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

Dermatitis, Atopic Clinical Trial

— AtDvance  

Official title:

Long-Term Extension Study (AtDvance) to Evaluate the Safety and Efficacy of GSK1070806 in Participants With Moderate to Severe Atopic Dermatitis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447506
• Other study ID #: 220723
• Secondary ID: 2023-508474-29-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 4, 2024
• Est. completion date: November 7, 2029

Study information

• Verified date: May 2024
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 158
• Est. completion date: November 7, 2029
• Est. primary completion date: November 7, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• GSK1070806
Participants will receive GSK1070806.

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Caba	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Cordoba	Córdova
Argentina	GSK Investigational Site	Mendoza
Argentina	GSK Investigational Site	Rosario	Santa Fe
Bulgaria	GSK Investigational Site	Pleven
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Canada	GSK Investigational Site	Barrie	Ontario
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Markham	Ontario
Canada	GSK Investigational Site	Quebec
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Chongqing	Chongqing
China	GSK Investigational Site	Fu Zhou
China	GSK Investigational Site	Guangzhou
China	GSK Investigational Site	Hangzhou	Zhejiang
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai	Shanghai
China	GSK Investigational Site	Yinchuan
China	GSK Investigational Site	Yiwu City	Zhejiang
Czechia	GSK Investigational Site	Prague
Czechia	GSK Investigational Site	Praha
Czechia	GSK Investigational Site	Praha 2
France	GSK Investigational Site	La Rochelle cedex 1
France	GSK Investigational Site	Nice
France	GSK Investigational Site	Paris cedex 10
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Thessaloniki
Italy	GSK Investigational Site	Bari
Italy	GSK Investigational Site	Bologna	Emilia Romagna
Italy	GSK Investigational Site	Firenze
Italy	GSK Investigational Site	Modena	Emilia-Romagna
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Gunma
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Saitama
Korea, Republic of	GSK Investigational Site	Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Mexico	GSK Investigational Site	Chihuahua
Mexico	GSK Investigational Site	Durango.	Durango
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Monterrey
Panama	GSK Investigational Site	Ciudad de Panama
Poland	GSK Investigational Site	Chojnice
Poland	GSK Investigational Site	Elblag
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Szczecin
Poland	GSK Investigational Site	Warsaw
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Córdoba
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Majadahonda	Madrid
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Vigo	Pontevedra
Spain	GSK Investigational Site	Zaragoza
Thailand	GSK Investigational Site	Bangkok	Pathum Wan
Thailand	GSK Investigational Site	Khlong Luang
United States	GSK Investigational Site	Canoga Park	California
United States	GSK Investigational Site	Dublin	Ohio
United States	GSK Investigational Site	Fayetteville	Georgia
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Methuen	Massachusetts
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	North Little Rock	Arkansas
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pompano Beach	Florida
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	Springville	Utah
United States	GSK Investigational Site	Thomasville	Georgia
United States	GSK Investigational Site	Troy	Michigan
United States	GSK Investigational Site	W. Lake Hills	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Canada,  China,  Czechia,  France,  Germany,  Greece,  Italy,  Japan,  Korea, Republic of,  Mexico,  Panama,  Poland,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse event (AE)	An AE is any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product.	Up to Week 280 (End of study [EoS])
Primary	Number of participants with AE leading to discontinuation of GSK1070806	An AE leading to discontinuation of GSK1070806 will be reported.	Up to Week 280 (EoS)
Primary	Number of participants with Serious adverse event (SAE)	Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAE.	Up to Week 280 (EoS)
Primary	Number of participants with adverse event of special interest (AESI)	AESI for GSK1070806 include serious infections, opportunistic infections, serious hypersensitivity reactions and injection site reactions (ISRs).	Up to Week 280 (EoS)
Secondary	Number of Participants Achieving Investigators Global Assessment (IGA) score of 0 or 1 at Week 16, 32, 48 and up to Week 280 (EoS)	IGA for Atopic dermatitis (AtD) is a measure of overall disease severity at the time of assessment on a 5-point scale by the investigator. Where 0-clear, 1-almost clear, 2-mild disease, 3-moderate disease, and 4- severe disease. Higher score indicates severity of disease. A participant with an IGA score of 0 or 1 from baseline will be reported.	Week 16, 32, 48 and up to Week 280 (EoS)
Secondary	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)	The occurrence of >=75% reduction from baseline achieving EASI 75 score at Week 16, 32, 48 and up to Week 208 (EoS) will be reported. EASI is an internationally used classification for AtD severity and an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.	Week 16, 32, 48 and up to Week 280 (EoS)
Secondary	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)	Peak pruritus numerical rating scale (PP-NRS) is a patient reported measure of pruritus (itch) intensity assessing worst itch (in the past 24 hours). The values will be evaluated using an 11-point scale (from 0 to 10), with 0 being no itch and 10 being the worst imaginable itch.	Week 16, 32, 48 and up to Week 280 (EoS)
Secondary	Percentage of participants Achieving maintained response for IGA of 0 to 1 at Week 16, 32, 48 and up to Week 280 (EoS)	IGA for AtD is a measure of overall disease severity at the time of assessment on a 5-point scale by the investigator. Where 0-clear, 1-almost clear, 2-mild disease, 3-moderate disease, and 4- severe disease. Higher score indicates severity of disease.	Week 16, 32, 48 and up to Week 280 (EoS)
Secondary	Percentage of participants Achieving maintained response for EASI reduction to >= 75% at Week 16, 32, 48 and up to Week 280 (EoS)	The occurrence of >=75% reduction from baseline achieving EASI 75 score at Week 16, 32, 48 and up to Week 208 (EoS) will be reported. EASI is an internationally used classification for AtD severity and an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.	Week 16, 32, 48 and up to Week 280 (EoS)
Secondary	Percentage change from Baseline in EASI at week 16, 32, 48 and up to Week 280 (EoS)	EASI is an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.	Week 16, 32, 48 and up to Week 280 (EoS)