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Atopic DermatitisPhase 2NCT06176040

A Study of TAVO101 in Atopic Dermatitis Patients

A Phase 2 study testing TAVO101 in people with Atopic Dermatitis, run by Tavotek Biotherapeutics at 2 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
TAVO101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesin 2 countries
Study dates
15 Mar 2024to 15 Jun 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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.
  • History of anaphylaxis or severe infusion related reaction (IRR) following any biologic therapy.
  • 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.
  • Major surgery within 8 weeks prior to screening or planned in-patient surgery or hospitalization during the study period.
  • Use of a tanning booth/parlor within 8 weeks before the screening visit.
  • Pregnant or breast-feeding women.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Australia1 site

  • Royal Melbourne Hospital

    Parkville, Victoria, 3052

Other trials in Australia

New Zealand1 site

  • Optimal Clinical Trials

    Auckland

Other trials in New Zealand

About this study

Official title: 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.

Read the 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.

Being tested
TAVO101
Keywords
Atopic Dermatitis, Eczema, TAVO101
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAVO101Drug

    TAVO101 IV Infusion.

Study groups in NCT06176040
Study groupRoleWhat they receive
TAVO101: High DoseExperimentalTAVO101 IV Infusion given as loading dose, every 2 months (Q2M), every 3 months (Q3M).
Receives: Drug: TAVO101
TAVO101: Medium DoseExperimentalTAVO101 IV Infusion given as loading dose and Q3M.
Receives: Drug: TAVO101
TAVO101: Medium Low DoseExperimentalTAVO101 IV Infusion given as loading dose and Q2M.
Receives: Drug: TAVO101
TAVO101: Low Dose ControlExperimentalTAVO101 IV Infusion given as loading dose and Q2M.
Receives: Drug: TAVO101

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline to Week 16

Secondary outcomes (7)

  1. 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

    Measured: Baseline to Week 16

  2. 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).

    Measured: Baseline to Week 16

  3. 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.

    Measured: Baseline to Week 16

  4. 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.

    Measured: Baseline to Week 16

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

    To investigate the safety and tolerability of TAVO101 in AD patients.

    Measured: Baseline to Week 24

  6. Cmax (Maximum observed serum concentration) of TAVO101

    To investigate the pharmacokinetics (PK) in TAVO101.

    Measured: Baseline to Week 24

  7. Immunogenicity of TAVO101

    To investigate the incidence of anti-drug antibodies (ADA) following dosing of TAVO101.

    Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2023
  2. Study start15 Mar 2024
  3. Primary completion15 Mar 2025 (estimated)
  4. Study completion15 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06176040
Sponsor's protocol ID
59870004
Status last verified
Nov 2024
First submitted
10 Dec 2023
Last updated
18 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAVO101 in people with Atopic Dermatitis, run by Tavotek Biotherapeutics at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who achieve a 50% Reduction From Baseline in Eczema Area and Severity (EASI 50) at Week 16 (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06176040.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.

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