Evaluate the Safety, Tolerability of BAT6026

NCT06094179 | Active Not Recruiting Phase 1

• 1 other identifier: BAT-6026-003-CR
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (5)

• tolerance

  Incidence of AE above 3 Arms associated with the test drug in each dose group

  The last patient in each group was dosed 1 week later

• Vital signs

  Number of participants with abnormal vital signs

  The last patient in each group was dosed 1 week later

• ECG parameters

  Number of participants with abnormal ECG readings

  The last patient in each group was dosed 1 week later

• Laboratory tests

  Number of participants with abnormal laboratory test results

  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

  The last patient in each group was dosed 1 week later

Study Arms (3)

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

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

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

Drug: Monoclonal antibody BAT6026; Drug: sodium chloride injection

Interventions

Monoclonal antibody BAT6026 DRUG

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)

Also known as: BAT6026

A1 300mg; B1 600mg; C1 600mg

sodium chloride injection DRUG

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)

A1 300mg; B1 600mg; C1 600mg

Eligibility Criteria

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

You may qualify if:

• 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%;
• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

Jianzhong Zhang

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Sodium Chloride

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Phase IB and Phase IIA of this study were double-blind trials. Neither the subject nor the investigator nor the sponsor's project team members were aware of the subject's treatment assignment. Supply of the investigational drug and placebo by the sponsor or designated unit. To reduce the likelihood of subjects being exposed to unnecessary risks while providing the necessary information for dosing escalation, discontinuation and selection, a Safety Management Committee (SMC) will be established to review the subject safety data as necessary.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: October 8, 2023
• First Posted: October 23, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

CN (1)