Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.

Last updated: May 5, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Not Recruiting

Phase

2

Condition

Allergy

Dermatitis, Atopic

Scalp Disorders

Treatment

GSK1070806

Clinical Study ID

NCT06447506
220723
2023-508474-29-00
  • Ages > 18
  • All Genders

Study Summary

The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).

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

Total Participants: 79
Treatment Group(s): 1
Primary Treatment: GSK1070806
Phase: 2
Study Start date:
June 05, 2024
Estimated Completion Date:
July 29, 2025

Connect with a study center

  • GSK Investigational Site

    Caba, Buenos Aires C1055AAO
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1207AAP
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires, C1181ACH
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma De Bueno, C1056ABI
    Argentina

    Site Not Available

  • GSK Investigational Site

    Cordoba, X5000AAW
    Argentina

    Site Not Available

  • GSK Investigational Site

    Mendoza, 5500
    Argentina

    Site Not Available

  • GSK Investigational Site

    Rosario, S2002
    Argentina

    Site Not Available

  • GSK Investigational Site

    Pleven, 5800
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Sofia, 1510
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • GSK Investigational Site

    Markham, Ontario L3P1X2
    Canada

    Site Not Available

  • GSK Investigational Site

    Barrie,
    Canada

    Site Not Available

  • GSK Investigational Site

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • GSK Investigational Site

    Beijing, 100044
    China

    Site Not Available

  • GSK Investigational Site

    Chongqing, 400016
    China

    Site Not Available

  • GSK Investigational Site

    Fu Zhou, 350014
    China

    Site Not Available

  • GSK Investigational Site

    Fuzhou, 350014
    China

    Site Not Available

  • GSK Investigational Site

    Guangzhou,
    China

    Site Not Available

  • GSK Investigational Site

    Hangzhou, 310000
    China

    Site Not Available

  • GSK Investigational Site

    Shanghai,
    China

    Site Not Available

  • GSK Investigational Site

    Yinchuan,
    China

    Site Not Available

  • GSK Investigational Site

    Yiwu City, 322000
    China

    Site Not Available

  • GSK Investigational Site

    Pardubice,
    Czechia

    Site Not Available

  • GSK Investigational Site

    Prague, 10034
    Czechia

    Site Not Available

  • GSK Investigational Site

    Praha,
    Czechia

    Site Not Available

  • GSK Investigational Site

    Praha 2, 128 08
    Czechia

    Site Not Available

  • GSK Investigational Site

    La Rochelle Cedex 1, 17019
    France

    Site Not Available

  • GSK Investigational Site

    Nice, 06200
    France

    Site Not Available

  • GSK Investigational Site

    Paris cedex 10, 75475
    France

    Site Not Available

  • GSK Investigational Site

    Berlin, 10789
    Germany

    Site Not Available

  • GSK Investigational Site

    Essen, 45122
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg, 22391
    Germany

    Site Not Available

  • GSK Investigational Site

    Kiel, 24105
    Germany

    Site Not Available

  • GSK Investigational Site

    Muenster, 48149
    Germany

    Site Not Available

  • GSK Investigational Site

    Athens,
    Greece

    Site Not Available

  • GSK Investigational Site

    Thessaloniki, 546 43
    Greece

    Site Not Available

  • GSK Investigational Site

    Bari, 70124
    Italy

    Site Not Available

  • GSK Investigational Site

    Bologna, 40138
    Italy

    Site Not Available

  • GSK Investigational Site

    Firenze,
    Italy

    Site Not Available

  • GSK Investigational Site

    Modena, 41124
    Italy

    Site Not Available

  • GSK Investigational Site

    Roma, 00128
    Italy

    Site Not Available

  • GSK Investigational Site

    Chiba, 272-0033
    Japan

    Site Not Available

  • GSK Investigational Site

    Fukuoka, 812-8582
    Japan

    Site Not Available

  • GSK Investigational Site

    Gunma, 370-0829
    Japan

    Site Not Available

  • GSK Investigational Site

    Hokkaido, 080-0013
    Japan

    Site Not Available

  • GSK Investigational Site

    Kanagawa, 211-0063
    Japan

    Site Not Available

  • GSK Investigational Site

    Osaka, 593-8324
    Japan

    Site Not Available

  • GSK Investigational Site

    Saitama, 343-8555
    Japan

    Site Not Available

  • GSK Investigational Site

    Ansan, 15355
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Gyeonggi-do, 15355
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Seoul, 04763
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Durango., Durango 34000
    Mexico

    Site Not Available

  • GSK Investigational Site

    Chihuahua, 31000
    Mexico

    Site Not Available

  • GSK Investigational Site

    Durango, 34000
    Mexico

    Site Not Available

  • GSK Investigational Site

    Guadalajara, 44628
    Mexico

    Site Not Available

  • GSK Investigational Site

    Monterrey, 64718
    Mexico

    Site Not Available

  • GSK Investigational Site

    Ciudad de Panama, 7099
    Panama

    Site Not Available

  • GSK Investigational Site

    Chojnice, 89-600
    Poland

    Site Not Available

  • GSK Investigational Site

    Elblag, 82-300
    Poland

    Site Not Available

  • GSK Investigational Site

    Katowice, 40-600
    Poland

    Site Not Available

  • GSK Investigational Site

    Poznan, 60-569
    Poland

    Site Not Available

  • GSK Investigational Site

    Szczecin, 70-332
    Poland

    Site Not Available

  • GSK Investigational Site

    Warsaw, 03-291
    Poland

    Site Not Available

  • GSK Investigational Site

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • GSK Investigational Site

    Alicante, 03010
    Spain

    Site Not Available

  • GSK Investigational Site

    COrdoba, 14004
    Spain

    Site Not Available

  • GSK Investigational Site

    Córdoba, 14004
    Spain

    Site Not Available

  • GSK Investigational Site

    Granada, 18016
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28222
    Spain

    Site Not Available

  • GSK Investigational Site

    Valencia, 46026
    Spain

    Site Not Available

  • GSK Investigational Site

    Vigo, 36206
    Spain

    Site Not Available

  • GSK Investigational Site

    Zaragoza, 50009
    Spain

    Site Not Available

  • GSK Investigational Site

    Bangkok, 10330
    Thailand

    Site Not Available

  • GSK Investigational Site

    Khlong Luang, 12120
    Thailand

    Site Not Available

  • GSK Investigational Site

    Pathumthani, 12120
    Thailand

    Site Not Available

  • GSK Investigational Site

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • GSK Investigational Site

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • GSK Investigational Site

    Canoga Park, California 91303
    United States

    Site Not Available

  • GSK Investigational Site

    Fountain Valley, California 92708
    United States

    Site Not Available

  • GSK Investigational Site

    Pompano Beach, Florida 33060
    United States

    Site Not Available

  • GSK Investigational Site

    Fayetteville, Georgia 30214
    United States

    Site Not Available

  • GSK Investigational Site

    Thomasville, Georgia 31792
    United States

    Site Not Available

  • GSK Investigational Site

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • GSK Investigational Site

    Troy, Michigan 48084
    United States

    Site Not Available

  • GSK Investigational Site

    New York, New York 10075
    United States

    Site Not Available

  • GSK Investigational Site

    Dublin, Ohio 43016
    United States

    Site Not Available

  • GSK Investigational Site

    Austin, Texas 78746
    United States

    Site Not Available

  • GSK Investigational Site

    Santa Monica, Texas 90404
    United States

    Site Not Available

  • GSK Investigational Site

    W. Lake Hills, Texas 78746
    United States

    Site Not Available

  • GSK Investigational Site

    Springville, Utah 84663
    United States

    Site Not Available

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