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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02893254
Date of registration:	29/08/2016
Prospective Registration:	Yes
Primary sponsor:	Innovent Biologics (Suzhou) Co. Ltd.
Public title:	Efficacy and Safety of IBI303 in Adult Patients With Active Ankylosing Spondylitis
Scientific 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-a (IBI303) Compared to Adalimumab in Patients With Active Ankylosing Spondylitis
Date of first enrolment:	September 22, 2016
Target sample size:	438
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02893254
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
Phase:	Phase 3

Countries of recruitment

Contacts

Name:	Huji Xu
Address:
Telephone:
Email:
Affiliation:	Shanghai Changzheng Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Between 18 and 65 years of age

2. 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)

3. No response, or inadequate response, or intolerant to=1 NSAID at least 4 weeks

4. 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;

5. 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;

6. Glucocorticoid must be withdrawn for at least 4 weeks prior to Baseline, and were not
allowed during the study period.

7. Total duration of prior physical therapy should be at least 2 weeks

8. Traditional Chinese medicines to AS must be withdrawn for at least 28 days prior to
Baseline, and were not allowed during the study period.

9. 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

10. Male subjects' partner, or female subjects should be willing to use adequate
contraception from admission to clinical research center until 5 months post dosing;

11. 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

12. 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

Exclusion Criteria:

1. No response to prior tumor necrosis factor-a inhibitors treatment

2. Use of DMARD(except for sulfasalazine or methotrexate) within 4 weeks prior to
Baseline

3. Use of opioid analgesics(such as methadone, morphine) within 4 weeks prior to Baseline

4. X-ray suggests total spinal ankylosis, or sacroiliac joint fusion

5. Patients with moderate to severe congestive heart failure(NYHA )

6. Has received intra-articular joint injection(s), spinal or paraspinal injection(s)
with corticosteroids within 28 days prior to Baseline

7. Has undergone spinal surgery or joint surgery within 2 months prior to the
administration of the study drugs

8. Patients with other rheumatic diseases or immunodeficiency, including inflammatory
bowel disease(IBD), psoriasis, active uveitis

9. Recent active or chronic infection requiring anti-infective therapy, such as
M.tuberculosis, Listeriosis, Histophasmosis

10. Tuberculosis(TB) history, or a positive T-SPOT test, or chest radiograph suggests
active TB

11. Positive serology for human immunodeficiency virus(HIV) antibody

12. Positive serology for hepatitis C virus antibody

13. Active or chronic HBV infection, such as positive hepatitis B virus surface antigen

14. 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)

15. History of relevant allergy/hypersensitivity (including allergy to the study
medications or its excipients)

16. Prior or recent central nervous system demyelinating disease or multiple sclerosis

17. Use of live vaccines within 3 months prior to Baseline

18. Pregnant or breastfeeding women

19. Suspected or confirmed drug/alcohol use

20. Participation in another interventional trial within 3 months prior to administration

21. Subjects with serious psychiatric or nervous system diseases, or patients who have
difficulty in informing consent or AE presentation, or illiterate patients

22. 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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Intervention(s)

Drug: Adalimumab

Drug: IBI303

Primary Outcome(s)

Number of participants meeting the Assessment of Spondyloarthritis International Society(ASAS) ASAS20 Response Criteria [Time Frame: Week 24]

Secondary Outcome(s)

Number of participants meeting the ASAS20 Response [Time Frame: 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 12]

Number of Participants Meeting the ASAS Partial Remission [Time Frame: Week 24]

Number of participants meeting the ASAS20 Response [Time Frame: Week 12]

Change from Baseline in Patient Global Assessment of Disease Activity [Time Frame: Baseline and Week 12]

Number of Participants Meeting the ASAS Partial Remission [Time Frame: Week 12]

Number of Participants Meeting the ASAS Partial Remission [Time Frame: Week 20]

Number of Participants Meeting the ASAS Partial Remission [Time Frame: Week 4]

Number of Participants Meeting the ASAS5/6 Response Criteria [Time Frame: Week 20]

Number of Participants Meeting the ASAS5/6 Response Criteria [Time Frame: Week 4]

Change from Baseline in EQ-5D/WPAI-SHP/HAQ-S QoL [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]

Change from Baseline in Total Back Pain Score [Time Frame: Baseline and Week 24]

Change from Baseline in EQ-5D/WPAI-SHP/HAQ-S QoL [Time Frame: Baseline and Week 12]

Change from Baseline in Patient Global Assessment of Disease Activity [Time Frame: Baseline and Week 24]

Number of participants meeting the ASAS20 Response [Time Frame: Week 16]

Number of participants meeting the ASAS20 Response [Time Frame: Week 8]

Change from Baseline in ASDAS-CRP and ASDAS-ESR [Time Frame: Baseline and Week 12]

Number of participants meeting the ASAS40 Response Criteria [Time Frame: Week 24]

Number of participants meeting the ASAS40 Response Criteria [Time Frame: Week16]

Change from Baseline in Maastricht Ankylosing Spondylitis Enthesis Score(MASES) [Time Frame: Baseline and Week 12]

Change from Baseline in Maastricht Ankylosing Spondylitis Enthesis Score(MASES) [Time Frame: Baseline and Week 24]

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 24]

Number of participants meeting the ASAS20 Response [Time Frame: Week 20]

Number of Participants Meeting the ASAS5/6 Response Criteria [Time Frame: Week 2]

Change from Baseline in Total Back Pain Score [Time Frame: Baseline and Week 12]

Number of Participants Meeting the ASAS Partial Remission [Time Frame: Week 16]

Number of participants meeting the ASAS20 Response [Time Frame: Week 4]

Number of participants meeting the ASAS40 Response Criteria [Time Frame: Week 4]

Number of participants meeting the ASAS40 Response Criteria [Time Frame: Week12]

Number of participants meeting the ASAS40 Response Criteria [Time Frame: Week20]

Number of Participants Meeting the ASAS5/6 Response Criteria [Time Frame: Week 8]

Change from Baseline in ASDAS-CRP and ASDAS-ESR [Time Frame: Baseline and 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 ASAS Partial Remission [Time Frame: Week 2]

Number of Participants Meeting the ASAS Partial Remission [Time Frame: Week 8]

Number of participants meeting the ASAS40 Response Criteria [Time Frame: Week 2]

Number of participants meeting the ASAS40 Response Criteria [Time Frame: Week 8]

Number of Participants Meeting the ASAS5/6 Response Criteria [Time Frame: Week 16]

Secondary ID(s)

CIBI303A301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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