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A Study of TAVO101 in Atopic Dermatitis Patients
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-03-15
Primary completion: 2025-03-15
Study completion finish: 2025-09-15
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06176040
Intervention or treatment
DRUG: TAVO101
Conditions
- • Atopic Dermatitis
Find a site
Closest Location:
Royal Melbourne Hospital
Research sites nearby
Select from list below to view details:
Royal Melbourne Hospital
Parkville, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: TAVO101: High Dose
| DRUG: TAVO101
|
EXPERIMENTAL: TAVO101: Medium Dose
| DRUG: TAVO101
|
EXPERIMENTAL: TAVO101: Medium Low Dose
| DRUG: TAVO101
|
EXPERIMENTAL: TAVO101: Low Dose Control
| DRUG: TAVO101
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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). | Baseline to Week 16 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 | 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). | 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. | 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. | 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. | Baseline to Week 24 |
Cmax (Maximum observed serum concentration) of TAVO101 | To investigate the pharmacokinetics (PK) in TAVO101. | Baseline to Week 24 |
Immunogenicity of TAVO101 | To investigate the incidence of anti-drug antibodies (ADA) following dosing of TAVO101. | Baseline to Week 24 |
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