ASPhase 3NCT02893254
Efficacy and Safety of IBI303 in Adult Patients With Active Ankylosing Spondylitis
A Phase 3 study testing IBI303 and Adalimumab in people with AS, run by Innovent Biologics (Suzhou) Co. Ltd..
Trial summary
Study of the efficacy and safety of IBI303 compared with adalimumab in adult patients with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AS
- What is being tested?
- IBI303 and Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2016to 16 Mar 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 65 years of age
- Fulfilled modified New York Criteria for AS, had active disease（as defined by≥2 of the following: Bath AS Disease Activity Index(BASDAI) ≥4(10cm VAS); total back pain≥40(100mm VAS) and ≥1 hour of morning stiffness）
- No response, or inadequate response, or intolerant to≥1 NSAID at least 4 weeks
- Participants who are regularly taking DMARDs(SSZ≤3g/day，MTX≤15mg/week) as part of their AS therapy are required to be on a stable dose ≥28 days prior to Baseline, and are required to be on a stable DMARDs dose and to accept oral folic acid therapy(≥5mg/week) during the study period；
- Participants who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose ≥14 days prior to Baseline, and are required to be on a stable dose during the study period；
- Glucocorticoid must be withdrawn for at least 4 weeks prior to Baseline, and were not allowed during the study period.
Show all 12Show fewer
- Total duration of prior physical therapy should be at least 2 weeks
- Traditional Chinese medicines to AS must be withdrawn for at least 28 days prior to Baseline, and were not allowed during the study period.
- Biological agents must be withdrawn: etanercept and anakinra(IL-1 receptor antagonist) for at least 4 weeks prior to administration; tocilizumab(IL-6 monoclonal antibody) for at least 12 weeks prior to administration; other biological agents for 12 weeks or 5 half-lives(whichever is longer) prior to administration
- Male subjects' partner, or female subjects should be willing to use adequate contraception from admission to clinical research center until 5 months post dosing；
- To fully understanding the purpose of the study, to understand the pharmacological action of the study drugs and the possible adverse reactions; participants who are voluntary to sign the informed consent according to the Declaration of Helsinki
- Blood routine examination: hemoglobin ≥90g/L, WBC count ≥3.5×109/L, PLT count ≥100×109/L; liver function examination: total bilirubin(TBIL), direct bilirubin(DBIL), aspartate transaminase(AST) or alanine aminotransferase (ALT) <1.5×ULN; kidney function examination：creatinine(Cr) ≤ULM, usea nitrogen(BUN) ≤1.25×ULN
Who cannot join
- No response to prior tumor necrosis factor-α inhibitors treatment
- Use of DMARD(except for sulfasalazine or methotrexate) within 4 weeks prior to Baseline
- Use of opioid analgesics(such as methadone, morphine) within 4 weeks prior to Baseline
- X-ray suggests total spinal ankylosis, or sacroiliac joint fusion
- Patients with moderate to severe congestive heart failure（NYHA ）
- Has received intra-articular joint injection(s), spinal or paraspinal injection(s) with corticosteroids within 28 days prior to Baseline
Show all 22Show fewer
- Has undergone spinal surgery or joint surgery within 2 months prior to the administration of the study drugs
- Patients with other rheumatic diseases or immunodeficiency, including inflammatory bowel disease(IBD), psoriasis, active uveitis
- Recent active or chronic infection requiring anti-infective therapy, such as M.tuberculosis, Listeriosis, Histophasmosis
- Tuberculosis(TB) history, or a positive T-SPOT test, or chest radiograph suggests active TB
- Positive serology for human immunodeficiency virus(HIV) antibody
- Positive serology for hepatitis C virus antibody
- Active or chronic HBV infection, such as positive hepatitis B virus surface antigen
- Malignancy history ≤5 years（except for successfully treated cutaneous squamous cell carcinoma, or basal cell carcinoma, or localized cervical carcinoma in situ, or breast ductal carcinoma in situ）
- History of relevant allergy/hypersensitivity (including allergy to the study medications or its excipients)
- Prior or recent central nervous system demyelinating disease or multiple sclerosis
- Use of live vaccines within 3 months prior to Baseline
- Pregnant or breastfeeding women
- Suspected or confirmed drug/alcohol use
- Participation in another interventional trial within 3 months prior to administration
- Subjects with serious psychiatric or nervous system diseases, or patients who have difficulty in informing consent or AE presentation, or illiterate patients
- Subjects who are unable to complete the study, or who may not be able to comply with the requirement of the study, judged by the investigators
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Monoclonal Antibody Against Human Tumor Necrosis Factor-α (IBI303) Compared to Adalimumab in Patients With Active Ankylosing Spondylitis
Study of the efficacy and safety of IBI303 compared with adalimumab in adult patients with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)
Read the detailed description
Adults patients with active ankylosing spondylitis (AS) were randomized in a 1:1 ratio to receive treatment with adalimumab 40 mg every other week (eow) or IBI303, given subcutaneously (SC), in the 24-week double-blind (DB) phase. Randomized participants received one SC injection of the appropriate DB study medication (adalimumab 40 mg or IBI303) at Week 0 and then eow until Week 22. A follow-up visit occurred 70 days(Week 32) after the last dose of study drug to obtain information on any ongoing or new adverse events (AEs).
