Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis. (AtDvance)

JRCT ID: jRCT2031240179

Registered date:21/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic dermatitis
• Date of first enrollment: 23/07/2024
• Target sample size: 24
• Countries of recruitment: Argentina,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Czechia,Japan,France,Japan,Germany,Japan,Italy,Japan,Mexico,Japan,Panama,Japan,Poland,Japan,Sout Korea,Japan,Spain,Japan,Thailand,Japan,USA,Japan
• Study type: Interventional

Intervention(s)

Drug: GSK1070806
GSK1070806 will be administered.

Outcome(s)

Primary Outcome

-Number of participants with Adverse event (AE) [Time Frame: Up to Week 280 (End of study [EoS])]
-Number of participants with AE leading to discontinuation of GSK1070806 [Time Frame: Up to Week 280 (EoS)]
-Number of participants with Serious adverse event (SAE) [Time Frame: Up to Week 280 (EoS)]
-Number of participants with adverse event of special interest (AESI) [Time Frame: Up to Week 280 (EoS)]
AESI for GSK1070806 include serious infections, opportunistic infections, serious hypersensitivity reactions and injection site reactions (ISRs).

Secondary Outcome

-Number of Participants Achieving Investigators Global Assessment (IGA) score of 0 or 1 at Week 16, 32, 48 and up to Week 280 (EoS)
-Number of participants Achieving Eczema Area and Severity Index (EASI) reduction of greater than or equal to (>=) 75 percent (%) at Week 16, 32, 48 and up to Week 280 (EoS)
-The occurrence of >=75% reduction from baseline achieving EASI 75 score at Week 16, 32, 48 and up to Week 208 (EoS) will be reported.
-Number of participants with decreased Peak Pruritus Numerical Rating Scale (PP-NRS) by >=4 points at Week 16, 32, 48 and up to Week 280 (EoS)

-Percentage of participants Achieving maintained response for IGA of 0 to 1 at Week 16, 32, 48 and up to Week 280 (EoS)
-Percentage of participants Achieving maintained response for EASI reduction to >= 75% at Week 16, 32, 48 and up to Week 280 (EoS)
-Percentage change from Baseline in EASI at week 16, 32, 48 and up to Week 280 (EoS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Participants must sign and date the consent document.
-Participants diagnosed with moderate to severe Atopic dermatitis (AtD) who have completed the qualifying Phase 2 parent study of GlaxoSmithKline (GSK's) AtD and, in their opinion, may benefit from GSK1070806.
-Be intentional and able to visit the doctor at the clinic by appointment and follow all procedures related to research studies and questionnaires (able to read and understand Patient-reported outcomes (PRO) questionnaires and be able to use electronic devices).
-The use of contraceptive methods for females should be consistent with local regulations on contraceptive methods of participants participating in clinical research programs.
-Female participants are eligible to participate in the research program if they are not pregnant or breastfeeding and meet one of the following conditions:
- It is Woman of nonchildbearing potential (WONCBP).
- It is Woman of childbearing potential (WOCBP) and uses a highly effective contraceptive method that has a failure rate less than (<) 1 percent (%) during the trial dose period and for at least 16 weeks after the last dose of the research drug. We should assess the likelihood of contraceptive failure (e.g., non-cooperation, early contraception) associated with the first dose of the drug.
-WOCBP must obtain a negative result in a highly sensitive pregnancy test (by urine or serum test, as prescribed by local regulations) before receiving the first dose of the research drug.
- If the urine test is positive, or the negative result cannot be confirmed (i.e., the result is unclear), a pregnancy test by serum test is required. In such cases, If the serum is tested, the test result is positive. Participants must be excluded from the research project.
- Additional requirements for testing pregnancy during and after exposure to the drug.
- The researcher is responsible for examining medical history, menstrual cycle history, and sexual activity in the near term. To reduce the risk of screening pregnant women who may not be detected at the beginning of pregnancy.

Exclude criteria

-Permanent discontinuation of the study drug at any time during GSK's qualifying Phase 2 AtD or a medical condition that would hinder GSK's participation in the Phase 2 219538 AtD research project.
-Participants who, during GSK's qualifying Phase 2 AtD research project, developed adverse event (AE) or Serious adverse event (SAE) based on laboratory parameters, physical examination, vital signs, Electrocardiogram (ECG), medical history, etc. Medical history, in the opinion of the researchers, suggests that if Investigational medicinal product (IMP) is continued, it may cause unnecessary risk to the participants.
-Topical medications for AtD within 1 week prior to your appointment at Day 1, such as: Topical calcineurin inhibitors (TCI)/ Topical corticosteroids (TCS), Phosphodiesterase-4 (PDE-4) and Janus activation kinase inhibitors (JAKi) for external use.
- Topical corticosteroids (TCS) (such as hydrocortisone, betamethasone)
- Topical calcineurin inhibitors (TCI) (such as tacrolimus, pimecrolimus)
- Phosphodiesterase-4 (PDE4) inhibitor for external use (e.g., crisaborole)
- JAKi for external use (e.g. ruxolitinib)
- Medications for topical use, or other herbal/traditional medicines that may affect the AtD that the participants are in.
-Participant who received systemic therapy, which is considered contraindicated, including systemic therapy used as a rescue medication for AtD, from the screening for GSK's Phase 2 AtD 219538 research project until the LTE protocol began, were unable to participate in the research project.
-Chronic uncontrolled diseases that may require immediate oral corticosteroids, such as severe uncontrolled asthma (defined as having an Asthma control questionnaire (ACQ)-5 score greater than or equal to (>=) of 1.5 or a history of asthma exacerbations. >= 2 times within the last 12 months, requiring systemic corticosteroid [oral and/or intravenous medication] or requiring a >-24-hour hospital stay)

Related Information

• Primary Sponsor: Okamasa Arisa