Last updated: 11/14/2025 13:00:08
A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants with Moderate to Severe Atopic DermatitisAtDventure
GSK study ID
219538
Clinicaltrials.gov ID
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 (PCFB) in the Eczema Area and Severity Index (EASI) at Week 16
Timeframe: Baseline and Week 16
Secondary outcomes:
Percent Change from Baseline (PCFB) EASI Score for GSK1070806 at Each Time Point
Timeframe: 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
Timeframe: 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
Timeframe: Baseline and up to Week 16
Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 16
Timeframe: Baseline and Week 16
Number of Participants Achieving PP-NRS Reduction of ≥4 points from Baseline at Week. 16
Timeframe: Baseline and Week 16
Number of Participants Achieving EASI Reduction of ≥50%, 90% or 100% from Baseline at Week 16
Timeframe: Baseline and Week 16
Number of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Reduction of ≥ 50% or ≥75% from Baseline at Week 16
Timeframe: Baseline and Week 16
Change from Baseline in the Body surface area (BSA) of GSK1070806 at Week 16
Timeframe: Baseline and Week 16
Change from Baseline in the SCORAD of GSK1070806 at Week 16
Timeframe: Baseline and Week 16
Change from Baseline in Patient Reported Outcomes (PRO) Measure of Skin Pain Numerical Rating Scale (SP-NRS) at Week 16
Timeframe: Baseline 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 and Week 16
Change from Baseline in PRO Measure of Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue at Week 16
Timeframe: Baseline and Week 16
Change from Baseline in PRO Measure of Brief Fatigue Inventory (BFI) - Item 3 at Week 16
Timeframe: Baseline and Week 16
Change from Baseline in PRO Measure of Patient Oriented Eczema Measure (POEM) at Week 16
Timeframe: Baseline and Week 16
Change from Baseline in PRO Measure of Dermatology Life Quality Index (DLQI) at Week 16
Timeframe: Baseline and Week 16
Change from Baseline in PRO Measure of Hospital Anxiety and Depression Scale (HADS) at Week 16
Timeframe: Baseline 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 and Week 16
Occurrences of Adverse Events (AEs), Serious AE (SAEs), and AEs of Special Interest (AESI)
Timeframe: Up to Week 28
Change from Baseline in Haematology Parameter: Haemoglobin (Hb) (Grams per Litre)
Timeframe: Baseline and Up to Week 28
Change from Baseline in Haematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, White Blood Cell (WBC), and Platelet Count (Giga Cells per Litre)
Timeframe: Baseline and Up to Week 28
Change from Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Gamma-Glutamyl Transferase (GGT), and Alkaline Phosphatase (AP) (Units per Litre)
Timeframe: Baseline and Up to Week 28
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST) (International Units per Litre)
Timeframe: Baseline and Up to Week 28
Change from Baseline in Clinical Chemistry Parameter: Total Bilirubin (Micromoles per Litre)
Timeframe: Baseline and Up to Week 28
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 (NCICTCAE)
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
Methuen, MA, United States, 01844
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fayetteville, GA, United States, 30214
Status
Study Complete
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Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
2025-23-07
Actual study completion date
2025-23-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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