- Conditions
- AS
- Being tested
- IBI303, Adalimumab
- Keywords
- ankylosing spondylitis, tumor necrosis factor-α inhibitors
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI303Drug
12 cycles. IBI303: 40 mg, iH
AdalimumabDrug
12 cycles. Adalimumab: 40mg, iH
| Study group | Role | What they receive |
|---|---|---|
| IBI303 | Experimental | IBI303 40mg administered subcutaneously every other week, 12cycles Receives: Drug: IBI303 |
| Adalimumab | Active comparator | Adalimumab 40mg administered subcutaneously every other week Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants meeting the Assessment of Spondyloarthritis International Society(ASAS) ASAS20 Response Criteria
Measured: Week 24
Secondary outcomes (46)
Number of participants meeting the ASAS20 Response
Measured: Week 2
Number of participants meeting the ASAS20 Response
Measured: Week 4
Number of participants meeting the ASAS20 Response
Measured: Week 8
Number of participants meeting the ASAS20 Response
Measured: Week 12
Number of participants meeting the ASAS20 Response
Measured: Week 16
Number of participants meeting the ASAS20 Response
Measured: Week 20
Number of participants meeting the ASAS40 Response Criteria
Measured: Week 24
Number of Participants Meeting the ASAS5/6 Response Criteria
Measured: Week 24
Number of Participants Meeting the ASAS Partial Remission
Measured: Week 24
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Measure Index(BASMI)
Measured: Baseline and Week 24
Number of participants meeting the ASAS40 Response Criteria
Measured: Week 2
Number of participants meeting the ASAS40 Response Criteria
Measured: Week 4
Number of participants meeting the ASAS40 Response Criteria
Measured: Week 8
Number of participants meeting the ASAS40 Response Criteria
Measured: Week12
Number of participants meeting the ASAS40 Response Criteria
Measured: Week16
Number of participants meeting the ASAS40 Response Criteria
Measured: Week20
Number of Participants Meeting the ASAS5/6 Response Criteria
Measured: Week 2
Number of Participants Meeting the ASAS5/6 Response Criteria
Measured: Week 4
Number of Participants Meeting the ASAS5/6 Response Criteria
Measured: Week 8
Number of Participants Meeting the ASAS5/6 Response Criteria
Measured: Week 12
Number of Participants Meeting the ASAS5/6 Response Criteria
Measured: Week 16
Number of Participants Meeting the ASAS5/6 Response Criteria
Measured: Week 20
Number of Participants Meeting the ASAS Partial Remission
Measured: Week 2
Number of Participants Meeting the ASAS Partial Remission
Measured: Week 4
Number of Participants Meeting the ASAS Partial Remission
Measured: Week 8
Number of Participants Meeting the ASAS Partial Remission
Measured: Week 12
Number of Participants Meeting the ASAS Partial Remission
Measured: Week 16
Number of Participants Meeting the ASAS Partial Remission
Measured: Week 20
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)
Measured: Baseline and Week 2
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)
Measured: Baseline and Week 4
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)
Measured: Baseline and Week 8
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)
Measured: Baseline and Week 12
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)
Measured: Baseline and Week 16
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)
Measured: Baseline and Week 20
Change from Baseline in Patient Global Assessment of Disease Activity
Measured: Baseline and Week 12
Change from Baseline in Patient Global Assessment of Disease Activity
Measured: Baseline and Week 24
Change from Baseline in Total Back Pain Score
Measured: Baseline and Week 12
Change from Baseline in Total Back Pain Score
Measured: Baseline and Week 24
Change From Baseline in Inflammation Score
Measured: Baseline and Week 12
Change From Baseline in Inflammation Score
Measured: Baseline and Week 24
Change from Baseline in Maastricht Ankylosing Spondylitis Enthesis Score(MASES)
Measured: Baseline and Week 12
Change from Baseline in Maastricht Ankylosing Spondylitis Enthesis Score(MASES)
Measured: Baseline and Week 24
Change from Baseline in ASDAS-CRP and ASDAS-ESR
Measured: Baseline and Week 12
Change from Baseline in ASDAS-CRP and ASDAS-ESR
Measured: Baseline and Week 24
Change from Baseline in EQ-5D/WPAI-SHP/HAQ-S QoL
Measured: Baseline and Week 12
Change from Baseline in EQ-5D/WPAI-SHP/HAQ-S QoL
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start22 Sep 2016
- Primary completion22 Jan 2018
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ASStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huji Xu, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893254
- Sponsor's protocol ID
- CIBI303A301
- Status last verified
- Jun 2018
- First submitted
- 29 Aug 2016
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Huang F, Gu J, Zhu P, Bao C, Xu J, Xu H, Wu H, Wang G, Shi Q, Andhivarothai N, Anderson J, Pangan AL. Efficacy and safety of adalimumab in Chinese adults with active ankylosing spondylitis: results of a randomised, controlled trial. Ann Rheum Dis. 2014 Mar;73(3):587-94. doi: 10.1136/annrheumdis-2012-202533. Epub 2013 Mar 8.
