A Study of TAVO101 in Atopic Dermatitis Patients

A Pilot Phase 2A Study to Examine the Preliminary Efficacy, Safety and PK of TAVO101 in Patients with Moderate to Severe Atopic Dermatitis (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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: TAVO101

Detailed Description

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
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Royal Melbourne Hospital
• New Zealand
  • Auckland, New Zealand
    • Optimal Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, 18 to 75 years old
2. Body weight range of ≥ 50 kg and ≤ 110 kg, inclusive, and a body mass index (BMI) ≥ 18.0 and ≤ 31.0 kg/m2
3. A diagnosis of chronic AD and has been present for at least 6 months before the screening visit.
4. AD Diagnosis confirmed by the Eichenfield revised criteria of Hannifin and Rajka at the screening visit.

5. 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.
6. Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 7 days before randomization.
7. No clinically significant abnormality on the basis of medical/medication history or physical examination.
8. Willing and able to comply with clinic visits and study-related procedures.
9. Patient able to read and understand, and willing to sign the informed consent form (ICF).
10. 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.
11. Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms (unless surgically sterile) from Screening through 60 days after the last dose of study drug, and their partners must be willing to use a highly effective method of contraception from Screening through 60 days after the last dose of study drug.

Exclusion Criteria:

1. Active dermatologic conditions, which may confound the AD diagnosis or treatment assessment.
2. Known active allergic or irritant contact dermatitis.
3. 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]).)
4. 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.
5. Treatment of AD with a medical device (eg, Atopiclair®, MimyX®, Epicerum®, Cerave®, etc) within 1 week before the baseline visit.
6. Treatment with allergen immunotherapy within 6 months before the baseline visit.
7. Patients with severe respiratory or autoimmune diseases that require chronic systemic corticosteroid or immuno-suppressive therapies for disease management.
8. 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.
9. 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.
10. 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.
11. 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.
12. A positive human immunodeficiency (HIV) virus test at screening or patient taking antiretroviral medications.
13. 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.
14. 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.
15. 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.
16. History of anaphylaxis or severe infusion related reaction (IRR) following any biologic therapy.
17. Any clinically relevant abnormal findings in physical electrocardiogram examination, vital signs, hematology, clinical chemistry, or urinalysis during screening, which in the opinion of the investigator may compromise the patient's safety, interfere with evaluation of the study treatment or reduce the patient's ability to participate in the study. Evidence of active liver disease, including jaundice or aspartate transaminase, alanine transaminase, or alkaline phosphatase greater than twice the upper limit of normal.
18. Major surgery within 8 weeks prior to screening or planned in-patient surgery or hospitalization during the study period.
19. Use of a tanning booth/parlor within 8 weeks before the screening visit.
20. Pregnant or breast-feeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAVO101: Medium Dose; TAVO101 IV Infusion given as loading dose and Q3M.	Drug: TAVO101; TAVO101 IV Infusion.
Experimental: TAVO101: Medium Low Dose; TAVO101 IV Infusion given as loading dose and Q2M.	Drug: TAVO101; TAVO101 IV Infusion.
Experimental: TAVO101: Low Dose Control; TAVO101 IV Infusion given as loading dose and Q2M.	Drug: TAVO101; TAVO101 IV Infusion.
Experimental: TAVO101: High Dose; TAVO101 IV Infusion given as loading dose, every 2 months (Q2M), every 3 months (Q3M).	Drug: TAVO101; TAVO101 IV Infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	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 Measures

Outcome Measure	Measure Description	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; = almost clear; = mild disease; = moderate disease; = severe disease; = 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

Collaborators and Investigators

• Sponsor: Tavotek Biotherapeutics
• Investigators: Principal Investigator: Penelope Montgomery, MD, Optimal Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: December 10, 2023
• First Submitted That Met QC Criteria: December 10, 2023
• First Posted (Actual): December 19, 2023

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; Eczema; TAVO101
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: 59870004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No