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

NCT05999799 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: 2195382023-505414-15-00
• Study Type: interventional
• Target: 161
• Locations: 17 countries
• Sites: 89

Brief 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.

Conditions

Dermatitis, Atopic

Keywords

Dermatitis; Atopic; GSK1070806; 219538; Eczema; Skin Diseases; Safety; Efficacy; Immune System Diseases

Outcome Measures

Primary Outcomes (1)

• Percent Change from Baseline (PCFB) in the Eczema Area and Severity Index (EASI) at Week 16

  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.

  Baseline and Week 16

Secondary Outcomes (24)

• Percent Change from Baseline (PCFB) EASI Score for GSK1070806 at Each Time Point

  Baseline and up to Week 16

• Number of Participants Achieving EASI Reduction of Greater than or Equal to (≥) 75 Percent (%) from Baseline at Week 16

  Baseline and Week 16

• Number of Participants Achieving Investigator's Global Assessment (IGA) score of 0 or 1 and a Reduction from Baseline ≥ 2 Points at Week 16

  Baseline and up to Week 16

• Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 16

  Baseline and Week 16

• Number of Participants Achieving PP-NRS Reduction of ≥4 points from Baseline at Week. 16

  Baseline and Week 16

Study Arms (5)

GSK1070806 Dose 1

EXPERIMENTAL

Participants will receive GSK1070806 dose 1.

Drug: GSK1070806

GSK1070806 Dose 2

EXPERIMENTAL

Participants will receive GSK1070806 dose 2.

Drug: GSK1070806

GSK1070806 Dose 3

EXPERIMENTAL

Participants will receive GSK1070806 dose 3.

Drug: GSK1070806

GSK1070806 Dose 4

EXPERIMENTAL

Participants will receive GSK1070806 dose 4.

Drug: GSK1070806

Placebo

PLACEBO COMPARATOR

Participants will receive placebo.

Drug: Placebo

Interventions

GSK1070806 DRUG

GSK1070806 will be administered.

GSK1070806 Dose 1; GSK1070806 Dose 2; GSK1070806 Dose 3; GSK1070806 Dose 4

Placebo DRUG

Placebo will be administered.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (89)

GSK Investigational Site

Phoenix, Arizona, 85006, United States

Location

GSK Investigational Site

North Little Rock, Arkansas, 72117, United States

Location

GSK Investigational Site

Canoga Park, California, 91303, United States

Location

GSK Investigational Site

Fountain Valley, California, 92708, United States

Location

GSK Investigational Site

Northridge, California, 91325, United States

Location

GSK Investigational Site

Oceanside, California, 92056, United States

Location

GSK Investigational Site

Santa Monica, California, 90404, United States

Location

GSK Investigational Site

Homestead, Florida, 33033, United States

Location

GSK Investigational Site

Oakland Park, Florida, 33334, United States

Location

GSK Investigational Site

Fayetteville, Georgia, 30214, United States

Location

GSK Investigational Site

Thomasville, Georgia, 31792, United States

Location

GSK Investigational Site

Chicago, Illinois, 60614, United States

Location

GSK Investigational Site

Troy, Michigan, 48084, United States

Location

GSK Investigational Site

New York, New York, 10029, United States

Location

GSK Investigational Site

New York, New York, 10075, United States

Location

GSK Investigational Site

Dublin, Ohio, 43016, United States

Location

GSK Investigational Site

West Lake Hills, Texas, 78746, United States

Location

GSK Investigational Site

Buenos Aires, C1055AAO, Argentina

Location

GSK Investigational Site

Capital Federal, C1181ACH, Argentina

Location

GSK Investigational Site

Ciudad Autonoma de Bueno, C1056ABI, Argentina

Location

GSK Investigational Site

Córdoba, X5000AAW, Argentina

Location

GSK Investigational Site

Mendoza, 5500, Argentina

Location

GSK Investigational Site

Rosario, S2002, Argentina

Location

GSK Investigational Site

Pleven, 5800, Bulgaria

Location

GSK Investigational Site

Sofia, 1510, Bulgaria

Location

GSK Investigational Site

Sofia, Bulgaria

Location

GSK Investigational Site

Kelowna, British Columbia, V1Y 4N7, Canada

Location

GSK Investigational Site

Barrie, Ontario, L4M 7G1, Canada

Location

GSK Investigational Site

London, Ontario, N6H 5L5, Canada

Location

GSK Investigational Site

Markham, Ontario, L3P1X2, Canada

Location

GSK Investigational Site

Québec, Quebec, G1W 4R4, Canada

Location

GSK Investigational Site

Beijing, 100044, China

Location

GSK Investigational Site

Chongqing, 400016, China

Location

GSK Investigational Site

Fuzhou, 350014, China

Location

GSK Investigational Site

Guangzhou, China

Location

GSK Investigational Site

Hangzhou, 310006, China

Location

GSK Investigational Site

Shanghai, 200025, China

Location

GSK Investigational Site

Shanghai, China

Location

GSK Investigational Site

Yinchuan, China

Location

GSK Investigational Site

Yiwu, 322000, China

Location

GSK Investigational Site

Prague, 10034, Czechia

Location

GSK Investigational Site

Prague, 128 08, Czechia

Location

GSK Investigational Site

Prague, Czechia

Location

GSK Investigational Site

La Rochelle, 17019, France

Location

GSK Investigational Site

Paris, 75475, France

Location

GSK Investigational Site

Berlin, 10789, Germany

Location

GSK Investigational Site

Hamburg, 22391, Germany

Location

GSK Investigational Site

Münster, 48149, Germany

Location

GSK Investigational Site

Athens, Greece

Location

GSK Investigational Site

Bari, 70124, Italy

Location

GSK Investigational Site

Bologna, 40138, Italy

Location

GSK Investigational Site

Florence, Italy

Location

GSK Investigational Site

Modena, 41124, Italy

Location

GSK Investigational Site

Roma, 00128, Italy

Location

GSK Investigational Site

Roma, 00168, Italy

Location

GSK Investigational Site

Chiba, 272-0033, Japan

Location

GSK Investigational Site

Fukuoka, 807-8556, Japan

Location

GSK Investigational Site

Fukuoka, 812-8582, Japan

Location

GSK Investigational Site

Gunma, 370-0829, Japan

Location

GSK Investigational Site

Hokkaido, 060-0033, Japan

Location

GSK Investigational Site

Hokkaido, 080-0013, Japan

Location

GSK Investigational Site

Kanagawa, 211-0063, Japan

Location

GSK Investigational Site

Osaka, 583-8588, Japan

Location

GSK Investigational Site

Osaka, 593-8324, Japan

Location

GSK Investigational Site

Saitama, 343-8555, Japan

Location

GSK Investigational Site

Chihuahua City, 31000, Mexico

Location

GSK Investigational Site

Durango, 34000, Mexico

Location

GSK Investigational Site

Guadalajara, 44628, Mexico

Location

GSK Investigational Site

Monterrey, 64718, Mexico

Location

GSK Investigational Site

Panama City, 7099, Panama

Location

GSK Investigational Site

Chojnice, 89-600, Poland

Location

GSK Investigational Site

Elblag, 82-300, Poland

Location

GSK Investigational Site

Katowice, 40-600, Poland

Location

GSK Investigational Site

Poznan, 60-569, Poland

Location

GSK Investigational Site

Szczecin, 70-332, Poland

Location

GSK Investigational Site

Warsaw, 03-291, Poland

Location

GSK Investigational Site

Ansan, 15355, South Korea

Location

GSK Investigational Site

Seoul, 03722, South Korea

Location

GSK Investigational Site

Seoul, 04564, South Korea

Location

GSK Investigational Site

Seoul, 04763, South Korea

Location

GSK Investigational Site

Seoul, 150-950, South Korea

Location

GSK Investigational Site

Alicante, 03010, Spain

Location

GSK Investigational Site

Córdoba, 14004, Spain

Location

GSK Investigational Site

Granada, 18016, Spain

Location

GSK Investigational Site

Madrid, 28222, Spain

Location

GSK Investigational Site

Vigo, 36206, Spain

Location

GSK Investigational Site

Zaragoza, 50009, Spain

Location

GSK Investigational Site

Bangkok, 10330, Thailand

Location

GSK Investigational Site

Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Immune System Diseases

Interventions

GSK1070806

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigator are blinded to study intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a dose finding, placebo-controlled study where participants will be randomized to receive either GSK1070806 or placebo.

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: November 16, 2023
• Primary Completion: July 23, 2025
• Study Completion: July 23, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

ES (6); CA (5); CZ (3); JP (10); PA (1); ME (4); DE (3); PL (6); IT (6); US (17); BU (3); CN (9); TH (2); AR (6); GR (1); FR (2); KR (5)