PubMed 23475983Xu H, Li Z, Wu J, Xing Q, Shi G, Li J, Liu X, Wu L, Li X, Tan W, He D, Bi L, Li H, Xiao Z, Shuai Z, Li X, Wang Y, Luo L, Zheng Y, Xiao W, Wu X, Zhou L, Li T, Qian L, Zhou H, Lu S, Zheng S, Xiong Y, Wang X, Wang Y, Wu X. IBI303, a biosimilar to adalimumab, for the treatment of patients with ankylosing spondylitis in China: a randomised, double-blind, phase 3 equivalence trial. Lancet Rheumatol. 2019 Sep;1(1):e35-e43. doi: 10.1016/S2665-9913(19)30013-X. Epub 2019 Aug 28.
PubMed 38229357
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Monoclonal Antibody Against Human Tumor Necrosis Factor-α (IBI303) Compared to Adalimumab in Patients With Active Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT02893254
- Acronym / sponsor ID
- CIBI303A301
- Conditions
- AS
- Keywords
- ankylosing spondylitis, tumor necrosis factor-α inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2016 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
Study of the efficacy and safety of IBI303 compared with adalimumab in adult patients with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)
Detailed description
Adults patients with active ankylosing spondylitis (AS) were randomized in a 1:1 ratio to receive treatment with adalimumab 40 mg every other week (eow) or IBI303, given subcutaneously (SC), in the 24-week double-blind (DB) phase. Randomized participants received one SC injection of the appropriate DB study medication (adalimumab 40 mg or IBI303) at Week 0 and then eow until Week 22. A follow-up visit occurred 70 days(Week 32) after the last dose of study drug to obtain information on any ongoing or new adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI303 | Experimental | Drug: IBI303IBI303 40mg administered subcutaneously every other week, 12cycles |
| Adalimumab | Active comparator | Drug: AdalimumabAdalimumab 40mg administered subcutaneously every other week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Between 18 and 65 years of age
- Fulfilled modified New York Criteria for AS, had active disease（as defined by≥2 of the following: Bath AS Disease Activity Index(BASDAI) ≥4(10cm VAS); total back pain≥40(100mm VAS) and ≥1 hour of morning stiffness）
- No response, or inadequate response, or intolerant to≥1 NSAID at least 4 weeks
- Participants who are regularly taking DMARDs(SSZ≤3g/day，MTX≤15mg/week) as part of their AS therapy are required to be on a stable dose ≥28 days prior to Baseline, and are required to be on a stable DMARDs dose and to accept oral folic acid therapy(≥5mg/week) during the study period；
- Participants who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose ≥14 days prior to Baseline, and are required to be on a stable dose during the study period；
Key exclusion criteria (22 listed)
- No response to prior tumor necrosis factor-α inhibitors treatment
- Use of DMARD(except for sulfasalazine or methotrexate) within 4 weeks prior to Baseline
- Use of opioid analgesics(such as methadone, morphine) within 4 weeks prior to Baseline
- X-ray suggests total spinal ankylosis, or sacroiliac joint fusion
- Patients with moderate to severe congestive heart failure（NYHA ）
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 |
|---|---|---|
| IBI30312 cycles. IBI303: 40 mg, iH | Drug | IBI303 |
| Adalimumab12 cycles. Adalimumab: 40mg, iH | Drug | Adalimumab |
Primary outcome
Number of participants meeting the Assessment of Spondyloarthritis International Society(ASAS) ASAS20 Response Criteria
Time frame: Week 24
46 secondary outcomes
Number of participants meeting the ASAS20 Response
Time frame: Week 2
Number of participants meeting the ASAS20 Response
Time frame: Week 4
Number of participants meeting the ASAS20 Response
Time frame: Week 8
Number of participants meeting the ASAS20 Response
Time frame: Week 12
Number of participants meeting the ASAS20 Response
Time frame: Week 16
Number of participants meeting the ASAS20 Response
Time frame: Week 20
Number of participants meeting the ASAS40 Response Criteria
Time frame: Week 24
Number of Participants Meeting the ASAS5/6 Response Criteria
Time frame: Week 24
Number of Participants Meeting the ASAS Partial Remission
Time frame: Week 24
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Measure Index(BASMI)
