A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira

NCT04135508 | Completed Phase 3

• 1 other identifier: BAT-1406-003-CR
• Study Type: interventional
• Target: 554
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• Assessment in SpondyloArthritis international Society (ASAS) 20

  the percentage of subjects achieving the Assessment in SpondyloArthritis international Society (ASAS) 20 treatment response

  week 12

Secondary Outcomes (16)

• Percentage of subjects achieving ASAS20 treatment response

  week 24

• Percentage of subjects achieving ASAS40 treatment response

  week 12; week 24

• Percentage of subjects achieving ASAS5/6 treatment response

  week 12; week 24

• Percentage of subjects achieving BASDAI50 treatment response

  week 12; week 24

• Change of the performance status score compared with baseline

  week 12; week 24

Study Arms (2)

BAT1406

EXPERIMENTAL

Adalimumab, 40 mg/0.8 mL/vial, subcutaneously 1 vial every two weeks, up to a maximum of 6 months treatment.

Drug: BAT1406

Humira

ACTIVE COMPARATOR

Adalimumab, 40 mg/0.8 mL/vial, subcutaneously 1 vial every two weeks, up to a maximum of 6 months treatment.

Drug: Humira

Interventions

BAT1406 DRUG

40mg/0.8ml

Also known as: No Other Intervention Names

BAT1406

Humira DRUG

40mg/0.8ml

Also known as: Adalimumab

Humira

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subjects have used any biological products to treat AS within 6 months prior to the enrollment.
• 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).
• Allergic to any ingredients of Humira, allergic to human proteins or susceptible to immunoglobulin allergies.
• 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.
• 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).
• 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.
• Active infections, including acute and chronic infections, and local infections (such as sepsis, abscesses, opportunistic infections, and invasive fungal infections).
• 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).
• Subjects with a history of recurrent herpes zoster, history of Listeria infection, reticuloendotheliosis, and other chronic or recurrent infections.
• 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.
• Subjects with clinically significant laboratory abnormalities that suggested the presence of unknown disease and required further clinical examination.
• Subjects with an apparent history of drug abuse or alcohol dependence at present or in the past 2 years.
• Subjects with one or more of the following diseases:
• Subjects without self-care ability, those who require wheelchairs or those who are bedridden;
• Uncontrolled hypertension (defined as systolic pressure \>150 mmHg, or diastolic pressure \>100 mmHg during the screening period);

Sponsors & Collaborators

• Bio-Thera Solutions: lead

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jieruo Gu, Doctor

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 22, 2019
• Study Start: December 13, 2016
• Primary Completion: March 22, 2018
• Study Completion: May 31, 2018
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share