Adults 18 to 50, any sex, with Nonradiographic Axial Spondylitis, Ankylosing. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24Primary· Week 24
ASAS 20 defined as improvement of greater than or equal to (\>=) 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 centimeter(cm) scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;0=none,10=very
Group
Value
95% CI
Placebo
47.6
Ustekinumab 45 mg
55.4
Ustekinumab 90 mg
49.4
Percentage of Participants Who Achieved an ASAS 40 Response at Week 24Secondary· Week 24
ASAS 40 defined as improvement of \>= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor),total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10 cm; 0=none,10=very severe); no worsening at
Group
Value
95% CI
Placebo
25.6
Ustekinumab 45 mg
33.7
Ustekinumab 90 mg
28.2
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24Secondary· Week 24
The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness were added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-
Group
Value
95% CI
Placebo
23.2
Ustekinumab 45 mg
32.5
Ustekinumab 90 mg
25.9
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24Secondary· Baseline, Week 24
The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of ankylosing spondylitis participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicat
Group
Value
95% CI
Placebo
-2.11
± 2.371
Ustekinumab 45 mg
-2.28
± 2.625
Ustekinumab 90 mg
-1.90
± 2.731
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP) Inactive Disease (<1.3) at Week 24Secondary· Week 24
ASDAS includes CRP milligram per liter (mg/L); four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale \[NRS\]) included total back pain(TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121\*total back pain)+ (0.110\*PGA)+ (0.073\*peripheral pain/swelling)+ (0.058\* DMS)+ (0.579\*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being
Group
Value
95% CI
Placebo
7.3
Ustekinumab 45 mg
14.5
Ustekinumab 90 mg
12.9
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24Secondary· Baseline, Week 4, 8, 12, 16, 20 and 24
Change from baseline in hsCRP levels was reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing). Here 'n' signifies the number of participants who were analyzed at each specified timepoints, for each arm, respectively.
Change at Week 4
Group
Value
95% CI
Placebo
-0.08
± 1.567
Ustekinumab 45 mg
-0.10
± 2.574
Ustekinumab 90 mg
-0.39
± 1.601
Change at Week 8
Group
Value
95% CI
Placebo
-0.23
± 1.490
Ustekinumab 45 mg
-0.53
± 2.084
Ustekinumab 90 mg
-0.57
± 2.209
Change at Week 12
Group
Value
95% CI
Placebo
-0.23
± 1.661
Ustekinumab 45 mg
-0.71
± 2.392
Ustekinumab 90 mg
-0.61
± 2.534
Change at Week 16
Group
Value
95% CI
Placebo
-0.49
± 1.725
Ustekinumab 45 mg
-0.63
± 2.211
Ustekinumab 90 mg
-0.61
± 2.539
Change at Week 20
Group
Value
95% CI
Placebo
-0.36
± 1.951
Ustekinumab 45 mg
-0.78
± 2.353
Ustekinumab 90 mg
-0.76
± 2.383
Change at Week 24
Group
Value
95% CI
Placebo
-0.42
± 2.145
Ustekinumab 45 mg
-0.63
± 2.402
Ustekinumab 90 mg
-0.78
± 2.413
Percentage of Participants With ASAS 20 Components at Week 24Secondary· Week 24
ASAS 20 defined as \>= 20% improvement from baseline in 4 individual components of ASAS20: Patient's global assessment (PGA) of disease activity (0 to 10cm; 0=very well,10=very poor), total back pain(0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean(0 to10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to functional anatomy and 2 relate to participant's ability to cope with life) and Inflammation (0 to 10cm;0=none,10=very severe).
