TK-042 Phase III Clinical Study A Double-blind, Parallel-group Phase III Study in Pediatric patients with Chronic Urticaria

JRCT ID: jRCT2031240403

Registered date:15/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Chronic urticaria
• Date of first enrollment: 02/12/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Placebo or TK-042 administered orally as 1 tablet once daily for 1 week

Outcome(s)

• Primary Outcome: Change from baseline in UAS7(Urticaria Actively Score 7)

Key inclusion & exclusion criteria

• Age minimum: >= 7age old
• Age maximum: < 12age old
• Gender: Both

Include criteria

- >= 7 to < 12 years of age.
- Chronic urticaria for over 6 weeks

Exclude criteria

- With the primary diagnosis of stimulus-inducible urticaria (e.g. physical urticaria [cold , solar or heat, etc.], cholinergic urticaria, and contact urticaria).
- Have concominant skin disorders which Principal/sub-investigator judges to afffect the efficacy evaluation.
- With uncontrolled mild to moderate bronchial asthma (those who require injectable, oral, or inhaled steroid medications), or with severe bronchial asthma.
- Have history of hypersensitivity to antihistamine drugs or any ingredients of investigational drugs.
- Currently undergoing allergen immunotherapy such as sublingual immunotherapy or have undergone such therapy within the past 3 years prior to screening.
- Have severe hepatobiliary disorders.
- Have severe renal or urinary disorders.

Related Information

• Primary Sponsor: Nishiyama Kenichi