Dermatitis, AtopicPhase 1/2NCT06094179
Evaluate the Safety, Tolerability of BAT6026
A Phase 1/2 study testing Monoclonal antibody BAT6026 and sodium chloride injection in people with Dermatitis, Atopic, run by Bio-Thera Solutions at 1 site in China.
Trial summary
This is a Phase IB/IIA clinical study of BAT6026 in patients with AD. The subjects were adults with moderate to severe atopic dermatitis (AD) whose disease was not adequately controlled by prior topical medications or for which topical medications were not appropriate. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Monoclonal antibody BAT6026 and sodium chloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2023to 31 Dec 2026
- Phase
- Phase 1/2
- 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
- Voluntarily sign written informed consent and comply with the requirements of the research protocol;
- age 18-75 years old, male and female;
- According to the Hanifin-Rajka criteria, the patient was diagnosed with AD and had a history of at least 1 year;
- EASI score ≥16 during screening visit and baseline visit;
- IGA score ≥3 at screening and baseline (moderate);
- BSA involvement at screening and baseline was ≥10%;
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- Received glucocorticoids, phosphodiesterase inhibitors, or calcineurin inhibition in the 6 months prior to screening Drug, or phototherapy for AD and other local treatment options, and according to the judgment of the investigator, the local treatment response is insufficient (follow the doctor Local treatment is prescribed for at least 4 weeks or to the maximum recommended course of treatment in the product's prescribing information, whichever is shorter, which has not been achieved Is in remission or in a state of low disease activity (IGA 0 to 2), has no response or intolerance, or has a medical contraindication to the treatment, and is not suitable for the use of this local treatment;
- Steady-dose topical emollients (subjects must use investigator-recommended or investigator-approved base emollients that do not contain AD-affecting additives, such as hyaluronic acid, urea, ceramide, or filagmin) have been applied for at least 7 consecutive days prior to baseline visit and continued use during the study period; If the patient is screened before the visit has been started These moisturizers can then be used in steady doses;
- For women of childbearing age, it should not be during pregnancy or lactation; And all the subjects and their partners were in treatment
Who cannot join
- Other inflammatory diseases that may confuse the diagnosis of AD or interfere with the evaluation of efficacy (e.g. Psoriasis, systemic erythematosus) Sore, scleroderma, mixed connective tissue disease, overlapping syndrome, etc.);
- any of the following laboratory test abnormalities existed before the first drug use (individual indicators during the screening period do not meet, rescreening qualified can still be accepted
- In) :
- Hemoglobin <100 g/L;
- White blood cell count (WBC) <3.5×109/L;
- Neutrophil count <1.5×109/L;
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- Platelet count <100×109/L;
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2× upper limit of normal (ULN);
- Total bilirubin >1.5×ULN;
- Creatinine >1.2×ULN.
- abnormalities in other laboratory tests that, as determined by the investigator, may affect the completion or evaluation of the test;
- Have a history of alcohol or drug abuse, alcoholism or drug dependence within 1 year before screening; Poor compliance as assessed by the investigator (approved Inquire);
- Previous history of allergy to biological products or allergic to BAT6026 or any of its excipients;
- within 6 months before the first drug, did not receive standard treatment (SOC) or SOC failed to infected parasites;
- Systematic administration of antibiotics, antiviral drugs, antiparasitic drugs, antigenics or antigenics is required within 4 weeks before the first medication Antimicrobials are used to treat a variety of systemic infections, and the medical history assessed by the investigator or sponsor may interfere with subjects in this trial Safety, and efficacy evaluators;
- have severe liver, kidney, hematology, gastrointestinal, endocrine, lung, heart, central nervous system or sperm God disease;
- Patients with unstable or uncontrollable hypertension/diabetes need to be excluded, such as those who can be controlled and stabilized by drug treatment The researcher judged that it could continue to be included;
- Superficial skin infection exists within 2 weeks before the first medication;
- Received live vaccine within 4 weeks before the first dose, except inactivated vaccine;
- Participated in any clinical trials 4 weeks before the first medication;
- Received systemic glucocorticoids and other immunizations within 4 weeks or 5 half-lives (whichever is older) prior to the first dose Epidemic inhibitor therapy (e.g., cyclosporine, mycophenolate, interferon gamma, azathioprine, methotrexate, JAK enzyme suppression) Preparations), biological agents;
- Receive any of the following topical drugs for AD within 1 week before the first dose:
- Glucocorticoids (TCS); Calcineurin inhibitors or other immunosuppressants; JAK inhibitor; Antipruritic agents such as clomitone; Compound preparations containing corticosteroids or calcineurin inhibitors or other immunosuppressants; Prescription emollients that affect AD; Chinese herbal medicine, proprietary Chinese medicine and ethnic medicine for AD;
- Received natalizumab or other regulatory B or T cells within 12 months prior to the first dose Drug therapy, such as rituximab, alemtuzumab, abacil (abatacept), etc.