Time frame: Baseline and Week 24
Number of participants meeting the ASAS40 Response Criteria
Time frame: Week 2
Number of participants meeting the ASAS40 Response Criteria
Time frame: Week 4
Number of participants meeting the ASAS40 Response Criteria
Time frame: Week 8
Number of participants meeting the ASAS40 Response Criteria
Time frame: Week12
Number of participants meeting the ASAS40 Response Criteria
Time frame: Week16
Number of participants meeting the ASAS40 Response Criteria
Time frame: Week20
Number of Participants Meeting the ASAS5/6 Response Criteria
Time frame: Week 2
Number of Participants Meeting the ASAS5/6 Response Criteria
Time frame: Week 4
Number of Participants Meeting the ASAS5/6 Response Criteria
Time frame: Week 8
Number of Participants Meeting the ASAS5/6 Response Criteria
Time frame: Week 12
Number of Participants Meeting the ASAS5/6 Response Criteria
Time frame: Week 16
Number of Participants Meeting the ASAS5/6 Response Criteria
Time frame: Week 20
Number of Participants Meeting the ASAS Partial Remission
Time frame: Week 2
Number of Participants Meeting the ASAS Partial Remission
Time frame: Week 4
Number of Participants Meeting the ASAS Partial Remission
Time frame: Week 8
Number of Participants Meeting the ASAS Partial Remission
Time frame: Week 12
Number of Participants Meeting the ASAS Partial Remission
Time frame: Week 16
Number of Participants Meeting the ASAS Partial Remission
Time frame: Week 20
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)
Time frame: Baseline and Week 2
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)
Time frame: Baseline and Week 4
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)
Time frame: Baseline and Week 8
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)
Time frame: Baseline and Week 12
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)
Time frame: Baseline and Week 16
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(BASDAI), in Bath Ankylosing Spondylitis Functional Index(BASFI), in Bath Ankylosing Spondylitis Messure Index(BASMI)
Time frame: Baseline and Week 20
Change from Baseline in Patient Global Assessment of Disease Activity
Time frame: Baseline and Week 12
Change from Baseline in Patient Global Assessment of Disease Activity
Time frame: Baseline and Week 24
Change from Baseline in Total Back Pain Score
Time frame: Baseline and Week 12
Change from Baseline in Total Back Pain Score
Time frame: Baseline and Week 24
Change From Baseline in Inflammation Score
Time frame: Baseline and Week 12
Change From Baseline in Inflammation Score
Time frame: Baseline and Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Results publication: PubMed 23475983Huang F, Gu J, Zhu P, Bao C, Xu J, Xu H, Wu H, Wang G, Shi Q, Andhivarothai N, Anderson J, Pangan AL. Efficacy and safety of adalimumab in Chinese adults with active ankylosing spondylitis: results of a randomised, controlled trial. Ann Rheum Dis. 2014 Mar;73(3):587-94. doi: 10.1136/annrheumdis-2012-202533. Epub 2013 Mar 8.
- Derived from this study: PubMed 38229357Xu H, Li Z, Wu J, Xing Q, Shi G, Li J, Liu X, Wu L, Li X, Tan W, He D, Bi L, Li H, Xiao Z, Shuai Z, Li X, Wang Y, Luo L, Zheng Y, Xiao W, Wu X, Zhou L, Li T, Qian L, Zhou H, Lu S, Zheng S, Xiong Y, Wang X, Wang Y, Wu X. IBI303, a biosimilar to adalimumab, for the treatment of patients with ankylosing spondylitis in China: a randomised, double-blind, phase 3 equivalence trial. Lancet Rheumatol. 2019 Sep;1(1):e35-e43. doi: 10.1016/S2665-9913(19)30013-X. Epub 2019 Aug 28.
Related trials for AS
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Huji Xu principal investigator
Shanghai Changzheng Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IBI303 and Adalimumab in people with AS, run by Innovent Biologics (Suzhou) Co. Ltd..
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 12 inclusion and 22 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: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants meeting the Assessment of Spondyloarthritis International Society(ASAS) ASAS20 Response Criteria (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893254, which also lists 2 linked publications.
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 4 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.