Last updated: 11/14/2025 13:10:29
Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.AtDvance
GSK study ID
220723
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Other
Other
Trial overview
Official title: Long-Term Extension Study (AtDvance) to Evaluate the Safety and Efficacy of GSK1070806 in Participants with Moderate to Severe Atopic Dermatitis.
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Non-randomized
Primary outcomes:
Number of participants with Adverse event (AE)
Timeframe: Up to Week 280 (End of study [EoS])
Number of participants with AE leading to discontinuation of GSK1070806
Timeframe: Up to Week 280 (EoS)
Number of participants with Serious adverse event (SAE)
Timeframe: Up to Week 280 (EoS)
Number of participants with adverse event of special interest (AESI)
Timeframe: Up to Week 280 (EoS)
Secondary outcomes:
Number of Participants Achieving Investigators Global Assessment (IGA) score of 0 or 1 at Week 16, 32, 48 and up to Week 280 (EoS)
Timeframe: Week 16, 32, 48 and up to Week 280 (EoS)
Number of participants Achieving Eczema Area and Severity Index (EASI) reduction of greater than or equal to (>=) 75 percent (%) at Week 16, 32, 48 and up to Week 280 (EoS)
Timeframe: Week 16, 32, 48 and up to Week 280 (EoS)
Number of participants with decreased Peak Pruritus Numerical Rating Scale (PP-NRS) by >=4 points at Week 16, 32, 48 and up to Week 280 (EoS)
Timeframe: Week 16, 32, 48 and up to Week 280 (EoS)
Percentage of participants Achieving maintained response for IGA of 0 to 1 at Week 16, 32, 48 and up to Week 280 (EoS)
Timeframe: Week 16, 32, 48 and up to Week 280 (EoS)
Percentage of participants Achieving maintained response for EASI reduction to >= 75% at Week 16, 32, 48 and up to Week 280 (EoS)
Timeframe: Week 16, 32, 48 and up to Week 280 (EoS)
Percentage change from Baseline in EASI at week 16, 32, 48 and up to Week 280 (EoS)
Timeframe: Week 16, 32, 48 and up to Week 280 (EoS)
Interventions:
Enrollment:
79
Primary completion date:
2025-29-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dermatitis, Atopic
Product
GSK1070806
Collaborators
Not applicable
Study date(s)
June 2024 to July 2025
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participants must sign and date the consent document.
- Participants diagnosed with moderate to severe Atopic dermatitis (AtD) who have completed the qualifying Phase 2 parent study (NCT05999799) of GlaxoSmithKline (GSK's) AtD and, in their opinion, may benefit from GSK1070806.
- Permanent discontinuation of the study drug at any time during GSK's qualifying Phase 2 AtD (NCT05999799) or a medical condition that would hinder GSK's participation in the Phase 2 219538 (NCT05999799) AtD research project.
- Participants who, during GSK's qualifying Phase 2 (NCT05999799) AtD research project, developed adverse event (AE) or Serious adverse event (SAE) based on laboratory parameters, physical examination, vital signs, Electrocardiogram (ECG), medical history, etc. Medical history, in the opinion of the researchers, suggests that if Investigational medicinal product (IMP) is continued, it may cause unnecessary risk to the participants.
Inclusion and exclusion criteria
Inclusion criteria:
- Participants must sign and date the consent document.
- Participants diagnosed with moderate to severe Atopic dermatitis (AtD) who have completed 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 follow all procedures related to research studies and questionnaires (able to read and understand Patient-reported outcomes (PRO) questionnaires and be able to use electronic devices).
- The use of contraceptive methods for females should be consistent with local regulations on contraceptive methods of participants participating in clinical research programs.
- Female participants are eligible to participate in the research program if they are not 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 effective contraceptive method that has a failure rate less than (<) 1 percent (%) during the trial dose period and for at least 16 weeks after the last dose of the research drug. 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 urine or serum test, as prescribed by local regulations) before receiving the first dose of the research drug.
- If the urine test is positive, or the negative result cannot be confirmed (i.e., the result is unclear), a pregnancy test by serum test is required. In such cases, If the serum is tested, the test result is positive. Participants must be excluded from the research project.
- Additional requirements for testing pregnancy during and after exposure to the drug.
- The researcher is responsible for examining medical history, menstrual cycle history, and sexual activity in the near term. To reduce the risk of screening pregnant women who may not be detected at the beginning of pregnancy.
Exclusion criteria:
- Permanent discontinuation of the study drug at any time during GSK's qualifying Phase 2 AtD (NCT05999799) or a medical condition that would hinder GSK's participation in the Phase 2 219538 (NCT05999799) AtD research project.
- Participants who, during GSK's qualifying Phase 2 (NCT05999799) AtD research project, developed adverse event (AE) or Serious adverse event (SAE) based on laboratory parameters, physical examination, vital signs, Electrocardiogram (ECG), medical history, etc. Medical history, in the opinion of the researchers, suggests that if Investigational medicinal product (IMP) is continued, it may cause unnecessary risk to the participants.
- Topical medications for AtD within 1 week prior to your appointment at Day 1, such as: Topical calcineurin inhibitors (TCI)/ Topical corticosteroids (TCS), Phosphodiesterase-4 (PDE-4) and Janus activation kinase inhibitors (JAKi) for external 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 affect the 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 screening for GSK's Phase 2 AtD 219538 research project until the LTE protocol began, were unable to participate in the research project.
- Chronic uncontrolled diseases that may require immediate oral corticosteroids, such as 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 asthma exacerbations. >= 2 times within the last 12 months, requiring systemic corticosteroid [oral and/or intravenous medication] or requiring a >-24-hour hospital stay)
- Experience participating in previous/current clinical research projects.
- The participants have participated in any other clinical research studies. This is in addition to GSK's Phase 2 219538 (NCT05999799) research project.
Trial location(s)
Location
GSK Investigational Site
Phoenix, AZ, United States, 85006
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pompano Beach, FL, United States, 33334
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, TX, United States, 90404
Status
Study Complete
Location
GSK Investigational Site
Springville, UT, United States, 84663
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Austin, TX, United States, 78746
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Canoga Park, CA, United States, 91303
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ciudad Autonoma de Bueno, Argentina, C1056ABI
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, CA, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
North Little Rock, AR, United States, 72117
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fayetteville, GA, United States, 30214
Status
Study Complete
Location
GSK Investigational Site
Thomasville, GA, United States, 31792
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
2025-29-07
Actual study completion date
2025-29-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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