A dose finding study to investigate the safety and effectiveness of GSK1070806 in adult participants with moderate to severe atopic dermatitis

JRCT ID: jRCT2071230084

Registered date:07/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic dermatitis
• Date of first enrollment: 12/12/2023
• Target sample size: 175
• Countries of recruitment: argentina,Japan,bulgaria,Japan,canada,Japan,china,Japan,czechia,Japan,france,Japan,germany,Japan,greece,Japan,italy,Japan,korea,Japan,mexico,Japan,panama,Japan,poland,Japan,spain,Japan,thailand,Japan,united states,Japan
• Study type: Interventional

Intervention(s)

Drug: GSK1070806
GSK1070806 will be administered.
Drug: Placebo
Placebo will be administered.

Outcome(s)

• Primary Outcome: Percent change from baseline (PCFB) in the EASI to Week 16.

Secondary Outcome

PCFB in the EASI at each time point.
Achieving EASI Reduction of >-75% from Baseline at Week 16
Achieving IGA score of 0 or 1 at Week 16
Change from baseline (CFB) in PP-NRS at Week 16
Achieving PP-NRS Reduction of >-4 points from Baseline at Week 16
Achieving EASI Reduction of >-50%/90%/100% from Baseline at Week 16.
Achieving SCORAD Reduction of >-50%/75% from Baseline at Week 16.
CFB to Week 16 for the following measures:
-BSA
-SCORAD
CFB to Week 16 for the following PRO measures:
-Skin pain numerical rating scale (SP-NRS)
-PROMIS-Sleep disturbance 8b
-FACIT-Fatigue
-BFI-item 3
-POEM
-DLQI
-HADS
-WPAI-AD
Occurrence of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)
Change from baseline in key laboratory parameters.
Occurrence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade >-3
hematological/clinical chemistry abnormalities.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.
AtD Medications:
Biologic experienced participants: may have had exposure to 1 biologic therapy such as, dupilumab, tralokinumab or lebrikizumab. Such participants must meet, at least, 1 of the following conditions:
-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.
-Participants who stopped treatment due to cost or loss of access.
or
Biologic naive participants: who in addition to an inadequate response to optimization of non-pharmacological measures such as moisturizers, must meet at least 1 of the following conditions:
-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

Exclude 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)
-Symptomatic herpes zoster within 3 months prior to screening
-Uncontrolled hypertension.
-Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
-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.

Related Information

• Primary Sponsor: Okawa Yasutoshi