Last updated: 04/01/2026 13:34:47
A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants with Moderate to Severe Atopic DermatitisAtDventure
EudraCT ID
Not applicable
EU CT Number
Trial status
Other
Other
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Percent Change from Baseline (CFB) in Eczema Area and Severity Index (EASI) Score at Week 16
Timeframe: Baseline (Day 1) and Week 16
Secondary outcomes:
Percent Change from Baseline (CFB) in EASI Score at Each Time Point
Timeframe: Baseline (Day 1), Weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16
Number of Participants Who Achieved Reduction of Greater than or Equal to (>=) 75 Percent (%) in EASI Score from Baseline at Week 16
Timeframe: Baseline (Day 1) and Week 16
Number of Participants who Achieved Investigator's Global Assessment (IGA) score of 0 or 1 and had a Reduction of >=2 points from Baseline at Week 16
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 16
Timeframe: Baseline (Day -7 to Day -1) and Week 16
Number of Participants Who Achieved Reduction of >=4 points in PP-NRS Score from Baseline at Week 16
Timeframe: Baseline (Day -7 to Day -1) and Week 16
Number of Participants Who Achieved Reduction of >=50%, >=90% or 100% in EASI Score from Baseline at Week 16
Timeframe: Baseline (Day 1) and Week 16
Number of Participants Who Achieved Reduction of >=50% or >=75% in Scoring Atopic Dermatitis (SCORAD) Score from Baseline at Week 16
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in the Body surface area (BSA) at Week 16
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in the SCORAD Score at Week 16
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in Patient Reported Outcomes (PRO) Measure of Skin Pain Numerical Rating Scale (SP-NRS) Score at Week 16
Timeframe: Baseline (Day -7 to Day -1) and Week 16
Change from Baseline in PRO Measure of Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Disturbance 8b at Week 16
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in PRO Measure of Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Score at Week 16
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in PRO Measure of Brief Fatigue Inventory (BFI) - Item 3 at Week 16
Timeframe: Baseline (Day -7 to Day -1) and Week 16
Change from Baseline in PRO Measure of Patient Oriented Eczema Measure (POEM) at Week 16
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in PRO Measure of Dermatology Life Quality Index (DLQI) Score at Week 16
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in PRO Measure of Hospital Anxiety and Depression Scale (HADS) – Anxiety subscale score at Week 16
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in PRO Measure of HADS-Depression subscale score at Week 16
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in PRO Measure of Work Productivity and Activity Impairment Questionnaire-Atopic Dermatitis (WPAI- AD) at Week 16
Timeframe: Baseline (Day 1) and Week 16
Number of participants with Adverse Events (AEs), Serious AE (SAEs), and AEs of Special Interest (AESI)
Timeframe: Up to Week 28
Change from Baseline in Hematology Parameter: Hemoglobin (Hb)
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in Hematology Parameter: Erythrocytes
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in Hematology Parameter: Hematocrit
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in Hematology Parameter: Prothrombin International Normalized Ratio
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma-Glutamyl Transferase (GGT)
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in Clinical Chemistry Parameter: Total Bilirubin, Direct Bilirubin, and Creatinine
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in Chemistry Parameters: Glucose and Urea
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in Chemistry Parameter: Albumin
Timeframe: Baseline (Day 1) and Week 16
Change from Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate
Timeframe: Baseline (Day 1) and Week 16
Number of Participants with Greater than or Equal to (>=) Grade 3 Hematological/clinical chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Timeframe: Up to Week 28
Interventions:
Enrollment:
161
Primary completion date:
2025-23-07
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)
November 2023 to July 2025
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 75 Years
Accepts healthy volunteers
No
- Adult participants 18 years to 75 years of age
- Participants with:
- 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)
Inclusion and exclusion criteria
Inclusion criteria:
- Adult participants 18 years to 75 years of age
- 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 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
Participants with:
Participants may have had exposure to 1 biologic therapy meeting at least 1 of the following conditions:
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.
Trial location(s)
Location
GSK Investigational Site
Springville, UT, Unmapped, 84663
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ciudad Autonoma de Bueno, Argentina, C1056ABI
Status
Study Complete
Location
GSK Investigational Site
North Little Rock, AR, Unmapped, 72117
Status
Study Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Other
Actual primary completion date
2025-23-07
Actual study completion date
2025-23-07
Plain language summaries
Summary of results in plain language
Available language(s): English, Bulgarian, Czech, French, German, Greek, Italian, Japanese, Korean, Polish, Chinese (Simplified), Spanish (Argentina), Spanish (Mexico), Spanish (Panama), Spanish, Spanish (United States), Thai
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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