Available
GSK Investigational Site
Hokkaido, 080-0013
JapanSite Not Available
GSK Investigational Site
Kanagawa, 211-0063
JapanSite Not Available
GSK Investigational Site
Osaka, 593-8324
JapanSite Not Available
GSK Investigational Site
Saitama, 343-8555
JapanSite Not Available
GSK Investigational Site
Ansan, 15355
Korea, Republic ofSite Not Available
GSK Investigational Site
Gyeonggi-do, 15355
Korea, Republic ofSite Not Available
GSK Investigational Site
Seoul, 04763
Korea, Republic ofSite Not Available
GSK Investigational Site
Durango., Durango 34000
MexicoSite Not Available
GSK Investigational Site
Chihuahua, 31000
MexicoSite Not Available
GSK Investigational Site
Durango, 34000
MexicoSite Not Available
GSK Investigational Site
Guadalajara, 44628
MexicoSite Not Available
GSK Investigational Site
Monterrey, 64718
MexicoSite Not Available
GSK Investigational Site
Ciudad de Panama, 7099
PanamaSite Not Available
GSK Investigational Site
Chojnice, 89-600
PolandSite Not Available
GSK Investigational Site
Elblag, 82-300
PolandSite Not Available
GSK Investigational Site
Katowice, 40-600
PolandSite Not Available
GSK Investigational Site
Poznan, 60-569
PolandSite Not Available
GSK Investigational Site
Szczecin, 70-332
PolandSite Not Available
GSK Investigational Site
Warsaw, 03-291
PolandSite Not Available
GSK Investigational Site
Majadahonda, Madrid 28222
SpainSite Not Available
GSK Investigational Site
Alicante, 03010
SpainSite Not Available
GSK Investigational Site
COrdoba, 14004
SpainSite Not Available
GSK Investigational Site
Córdoba, 14004
SpainSite Not Available
GSK Investigational Site
Granada, 18016
SpainSite Not Available
GSK Investigational Site
Madrid, 28222
SpainSite Not Available
GSK Investigational Site
Valencia, 46026
SpainSite Not Available
GSK Investigational Site
Vigo, 36206
SpainSite Not Available
GSK Investigational Site
Zaragoza, 50009
SpainSite Not Available
GSK Investigational Site
Bangkok, 10330
ThailandSite Not Available
GSK Investigational Site
Khlong Luang, 12120
ThailandSite Not Available
GSK Investigational Site
Pathumthani, 12120
ThailandSite Not Available
GSK Investigational Site
Phoenix, Arizona 85006
United StatesSite Not Available
GSK Investigational Site
North Little Rock, Arkansas 72117
United StatesSite Not Available
GSK Investigational Site
Canoga Park, California 91303
United StatesSite Not Available
GSK Investigational Site
Fountain Valley, California 92708
United StatesSite Not Available
GSK Investigational Site
Pompano Beach, Florida 33060
United StatesSite Not Available
GSK Investigational Site
Fayetteville, Georgia 30214
United StatesSite Not Available
GSK Investigational Site
Thomasville, Georgia 31792
United StatesSite Not Available
GSK Investigational Site
Methuen, Massachusetts 01844
United StatesSite Not Available
GSK Investigational Site
Troy, Michigan 48084
United StatesSite Not Available
GSK Investigational Site
New York, New York 10075
United StatesSite Not Available
GSK Investigational Site
Dublin, Ohio 43016
United StatesSite Not Available
GSK Investigational Site
Austin, Texas 78746
United StatesSite Not Available
GSK Investigational Site
Santa Monica, Texas 90404
United StatesSite Not Available
GSK Investigational Site
W. Lake Hills, Texas 78746
United StatesSite Not Available
GSK Investigational Site
Springville, Utah 84663
United StatesSite Not Available
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