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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06176040




Registration number
NCT06176040
Ethics application status
Date submitted
10/12/2023
Date registered
19/12/2023

Titles & IDs
Public title
A Study of TAVO101 in Atopic Dermatitis Patients
Scientific title
A Pilot Phase 2A Study to Examine the Preliminary Efficacy, Safety and PK of TAVO101 in Patients With Severe Atopic Dermatitis (AD)
Secondary ID [1] 0 0
59870004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAVO101

Experimental: TAVO101: High Dose - TAVO101 IV Infusion given as loading dose, every 2 months (Q2M), every 3 months (Q3M).

Experimental: TAVO101: Medium Dose - TAVO101 IV Infusion given as loading dose and Q3M.

Experimental: TAVO101: Medium Low Dose - TAVO101 IV Infusion given as loading dose and Q2M.

Experimental: TAVO101: Low Dose Control - TAVO101 IV Infusion given as loading dose and Q2M.


Treatment: Drugs: TAVO101
TAVO101 IV Infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients who achieve a 50% Reduction From Baseline in Eczema Area and Severity (EASI 50) at Week 16
Timepoint [1] 0 0
Baseline to Week 16
Secondary outcome [1] 0 0
Proportion of Patients With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
Timepoint [1] 0 0
Baseline to Week 16
Secondary outcome [2] 0 0
Proportion of patients who achieve a 75% Reduction From Baseline in Eczema Area and Severity (EASI 75) at Week 16
Timepoint [2] 0 0
Baseline to Week 16
Secondary outcome [3] 0 0
Change from Baseline in Scoring Atopic Dermatitis (SCORAD) at Week 16
Timepoint [3] 0 0
Baseline to Week 16
Secondary outcome [4] 0 0
Change from Baseline of Pruritus Numerical Rating Scale (NRS) at Week 16
Timepoint [4] 0 0
Baseline to Week 16
Secondary outcome [5] 0 0
Incidence of Treatment Emergent Adverse Events (TEAES) from Baseline to Week 24
Timepoint [5] 0 0
Baseline to Week 24
Secondary outcome [6] 0 0
Cmax (Maximum observed serum concentration) of TAVO101
Timepoint [6] 0 0
Baseline to Week 24
Secondary outcome [7] 0 0
Immunogenicity of TAVO101
Timepoint [7] 0 0
Baseline to Week 24

Eligibility
Key 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 >16 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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-?, 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tavotek Biotherapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Penelope Montgomery, MD
Address 0 0
Optimal Clinical Trials
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Isa Fung, MPH, MBA
Address 0 0
Country 0 0
Phone 0 0
267-405-9426
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06176040