A Study of TAVO101 in Atopic Dermatitis Patients

NCT06176040 | Active Not Recruiting Phase 2

• 1 other identifier: 59870004
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Eczema; TAVO101

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Proportion of Patients With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16

  Baseline to Week 16

• Proportion of patients who achieve a 75% Reduction From Baseline in Eczema Area and Severity (EASI 75) at Week 16

  Baseline to Week 16

• Change from Baseline in Scoring Atopic Dermatitis (SCORAD) at Week 16

  Baseline to Week 16

• Change from Baseline of Pruritus Numerical Rating Scale (NRS) at Week 16

  Baseline to Week 16

• Incidence of Treatment Emergent Adverse Events (TEAES) from Baseline to Week 24

  Baseline to Week 24

Study Arms (4)

TAVO101: High Dose

EXPERIMENTAL

TAVO101 IV Infusion given as loading dose, every 2 months (Q2M), every 3 months (Q3M).

Drug: TAVO101

TAVO101: Medium Dose

EXPERIMENTAL

TAVO101 IV Infusion given as loading dose and Q3M.

Drug: TAVO101

TAVO101: Medium Low Dose

EXPERIMENTAL

TAVO101 IV Infusion given as loading dose and Q2M.

Drug: TAVO101

TAVO101: Low Dose Control

EXPERIMENTAL

TAVO101 IV Infusion given as loading dose and Q2M.

Drug: TAVO101

Interventions

TAVO101 DRUG

TAVO101 IV Infusion.

TAVO101: High Dose; TAVO101: Low Dose Control; TAVO101: Medium Dose; TAVO101: Medium Low Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 to 75 years old
• Body weight range of ≥ 50 kg and ≤ 110 kg, inclusive, and a body mass index (BMI) ≥ 18.0 and ≤ 31.0 kg/m2
• A diagnosis of chronic AD and has been present for at least 6 months before the screening visit.
• AD Diagnosis confirmed by the Eichenfield revised criteria of Hannifin and Rajka at the screening visit.
• All the following conditions must be met to fit the Severe AD classification:
• ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits.
• Eczema Area and Severity Index (EASI) score ≥ 11 to be considered moderate AD and ≥16 to be considered severe AD at the screening and baseline visits.
• Investigator's Global Assessment (IGA) score ≥3 at the screening and baseline visits.
• Serum IgE concentration ≥150 kU/L at the screening visit.
• History of intolerant or inadequate response to a stable (1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 12 months before the screening visit.
• Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 7 days before randomization.
• No clinically significant abnormality on the basis of medical/medication history or physical examination.
• Willing and able to comply with clinic visits and study-related procedures.
• Patient able to read and understand, and willing to sign the informed consent form (ICF).
• Females of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective contraception from enrollment and must agree to continue using such precautions through to study end. Females of childbearing potential are defined as those who are not surgically sterile or post-menopausal. A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.

You may not qualify if:

• Active dermatologic conditions, which may confound the AD diagnosis or treatment assessment.
• Known active allergic or irritant contact dermatitis.
• Systemic treatment for AD with an immunosuppressive / immunomodulating substance within 4 weeks prior to the baseline visit, e.g., azathioprine, methotrexate, cyclosporine, mycophenolate-mofetil, tacrolimus, interferon-γ, or phototherapy (narrow band ultraviolet B \[NBUVB\], ultraviolet B \[UVB\], ultraviolet A1 \[UVA1\], psoralen + ultraviolet A \[PUVA\]).)
• Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor, topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), and other topical AD treatments within 2 weeks before the baseline visit.
• Treatment of AD with a medical device (eg, Atopiclair®, MimyX®, Epicerum®, Cerave®, etc) within 1 week before the baseline visit.
• Treatment with allergen immunotherapy within 6 months before the baseline visit.
• Patients with severe respiratory or autoimmune diseases that require chronic systemic corticosteroid or immuno-suppressive therapies for disease management.
• Chronic or acute infection requiring treatment with oral or IV antibiotics, anti-virals, anti-parasitics, anti-protozoals, or anti-fungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit.
• Treatment with any marketed or investigational biologic agent within 3 months or 5 half-lives prior to baseline, whichever is longer; Or receipt of any investigational non-biologic agent within 3 months or 5 half-lives prior to baseline, whichever is longer.
• Patients who have received a live or attenuated vaccine within 8 weeks prior to baseline. Receipt of inactive/killed vaccinations (eg, inactive influenza) is allowed provided they are not administered within 1 week before/after any study visit.
• Positive hepatitis B surface antigen or hepatitis C virus antibody serology. Patients with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll.
• A positive human immunodeficiency (HIV) virus test at screening or patient taking antiretroviral medications.
• Diagnosis of a helminth parasitic infection within 6 months prior to screening that has not been treated with, or has failed to respond to standard of care therapy.
• Patients who, in the opinion of the investigator, have a positive Quanti FERON tuberculosis Gold (QFT-G) test for tuberculosis (TB) during screening or have evidence of active treated or untreated TB. Patients with an indeterminate QFT-G result may be enrolled if they have all of the following: a). No symptoms of TB; b) No known exposure to a case of active TB; c) No evidence of active TB on chest radiograph within 3 months prior to baseline. Patients with an indeterminate QFT-G result will have repeat QFT-G testing at Week 12.
• History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success ≥12 months prior to screening or other malignancies treated with apparent success ≥5 years prior to screening.

Sponsors & Collaborators

• Tavotek Biotherapeutics: lead

Study Sites (2)

Royal Melbourne Hospital

Parkville, Victoria, 3052, Australia

Location

Optimal Clinical Trials

Auckland, New Zealand

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Penelope Montgomery, MD

  Optimal Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: December 19, 2023
• Study Start: March 15, 2024
• Primary Completion: March 15, 2025
• Study Completion: June 15, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); NZ (1)