>=20% improvement from baseline in PGA score
Group
Value
95% CI
Placebo
64.1
Ustekinumab 45 mg
61.3
Ustekinumab 90 mg
58.8
>=20% improvement from baseline in total back pain
Group
Value
95% CI
Placebo
62.8
Ustekinumab 45 mg
60.0
Ustekinumab 90 mg
60.0
>=20% improvement from baseline in BASFI
Group
Value
95% CI
Placebo
53.8
Ustekinumab 45 mg
57.5
Ustekinumab 90 mg
56.3
>=20% improvement from baseline in inflammation
Group
Value
95% CI
Placebo
64.1
Ustekinumab 45 mg
66.3
Ustekinumab 90 mg
65.0
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20Secondary· Week 4, 8, 12, 16 and 20
ASAS 40 defined as improvement of \>= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all fr
Week 4
Group
Value
95% CI
Placebo
3.7
Ustekinumab 45 mg
8.4
Ustekinumab 90 mg
11.8
Week 8
Group
Value
95% CI
Placebo
18.3
Ustekinumab 45 mg
19.3
Ustekinumab 90 mg
18.8
Week 12
Group
Value
95% CI
Placebo
17.1
Ustekinumab 45 mg
27.7
Ustekinumab 90 mg
24.7
Week 16
Group
Value
95% CI
Placebo
19.5
Ustekinumab 45 mg
27.7
Ustekinumab 90 mg
24.7
Week 20
Group
Value
95% CI
Placebo
24.4
Ustekinumab 45 mg
38.6
Ustekinumab 90 mg
32.9
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20Secondary· Week 4, 8, 12, 16 and 20
ASAS 20 defined as improvement of \>= 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;0=none,10=very severe); absence of deterioration (\>=
Week 4
Group
Value
95% CI
Placebo
23.2
Ustekinumab 45 mg
26.5
Ustekinumab 90 mg
32.9
Week 8
Group
Value
95% CI
Placebo
31.7
Ustekinumab 45 mg
41.0
Ustekinumab 90 mg
36.5
Week 12
Group
Value
95% CI
Placebo
34.1
Ustekinumab 45 mg
48.2
Ustekinumab 90 mg
41.2
Week 16
Group
Value
95% CI
Placebo
40.2
Ustekinumab 45 mg
49.4
Ustekinumab 90 mg
35.3
Week 20
Group
Value
95% CI
Placebo
45.1
Ustekinumab 45 mg
59.0
Ustekinumab 90 mg
44.7
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20Secondary· Week 4, 8, 12, 16, and 20
The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging
Week 4
Group
Value
95% CI
Placebo
4.9
Ustekinumab 45 mg
8.4
Ustekinumab 90 mg
8.2
Week 8
Group
Value
95% CI
Placebo
9.8
Ustekinumab 45 mg
15.7
Ustekinumab 90 mg
17.6
Week 12
Group
Value
95% CI
Placebo
18.3
Ustekinumab 45 mg
16.9
Ustekinumab 90 mg
28.2
Week 16
Group
Value
95% CI
Placebo
19.5
Ustekinumab 45 mg
21.7
Ustekinumab 90 mg
24.7
Week 20
Group
Value
95% CI
Placebo
15.9
Ustekinumab 45 mg
28.9
Ustekinumab 90 mg
32.9
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20Secondary· Baseline, Week 4, 8, 12, 16 and 20
The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe funct
Change at Week 4
Group
Value
95% CI
Placebo
-0.60
± 1.582
Ustekinumab 45 mg
-1.15
± 1.748
Ustekinumab 90 mg
-0.79
± 1.600
Change at Week 8
Group
Value
95% CI
Placebo
-0.82
± 1.997
Ustekinumab 45 mg
-1.54
± 2.177
Ustekinumab 90 mg
-1.05
± 2.095
Change at Week 12
Group
Value
95% CI
Placebo
-1.00
± 2.064
Ustekinumab 45 mg
-1.69
± 2.079
Ustekinumab 90 mg
-1.35
± 2.458
Change at Week 16
Group
Value
95% CI
Placebo
-1.05
± 2.162
Ustekinumab 45 mg
-1.75
± 2.312
Ustekinumab 90 mg
-1.17
± 2.747
Change at Week 20
Group
Value
95% CI
Placebo
-1.70
± 2.339
Ustekinumab 45 mg
-2.11
± 2.394
Ustekinumab 90 mg
-1.64
± 2.794
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20Secondary· Week 4, 8, 12, 16, and 20
ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale \[NRS\]) included total back pain(TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121\*total back pain)+ (0.110\*PGA)+ (0.073\*peripheral pain/swelling)+ (0.058\* DMS)+ (0.579\*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 represent
Week 4
Group
Value
95% CI
Placebo
2.4
Ustekinumab 45 mg
3.6
Ustekinumab 90 mg
1.2
Week 8
Group
Value
95% CI
Placebo
6.1
Ustekinumab 45 mg
7.2
Ustekinumab 90 mg
9.4
Week 12
Group
Value
95% CI
Placebo
4.9
Ustekinumab 45 mg
4.8
Ustekinumab 90 mg
10.6
Week 16
Group
Value
95% CI
Placebo
6.1
Ustekinumab 45 mg
7.2
Ustekinumab 90 mg
11.8
Week 20
Group
Value
95% CI
Placebo
3.7
Ustekinumab 45 mg
13.3
Ustekinumab 90 mg
15.3
Adverse events — posted to ClinicalTrials.gov
Time frame: Approximately up to 2.2 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).
Publications & conference data
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 13 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02407223.