A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira
A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira
A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira
This is a multicenter, randomized, double-blind, active comparator, parallel two arm study to
 compare the efficacy, and to evaluate the safety, and immunogenicity of BAT1406 to Humira® in
 patients with active ankylosing spondylitis (AS) to demonstrate clinical equivalence of
 BAT1406 and Humira®.
Inclale or female. usion Criteria: 1.Must be between 16-65 years old (inclusive) at the
 time of signing the ICF; 2.Subjects must meet the diagnostic criteria for AS (AS New York
 standard revised in 1984) by providing pelvic X-rays taken within six months prior to
 enrollment.

 3.Subjects suffer from active AS during screening. Active AS is defined as: Bath Ankylosing
 Spondylitis Disease Activity Index (BASDAI) ≥ 4, spinal pain ≥ 4.

 4.Subjects' liver and kidney function indicators should meet the following requirements
 during screening:

 a. Serum creatinine (Cr) < 1.7 × upper limit of normal (ULN), or creatinine clearance (CCr)
 > 75 mL/min.

 b.Alanine Transaminase (ALT) < 2 × ULN. c.Aspartate Transaminase (AST) < 2 × ULN. 5.The
 subjects' hematology laboratory test indicators meet the following requirements during
 screening:

 1. Hemoglobin ≥ 8.0 g/dL.

 2. White blood cell count ≥ 3.5 × 109/L.

 3. Neutrophil count ≥ 1.5×109/L.

 4. Platelet count ≥ 100×109/L. 6.Prior to screening, subjects were allowed to use stable
 doses of MTX (≤ 25 mg/week), sulfasalazine (< 3 g/day), NSAIDs, and/or analgesics, but
 the doses should have been stabled for at least 4 weeks prior to screening, and must
 remain unchanged during the trial.

 7.Prior to screening, subjects were allowed to use glucocorticoids, but are limited to
 daily oral doses of prednisone of ≤ 10 mg or equivalent. Doses should have been stable
 for at least 4 weeks prior to screening, and should remain unchanged during the trial.
 In addition, subjects were permitted to use topical/ophthalmic/otic medications
 containing low potency glucocorticoids according to product monographs.

 8.Subjects discontinuing leflunomide should have been treated with cholestyramine (8
 grams each time, t.i.d) for 11 days, and there should have been a 4-week washout
 period from the first dose of cholestyramine. For subjects discontinuing leflunomide
 and not treated with cholestyramine, a 12-week washout period from the last dose of
 leflunomide to the screening period was required.

 9.During screening, if the subjects were using botanical preparations (such as
 Tripterygium Wilfordii, total glucosides of paeony, sinomenine, yishen juanbi pill,
 etc.) for the treatment of AS, or thalidomide, or were treated with physical therapy,
 they should have stopped these medications and treatments for at least 4 weeks before
 being considered eligible candidates.

 10.During screening, if the subjects had previously received live (attenuated)
 virus/bacterial vaccines, or had received intravenous injection of immunoglobulin IgG,
 they must have stopped the medications for at least 12 weeks before being considered
 eligible for enrollment.

 11.Women of childbearing age must have had a negative serum and/or urine pregnancy
 test prior to enrollment, and must not have been breastfeeding.

 12.Subjects of childbearing age (regardless of gender) must have voluntarily agreed to
 use reliable contraceptive methods (except for non-fertile women and men who have
 undergone vasectomy) from signing of the ICF to 6 months after the last dose of
 treatment. Contraceptive methods include but are not limited to: hormonal
 contraception, physical contraception, or abstinence.

 Note: During screening, women who have entered menopause for less than 12 continuous months
 or men who have undergone vasectomy within 6 months should use reliable contraception
 methods.

 13.Subjects should have the ability to understand the nature and purpose of the trial,
 including possible risks and side effects, be able to understand the verbal and written
 instructions given by the investigators, and can follow the requirements of the trial.

 14.Subjects voluntarily sign the ICF.