- Received whole-body phototherapy (narrow-spectrum ultraviolet B [NB-UVB], ultraviolet B [UVB], Ultraviolet A [UVA], psoralen combined with ultraviolet A [PUVA])
- Patients who had received major surgery within 4 weeks prior to the first dose or planned to undergo major surgery during the study period, or were unable to undergo surgery before randomization Complete recovery during operation;
- patients with a history of malignant tumors (completely cured cervical carcinoma in situ, non-metastatic skin squamous cell carcinoma, skin Other than basal cell carcinoma), or lymphoproliferative diseases;
- Patients who have received organ transplantation within 3 months before screening (corneal transplantation >3 months before the first administration of the experimental drug) External);
- Pregnant or lactating women, or women who wish to become pregnant;
- there are infected with the following diseases: active hepatitis B virus infection [Hepatitis B surface antigen (HBsAg) positive, and B Hepatovirus deoxyribonucleic acid (HBV-DNA) test >200 IU/ml or 103 copies /ml; Infected with hepatitis C virus [Positive results of HCV antibody and viral ribonucleic acid (HCV-RNA) detection]; Treponema pallidum antibody positive and RPR Positive or other confirmed tests;
- Active tuberculosis includes, but is not limited to, tuberculosis (TB) in patients who have been treated with standardized anti-TB therapy and have been confirmed cured by researchers Included) and patients with latent tuberculosis (positive for Tspot or Quantiferon); History of immunodeficiency, including human immunity A history of HIV infection or other immunodeficiency diseases;
- Those who have participated in OX40 antibody research and used OX40 antibody before;
- Other conditions deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Evaluated the Safety and Efficacy of BAT6026 in Patients With Moderate to Severe Atopic Dermatitis Phase I/II Clinical Study
This is a Phase IB/IIA clinical study of BAT6026 in patients with AD. The subjects were adults with moderate to severe atopic dermatitis (AD) whose disease was not adequately controlled by prior topical medications or for which topical medications were not appropriate. The first phase was the phase IB study, which was double-blind controlled by placebo in the group and consisted of 3 dose groups. After completing the dose escalation study, the phase IIA study was entered. The Phase IIA study was a randomized, double-blind, controlled, multicentering clinical trial with different dose groups and placebo groups. The primary endpoint was to explore the efficacy and safety of BAT6026 in patients with eczema area and severity index (EASI) of at least 75% lower than the baseline at week 16 after 4 treatment cycles. To provide the optimal dose for the phase III regimen.
- Conditions
- Dermatitis, Atopic
- Being tested
- Monoclonal antibody BAT6026, sodium chloride injection
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monoclonal antibody BAT6026Drug
Also called BAT6026
300mg Q4W group, 600mg Q4W group (at week 0,4,8,12) and 600mg Q2W group (at week 0,2,4,6,8,10,12,14)
sodium chloride injectionDrug
300mg Q4W group, 600mg Q4W group (at week 0,4,8,12) and 600mg Q2W group (at week 0,2,4,6,8,10,12,14)
| Study group | Role | What they receive |
|---|---|---|
| A1 300mg | Experimental | Trial drug: Placebo 9:3 randomized double-blind admission. The last patient in each group was given the drug for 1 week, and the existing safety data was reviewed blind by SMC, and the next group was entered into the study after reaching the increasing standard Receives: Drug: Monoclonal antibody BAT6026; Drug: sodium chloride injection |
| B1 600mg | Experimental | Trial drug: Placebo 9:3 randomized double-blind admission. The last patient in each group was given the drug for 1 week, and the existing safety data was reviewed blind by SMC, and the next group was entered into the study after reaching the increasing standard Receives: Drug: Monoclonal antibody BAT6026; Drug: sodium chloride injection |
| C1 600mg | Experimental | Trial drug: Placebo 9:3 randomized double-blind admission. The last patient in each group was given the drug for 1 week, and the existing safety data was reviewed blind by SMC, and the next group was entered into the study after reaching the increasing standard Receives: Drug: Monoclonal antibody BAT6026; Drug: sodium chloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
tolerance
Incidence of AE above 3 Arms associated with the test drug in each dose group
Measured: The last patient in each group was dosed 1 week later
Vital signs
Number of participants with abnormal vital signs
Measured: The last patient in each group was dosed 1 week later
ECG parameters
Number of participants with abnormal ECG readings
Measured: The last patient in each group was dosed 1 week later
Laboratory tests
Number of participants with abnormal laboratory test results
Measured: The last patient in each group was dosed 1 week later
AEs, adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: The last patient in each group was dosed 1 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start9 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase IB/IIA clinical study of BAT6026 in patients with AD. The subjects were adults with moderate to severe atopic dermatitis (AD) whose disease was not adequately controlled by prior topical medications or for which topical medications were not appropriate. The first phase was the phase IB study, which was double-blind controlled by placebo in the group and consisted of 3 dose groups. After completing the dose escalation study, the phase IIA study was entered. The Phase IIA study was a randomized, double-blind, controlled, multicentering clinical trial with different dose groups and placebo groups. The primary endpoint was to explore the efficacy and safety of BAT6026 in patients with eczema area and severity index (EASI) of at least 75% lower than the baseline at week 16 after 4 treatment cycles. To provide the optimal dose for the phase III regimen.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094179
