Clinical trial NCT06447506: Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.
Official title: Long-Term Extension Study (AtDvance) to Evaluate the Safety and Efficacy of GSK1070806 in Participants With Moderate to Severe Atopic Dermatitis.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Dermatitis, Atopic
Keywords: Atopic dermatits
Dermatitis
Eczema
GSK1070806
Safety
Efficacy
Immune system Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2024-06-07
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Number of participants with Adverse event (AE)
timeFrame: Up to Week 280 (End of study [EoS])
measure: Number of participants with AE leading to discontinuation of GSK1070806
timeFrame: Up to Week 280 (EoS)
measure: Number of participants with Serious adverse event (SAE)
timeFrame: Up to Week 280 (EoS)
measure: Number of participants with adverse event of special interest (AESI)
timeFrame: Up to Week 280 (EoS)
Secondary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: North Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Canoga Park
country: United States
facility: GSK Investigational Site
state: California
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Pompano Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Thomasville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Troy
country: United States
facility: GSK Investigational Site
state: Michigan
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Dublin
country: United States
facility: GSK Investigational Site
state: Ohio
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Santa Monica
country: United States
facility: GSK Investigational Site
state: Texas
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autonoma De Bueno
country: Argentina
facility: GSK Investigational Site
city: Cordoba
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: Rosario
country: Argentina
facility: GSK Investigational Site
city: Pleven
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Markham
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Barrie
country: Canada
facility: GSK Investigational Site
city: Chongqing
country: China
facility: GSK Investigational Site
city: Hangzhou
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Prague
country: Czechia
facility: GSK Investigational Site
city: Praha
country: Czechia
facility: GSK Investigational Site
city: La Rochelle Cedex 1
country: France
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Muenster
country: Germany
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Gunma
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Ansan
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
city: Ciudad de Panama
country: Panama
facility: GSK Investigational Site
city: Elblag
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Szczecin
country: Poland
facility: GSK Investigational Site
city: COrdoba
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Vigo
country: Spain
facility: GSK Investigational Site
Study officials:
References: