This is a Phase 2 pilot study to examine the preliminary efficacy, safety and PK of TAVO101 in adult patients with moderate and severe AD.
This is a Phase 2 pilot study to examine the preliminary efficacy, safety and PK of TAVO101 in adult patients with moderate and severe AD. The total treatment and observation period is 24 weeks in duration of which the last dose of drug will be given by Week 16, leaving the last 8 weeks as an extra period for safety monitoring. Approximately 20 patients will be randomized in a 1:1:1:1 ratio to receive intravenous treatment of TAVO101 in 4 different dosing schemes. TAVO101 in 210-420 mg flat dose administered every 4 to 12 weeks will be tested to examine the preliminary effect of different dose and dosing interval in managing atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
TAVO101 IV Infusion.
Royal Melbourne Hospital
Parkville, Victoria, Australia
Optimal Clinical Trials
Auckland, New Zealand
Proportion of patients who achieve a 50% Reduction From Baseline in Eczema Area and Severity (EASI 50) at Week 16
The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification).
Time frame: Baseline to Week 16
Proportion of Patients With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
The IGA allows investigators to assess overall disease severity at 1 given time point and consists of a 6-point severity scale from clear to severe disease 0 = clear 1. = almost clear 2. = mild disease 3. = moderate disease 4. = severe disease 5. = very severe disease
Time frame: Baseline to Week 16
Proportion of patients who achieve a 75% Reduction From Baseline in Eczema Area and Severity (EASI 75) at Week 16
The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification).
Time frame: Baseline to Week 16
Change from Baseline in Scoring Atopic Dermatitis (SCORAD) at Week 16
The SCORAD is a clinical tool for assessing the severity (ie, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with subjective symptoms (Kunz et al, 1997). The total score ranges from 0 to 103, with higher values indicating more severe disease. A negative change from baseline indicates an improvement in severity of disease.
Time frame: Baseline to Week 16
Change from Baseline of Pruritus Numerical Rating Scale (NRS) at Week 16
The Peak Pruritus NRS is a single-item scale used by patients to rate itch severity in moderate-to-severe atopic dermatitis. It ranges from 0 (no itch) to 10 (worst imaginable itch), with a significant response defined as a 2-4 point change.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline to Week 16
Incidence of Treatment Emergent Adverse Events (TEAES) from Baseline to Week 24
To investigate the safety and tolerability of TAVO101 in AD patients.
Time frame: Baseline to Week 24
Cmax (Maximum observed serum concentration) of TAVO101
To investigate the pharmacokinetics (PK) in TAVO101.
Time frame: Baseline to Week 24
Immunogenicity of TAVO101
To investigate the incidence of anti-drug antibodies (ADA) following dosing of TAVO101.
Time frame: Baseline to Week 24