- Sponsor's protocol ID
- BAT-6026-003-CR
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluated the Safety and Efficacy of BAT6026 in Patients With Moderate to Severe Atopic Dermatitis Phase I/II Clinical Study
- ClinicalTrials.gov ID
- NCT06094179
- Acronym / sponsor ID
- BAT-6026-003-CR
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase IB/IIA clinical study of BAT6026 in patients with AD. The subjects were adults with moderate to severe atopic dermatitis (AD) whose disease was not adequately controlled by prior topical medications or for which topical medications were not appropriate. The first phase was the phase IB study, which was double-blind controlled by placebo in the group and consisted of 3 dose groups. After completing the dose escalation study, the phase IIA study was entered. The Phase IIA study was a randomized, double-blind, controlled, multicentering clinical trial with different dose groups and placebo groups. The primary endpoint was to explore the efficacy and safety of BAT6026 in patients with eczema area and severity index (EASI) of at least 75% lower than the baseline at week 16 after 4 treatment cycles. To provide the optimal dose for the phase III regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This is a Phase IB/IIA clinical study of BAT6026 in patients with AD. The subjects were adults with moderate to severe atopic dermatitis (AD) whose disease was not adequately controlled by prior topical medications or for which topical medications were not appropriate. The first phase was the phase IB study, which was double-blind controlled by placebo in the group and consisted of 3 dose groups. After completing the dose escalation study, the phase IIA study was entered. The Phase IIA study was a randomized, double-blind, controlled, multicentering clinical trial with different dose groups and placebo groups. The primary endpoint was to explore the efficacy and safety of BAT6026 in patients with eczema area and severity index (EASI) of at least 75% lower than the baseline at week 16 after 4 treatment cycles. To provide the optimal dose for the phase III regimen.
| Arm | Type | Receives |
|---|---|---|
| A1 300mg | Experimental | Drug: Monoclonal antibody BAT6026, Drug: sodium chloride injectionTrial drug: Placebo 9:3 randomized double-blind admission. The last patient in each group was given the drug for 1 week, and the existing safety data was reviewed blind by SMC, and the next group was entered into the study after reaching the increasing standard |
| B1 600mg | Experimental | Drug: Monoclonal antibody BAT6026, Drug: sodium chloride injectionTrial drug: Placebo 9:3 randomized double-blind admission. The last patient in each group was given the drug for 1 week, and the existing safety data was reviewed blind by SMC, and the next group was entered into the study after reaching the increasing standard |
| C1 600mg | Experimental | Drug: Monoclonal antibody BAT6026, Drug: sodium chloride injectionTrial drug: Placebo 9:3 randomized double-blind admission. The last patient in each group was given the drug for 1 week, and the existing safety data was reviewed blind by SMC, and the next group was entered into the study after reaching the increasing standard |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily sign written informed consent and comply with the requirements of the research protocol;
- age 18-75 years old, male and female;
- According to the Hanifin-Rajka criteria, the patient was diagnosed with AD and had a history of at least 1 year;
- EASI score ≥16 during screening visit and baseline visit;
- IGA score ≥3 at screening and baseline (moderate);
Key exclusion criteria (33 listed)
- Other inflammatory diseases that may confuse the diagnosis of AD or interfere with the evaluation of efficacy (e.g. Psoriasis, systemic erythematosus) Sore, scleroderma, mixed connective tissue disease, overlapping syndrome, etc.);
- any of the following laboratory test abnormalities existed before the first drug use (individual indicators during the screening period do not meet, rescreening qualified can still be accepted
- Have a history of alcohol or drug abuse, alcoholism or drug dependence within 1 year before screening; Poor compliance as assessed by the investigator (approved Inquire);
- Previous history of allergy to biological products or allergic to BAT6026 or any of its excipients;
- within 6 months before the first drug, did not receive standard treatment (SOC) or SOC failed to infected parasites;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monoclonal antibody BAT6026Also: BAT6026300mg Q4W group, 600mg Q4W group (at week 0,4,8,12) and 600mg Q2W group (at week 0,2,4,6,8,10,12,14) | Drug | A1 300mg, B1 600mg, C1 600mg |
| sodium chloride injection300mg Q4W group, 600mg Q4W group (at week 0,4,8,12) and 600mg Q2W group (at week 0,2,4,6,8,10,12,14) | Drug | A1 300mg, B1 600mg, C1 600mg |
Primary outcome
tolerance
Time frame: The last patient in each group was dosed 1 week later
Incidence of AE above 3 Arms associated with the test drug in each dose group
Vital signs
Time frame: The last patient in each group was dosed 1 week later
Number of participants with abnormal vital signs
ECG parameters
Time frame: The last patient in each group was dosed 1 week later
Number of participants with abnormal ECG readings
Laboratory tests
Time frame: The last patient in each group was dosed 1 week later
Number of participants with abnormal laboratory test results
AEs, adverse events
Time frame: The last patient in each group was dosed 1 week later
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Monoclonal antibody BAT6026 and sodium chloride injection in people with Dermatitis, Atopic, run by Bio-Thera Solutions at 1 site in China.
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 9 inclusion and 33 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
tolerance (time frame: The last patient in each group was dosed 1 week later). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.