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TERMINATED

NCT05999799

PHASE2

A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study is parallel group, placebo-controlled dose-ranging study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of GSK1070806 in adult participants with moderate to severe Atopic Dermatitis (AtD), who have previously been treated with medicated topical treatments or a biologic therapy.

Official title: A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Dose Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GSK1070806 SC Injection in Adult Participants With Moderate to Severe Atopic Dermatitis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

161

Start Date

2023-11-16

Completion Date

2025-07-23

Last Updated

2026-06-03

Healthy Volunteers

Conditions

Dermatitis, Atopic

Interventions

DRUG

GSK1070806

GSK1070806 will be administered.

DRUG

Placebo

Placebo will be administered.

Inclusion Criteria: * Adult participants 18 years to 75 years of age * Participants with: * AtD defined by the AAD Consensus Criteria. * Diagnosis of AtD ≥1 year. * An IGA score ≥3. * AtD involvement of ≥10% body surface area (BSA). * EASI score ≥16 * Baseline pruritus numerical rating scale average score for maximum intensity of at least 3. * Participants may have had exposure to 1 biologic therapy meeting at least 1 of the following conditions: * Participants who stopped treatment due to non-response, partial response, loss of efficacy. * Participants who stopped treatment due to intolerance or AEs. * Participant with a recent history less than or equal to (≤6) months prior to the Screening visit) of inadequate response to a stable regimen of prescription topical medication. * Participants for whom prescription topical medications are not tolerated. * Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical study Exclusion Criteria: * Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, anti-protozoal, or antifungals within 4 weeks before the Screening visit or anytime between the Screening and Baseline visits. * Superficial skin infections within 1 week before the Screening visit or active infections (including localized infections), or history of recurrent infections (excluding recurrent fungal infections of the nail bed) * Known, pre-existing or suspected parasitic infection within 6 months before the Screening visit. * Symptomatic herpes zoster within 3 months prior to screening * Uncontrolled hypertension. * Current or chronic history of liver disease or known hepatic or biliary abnormalities. * Known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgment. * Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years * Breast cancer within the past 10 years. * History or presence of significant medical illness including but not limited to cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurological, or psychiatric disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments. * Previously treated with any oral Janus Kinase inhibitor (JAKi) or other kinase inhibitors, experimental or approved. * Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma. * Presence of Hepatitis B surface antibody (HBsAg) or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention. * Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention. * Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention. * Positive HIV antibody test. * Evidence of active or latent TB as documented by medical history, examination, and TB testing with a positive QuantiFERON test at initial Screening visit. * Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Locations (89)

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

North Little Rock, Arkansas, United States

GSK Investigational Site

Canoga Park, California, United States

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

Northridge, California, United States

GSK Investigational Site

Oceanside, California, United States

GSK Investigational Site

Santa Monica, California, United States

GSK Investigational Site

Homestead, Florida, United States

GSK Investigational Site

Oakland Park, Florida, United States

GSK Investigational Site

Fayetteville, Georgia, United States

GSK Investigational Site

Thomasville, Georgia, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Troy, Michigan, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Dublin, Ohio, United States

GSK Investigational Site

West Lake Hills, Texas, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Capital Federal, Argentina

GSK Investigational Site

Ciudad Autonoma de Bueno, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Pleven, Bulgaria

GSK Investigational Site

Sofia, Bulgaria

GSK Investigational Site

Sofia, Bulgaria

GSK Investigational Site

Kelowna, British Columbia, Canada

GSK Investigational Site

Barrie, Ontario, Canada

GSK Investigational Site

London, Ontario, Canada

GSK Investigational Site

Markham, Ontario, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Beijing, China

GSK Investigational Site

Chongqing, China

GSK Investigational Site

Fuzhou, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Hangzhou, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Yinchuan, China

GSK Investigational Site

Yiwu, China

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

La Rochelle, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Hamburg, Germany

GSK Investigational Site

Münster, Germany

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Bari, Italy

GSK Investigational Site

Bologna, Italy

GSK Investigational Site

Florence, Italy

GSK Investigational Site

Modena, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Roma, Italy

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, Japan

GSK Investigational Site

Chihuahua City, Mexico

GSK Investigational Site

Durango, Mexico

GSK Investigational Site

Guadalajara, Mexico

GSK Investigational Site

Monterrey, Mexico

GSK Investigational Site

Panama City, Panama

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, Poland

GSK Investigational Site

Ansan, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Alicante, Spain

GSK Investigational Site

Córdoba, Spain

GSK Investigational Site

Granada, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Vigo, Spain

GSK Investigational Site

Zaragoza, Spain

GSK Investigational Site

Bangkok, Thailand

GSK Investigational Site

Pathum Thani, Thailand

Clinical Research Directory

A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (89)