Evaluate the Safety, Tolerability of BAT6026

Last updated: November 14, 2024
Sponsor: Bio-Thera Solutions
Overall Status: Active - Recruiting

Phase

1/2

Condition

Rash

Allergy

Eczema (Atopic Dermatitis - Pediatric)

Treatment

sodium chloride injection

Monoclonal antibody BAT6026

Clinical Study ID

NCT06094179
BAT-6026-003-CR
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntarily sign written informed consent and comply with the requirements of theresearch protocol;

  2. age 18-75 years old, male and female;

  3. According to the Hanifin-Rajka criteria, the patient was diagnosed with AD and had ahistory of at least 1 year;

  4. EASI score ≥16 during screening visit and baseline visit;

  5. IGA score ≥3 at screening and baseline (moderate);

  6. BSA involvement at screening and baseline was ≥10%;

  7. Received glucocorticoids, phosphodiesterase inhibitors, or calcineurin inhibition inthe 6 months prior to screening Drug, or phototherapy for AD and other localtreatment options, and according to the judgment of the investigator, the localtreatment response is insufficient (follow the doctor Local treatment is prescribedfor at least 4 weeks or to the maximum recommended course of treatment in theproduct's prescribing information, whichever is shorter, which has not been achievedIs in remission or in a state of low disease activity (IGA 0 to 2), has no responseor intolerance, or has a medical contraindication to the treatment, and is notsuitable for the use of this local treatment;

  8. Steady-dose topical emollients (subjects must use investigator-recommended orinvestigator-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 studyperiod; If the patient is screened before the visit has been started Thesemoisturizers can then be used in steady doses;

  9. For women of childbearing age, it should not be during pregnancy or lactation; Andall the subjects and their partners were in treatment

Exclusion

Exclusion Criteria:

  1. Other inflammatory diseases that may confuse the diagnosis of AD or interfere withthe evaluation of efficacy (e.g. Psoriasis, systemic erythematosus) Sore,scleroderma, mixed connective tissue disease, overlapping syndrome, etc.);

  2. any of the following laboratory test abnormalities existed before the first drug use (individual indicators during the screening period do not meet, rescreeningqualified can still be accepted In) :

  3. Hemoglobin <100 g/L;

  4. White blood cell count (WBC) <3.5×109/L;

  5. Neutrophil count <1.5×109/L;

  6. Platelet count <100×109/L;

  7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2× upperlimit of normal (ULN);

  8. Total bilirubin >1.5×ULN;

  9. Creatinine >1.2×ULN.

  10. abnormalities in other laboratory tests that, as determined by theinvestigator, may affect the completion or evaluation of the test;

  11. Have a history of alcohol or drug abuse, alcoholism or drug dependence within 1 yearbefore screening; Poor compliance as assessed by the investigator (approvedInquire);

  12. Previous history of allergy to biological products or allergic to BAT6026 or any ofits excipients;

  13. within 6 months before the first drug, did not receive standard treatment (SOC) orSOC failed to infected parasites;

  14. Systematic administration of antibiotics, antiviral drugs, antiparasitic drugs,antigenics or antigenics is required within 4 weeks before the first medicationAntimicrobials are used to treat a variety of systemic infections, and the medicalhistory assessed by the investigator or sponsor may interfere with subjects in thistrial Safety, and efficacy evaluators;

  15. have severe liver, kidney, hematology, gastrointestinal, endocrine, lung, heart,central nervous system or sperm God disease;

  16. Patients with unstable or uncontrollable hypertension/diabetes need to be excluded,such as those who can be controlled and stabilized by drug treatment The researcherjudged that it could continue to be included;

  17. Superficial skin infection exists within 2 weeks before the first medication;

  18. Received live vaccine within 4 weeks before the first dose, except inactivatedvaccine;

  19. Participated in any clinical trials 4 weeks before the first medication;

  20. Received systemic glucocorticoids and other immunizations within 4 weeks or 5half-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;

  21. Receive any of the following topical drugs for AD within 1 week before the firstdose: Glucocorticoids (TCS); Calcineurin inhibitors or other immunosuppressants; JAKinhibitor; Antipruritic agents such as clomitone; Compound preparations containingcorticosteroids or calcineurin inhibitors or other immunosuppressants; Prescriptionemollients that affect AD; Chinese herbal medicine, proprietary Chinese medicine andethnic medicine for AD;

  22. Received natalizumab or other regulatory B or T cells within 12 months prior to thefirst dose Drug therapy, such as rituximab, alemtuzumab, abacil (abatacept), etc.

  23. Received whole-body phototherapy (narrow-spectrum ultraviolet B [NB-UVB],ultraviolet B [UVB], Ultraviolet A [UVA], psoralen combined with ultraviolet A [PUVA])

  24. Patients who had received major surgery within 4 weeks prior to the first dose orplanned to undergo major surgery during the study period, or were unable to undergosurgery before randomization Complete recovery during operation;

  25. patients with a history of malignant tumors (completely cured cervical carcinoma insitu, non-metastatic skin squamous cell carcinoma, skin Other than basal cellcarcinoma), or lymphoproliferative diseases;

  26. Patients who have received organ transplantation within 3 months before screening (corneal transplantation >3 months before the first administration of theexperimental drug) External);

  27. Pregnant or lactating women, or women who wish to become pregnant;

  28. there are infected with the following diseases: active hepatitis B virus infection [Hepatitis B surface antigen (HBsAg) positive, and B Hepatovirus deoxyribonucleicacid (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;

  29. Active tuberculosis includes, but is not limited to, tuberculosis (TB) in patientswho have been treated with standardized anti-TB therapy and have been confirmedcured by researchers Included) and patients with latent tuberculosis (positive forTspot or Quantiferon); History of immunodeficiency, including human immunity Ahistory of HIV infection or other immunodeficiency diseases;

  30. Those who have participated in OX40 antibody research and used OX40 antibody before;

  31. Other conditions deemed unsuitable for study participation by the investigator.

Study Design

Total Participants: 33
Treatment Group(s): 2
Primary Treatment: sodium chloride injection
Phase: 1/2
Study Start date:
November 09, 2023
Estimated Completion Date:
October 15, 2025

Connect with a study center

  • Jianzhong Zhang

    Beijing, Beijing
    China

    Active - Recruiting

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