 Exclusion Criteria:

 1. Subjects have used any biological products to treat AS within 6 months prior to the
 enrollment.

 2. Clinical or imaging studies suggested that the spine has reached complete rigidity (if
 there were two consecutive lumbar vertebrae not fused together, then the spine has not
 reached complete rigidity).

 3. Allergic to any ingredients of Humira, allergic to human proteins or susceptible to
 immunoglobulin allergies.

 4. Subjects with a medical history of hepatitis B, hepatitis C, HIV, any
 immunodeficiency, or with a positive laboratory test result (hepatitis B surface
 antigen, hepatitis C antibody, or HIV antibody) during screening.

 5. Subjects diagnosed with active pulmonary tuberculosis, latent tuberculosis infection,
 or subjects suspected of tuberculosis based on clinical manifestations (including but
 not limited to pulmonary tuberculosis).

 6. Subjects with positive T.SPOT.TB test or abnormalities in tuberculosis-related chest
 X-ray; or subjects with TB who have not received standard treatment of at least 30
 days.

 7. Active infections, including acute and chronic infections, and local infections (such
 as sepsis, abscesses, opportunistic infections, and invasive fungal infections).

 8. Subjects who have taken oral antibiotics within 2 weeks prior to the screening or have
 been given intramuscular/intravenous treatments for infection within 4 weeks prior to
 the screening, or have had severe infections within 6 months prior to the screening
 (investigators must determine the potential risks of subjects' enrollment based on the
 individual's clinical history).

 9. Subjects with a history of recurrent herpes zoster, history of Listeria infection,
 reticuloendotheliosis, and other chronic or recurrent infections.

 10. Subjects who have undergone ostectomy/arthrectomy/synovectomy within 3 months prior to
 the screening, or planned to undergo joint or spinal surgery during the trial.

 11. Subjects with clinically significant laboratory abnormalities that suggested the
 presence of unknown disease and required further clinical examination.

 12. Subjects with an apparent history of drug abuse or alcohol dependence at present or in
 the past 2 years.

 13. Subjects with one or more of the following diseases:

 1. Subjects without self-care ability, those who require wheelchairs or those who
 are bedridden;

 2. Uncontrolled hypertension (defined as systolic pressure >150 mmHg, or diastolic
 pressure >100 mmHg during the screening period);

 3. Subjects with a history of congestive heart failure (New York Heart Association
 classification III/IV);

 4. Subjects with a history of acute myocardial infarction or unstable angina within
 12 months prior to the screening;

 5. Subjects with serious arrhythmias;

 6. Any subject with clinically significant respiratory diseases, including but not
 limited to chronic obstructive pulmonary disease, asthma, interstitial lung
 disease, bronchiectasis, and pleural effusion;

 7. Subjects with a history of demyelinating diseases or with symptoms suggestive of
 such diseases, including but not limited to: multiple sclerosis and
 Guillain-Barré syndrome;

 8. Subjects who had not used a stable dose of medication to control diabetes within
 4 weeks prior to the screening (glycated hemoglobin HbA1c >7% during screening);

 h.Subjects with any arthritis or rheumatic diseases (in addition to AS) that may
 affect the evaluation of the clinical study, including but not limited to: rheumatoid
 arthritis, osteoarthritis, psoriatic arthritis, systemic lupus erythematosus, gouty
 arthritis, and fibromyalgia; j.Subjects with any neurological, psychotic, or other
 systemic diseases that may affect the clinical efficacy evaluation; k.Subjects who
 have had a history of malignancy in the past 5 years (except for non-metastatic
 squamous cell carcinoma or basal cell carcinoma or cervical carcinoma in situ that
 have been cured); l.History of lymphoma or lymphoproliferative diseases.

 14. Subjects using the following concomitant drugs:

 1. Have used alkylating preparations within 12 months prior to the screening.

 2. Injected corticosteroids into the joint cavity, muscle or vein within 4 weeks
 prior to screening.

 15. Subjects who have participated in other clinical trials within 3 months prior to the
 enrollment or planned to participate in other clinical trials.

 16. The investigator determined that the subject was not suitable for this trial.