Clinical trial NCT05999799: A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Dermatitis, Atopic
Keywords: Dermatitis
Atopic
GSK1070806
219538
Eczema
Skin Diseases
Safety
Efficacy
Immune System Diseases
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a dose finding, placebo-controlled study where participants will be randomized to receive either GSK1070806 or placebo.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change from Baseline (PCFB) in the Eczema Area and Severity Index (EASI) at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Percent Change from Baseline (PCFB) EASI Score for GSK1070806 at Each Time Point
timeFrame: Baseline and up to Week 16
measure: Number of Participants Achieving EASI Reduction of Greater than or Equal to (≥) 75 Percent (%) from Baseline at Week 16
timeFrame: Baseline and Week 16
measure: 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
measure: Change from Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants Achieving PP-NRS Reduction of ≥4 points from Baseline at Week. 16
timeFrame: Baseline and Week 16
measure: Number of Participants Achieving EASI Reduction of ≥50%, 90% or 100% from Baseline at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Reduction of ≥ 50% or ≥75% from Baseline at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in the Body surface area (BSA) of GSK1070806 at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in the SCORAD of GSK1070806 at Week 16
timeFrame: Baseline and Week 16
measure: 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
measure: 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
measure: Change from Baseline in PRO Measure of Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in PRO Measure of Brief Fatigue Inventory (BFI) - Item 3 at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in PRO Measure of Patient Oriented Eczema Measure (POEM) at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in PRO Measure of Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in PRO Measure of Hospital Anxiety and Depression Scale (HADS) at Week 16
timeFrame: Baseline and Week 16
measure: 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
measure: Occurrences of Adverse Events (AEs), Serious AE (SAEs), and AEs of Special Interest (AESI)
timeFrame: Up to Week 28
measure: Change from Baseline in Haematology Parameter: Haemoglobin (Hb) (Grams per Litre)
timeFrame: Baseline and Up to Week 28
measure: 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
measure: 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
measure: Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST) (International Units per Litre)
timeFrame: Baseline and Up to Week 28
measure: Change from Baseline in Clinical Chemistry Parameter: Total Bilirubin (Micromoles per Litre)
timeFrame: Baseline and Up to Week 28
measure: 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
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: North Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Canoga Park
country: United States
facility: GSK Investigational Site
state: California
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Oceanside
country: United States
facility: GSK Investigational Site
state: California
city: Homestead
country: United States
facility: GSK Investigational Site
state: Florida
city: Pompano Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Northridge
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facility: GSK Investigational Site
state: Georgia
city: Thomasville
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facility: GSK Investigational Site
state: Georgia
city: Chicago
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facility: GSK Investigational Site
state: Illinois
city: Troy
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facility: GSK Investigational Site
state: Michigan
city: New York
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facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Dublin
country: United States
facility: GSK Investigational Site
state: Ohio
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Santa Monica
country: United States
facility: GSK Investigational Site
state: Texas
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Capital Federal
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autonoma De Bueno
country: Argentina
facility: GSK Investigational Site
city: Cordoba
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: Rosario
country: Argentina
facility: GSK Investigational Site
city: Pleven
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Kelowna
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Barrie
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Markham
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Quebec
country: Canada
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Chongqing
country: China
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city: Fuzhou
country: China
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city: Guangzhou
country: China
facility: GSK Investigational Site
city: Hangzhou
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Yinchuan
country: China
facility: GSK Investigational Site
city: Yiwu City
country: China
facility: GSK Investigational Site
city: Pardubice
country: Czechia
facility: GSK Investigational Site
city: Prague
country: Czechia
facility: GSK Investigational Site
city: Praha
country: Czechia
facility: GSK Investigational Site
city: Praha
country: Czechia
facility: GSK Investigational Site
city: La Rochelle Cedex 1
country: France
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city: Nice
country: France
facility: GSK Investigational Site
city: Paris Cedex 10
country: France
facility: GSK Investigational Site
city: Berlin
country: Germany
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city: Essen
country: Germany
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city: Hamburg
country: Germany
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city: Kiel
country: Germany
facility: GSK Investigational Site
city: Muenster
country: Germany
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Bari
country: Italy
facility: GSK Investigational Site
city: Bologna
country: Italy
facility: GSK Investigational Site
city: Firenze
country: Italy
facility: GSK Investigational Site
city: Modena
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Gunma
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Ansan
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
city: Monterrey
country: Mexico
facility: GSK Investigational Site
city: Ciudad de Panama
country: Panama
facility: GSK Investigational Site
city: Chojnice
country: Poland
facility: GSK Investigational Site
city: Elblag
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Szczecin
country: Poland
facility: GSK Investigational Site
city: Warsaw
country: Poland
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: COrdoba
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Vigo
country: Spain
facility: GSK Investigational Site
city: Zaragoza
country: Spain
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Pathumthani
country: Thailand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: