A Phase 3 interventional study of Ustekinumab and Placebo in Takayasu Arteritis, sponsored by Janssen Pharmaceutical K.K.. Terminated at 27 sites in Japan. Open to participants aged 15 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Janssen Pharmaceutical K.K. (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of ustekinumab compared to placebo, in combination with oral glucocorticoid (GC) taper regimen, in participants with relapsing Takayasu Arteritis (TAK).
78 studies on the registry are indexed under Takayasu Arteritis; 32 are open to participants now.
This study's enrollment of 14 is below the median of 50 across 37 interventional studies indexed under Takayasu Arteritis.
Browse Takayasu Arteritis studies →Janssen Pharmaceutical K.K. is the lead sponsor of 126 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Double-blind (DB) Period: Participants will receive weight-ranged based ustekinumab (6 milligrams/kilogram\[mg/kg\]) as IV infusion at Week 0 followed by ustekinumab 90mg injection SC 8 weeks after initial IV dose, then every 8 weeks (q8w) thereafter until the end of the DB period with starting the protocol defined oral GC taper regimen from Week 2 visit. Open Label Extension (OLE) period: Participants will receive ustekinumab SC injection at Week OL-0, followed by ustekinumab 90mg SC injection with oral GC taper at investigator's discretion for 52 weeks (Week OL-52) or until 32 weeks from first SC administration after end of DB period whichever is later. Long-term Extension (LTE) Period: Participants who completed OLE period may be eligible to enter LTE and continue to receive ustekinumab 90mg SC injection q8w.
Drug: Ustekinumab · Drug: Glucorticoid Taper Regimen
DB period: Participants will receive placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then q8w thereafter until the end of DB period with starting the protocol defined oral GC taper regimen from Week 2 visit. OLE period: Participants will receive ustekinumab SC at Week OL-0, followed by SC administration of ustekinumab with oral GC taper at investigator's discretion for 52 weeks (Week OL-52) or until 32 weeks from the first SC administration after the end of DB period, whichever is later. LTE Period: Participants who complete their participation in OLE period may be eligible to enter the LTE and continue to receive 90 mg SC ustekinumab q8w.
Drug: Ustekinumab · Other: Placebo · Drug: Glucorticoid Taper Regimen
Participants will receive IV infusion and SC injection of ustekinumab.
Also known as: Stelara®, CNTO1275
Participants will receive IV infusion and SC injection of matching placebo.
Glucocorticoid will be administered orally.
Time to Relapse (ToR) of Takayasu Arteritis (TAK) According to Protocol-defined Criteria Through the End of Double-blind Period
ToR:time from randomization to 1st relapse through end of double-blind period (EDBP) per protocol-defined criteria with 5 categories:systemic (objective):body temperature \>=38.0°C, weight loss \>2kg in 4 weeks, arthralgia, swelling \& tenderness =\>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at \>= grade 2, high inflammation markers (C-reactive protein \>=1.0mg/dL, erythrocyte sedimentation rate \>=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP \<120/80mmHg risen to \>=140/90mmHg, or if normal BP \>=120/80mmHg, diastolic BP risen by \>=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by \>=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms:abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain. Relapse:\>=2 categories met criteria.
Time frame: From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study intervention. TEAEs were defined as AEs with onset or worsening on or after date of first dose of study intervention through the day of last dose.
Time frame: Double-blind period: Double-blind Week 0 up to end of double-blind treatment period (56.1 weeks); OLE period: OL Week 0 up to end of OLE treatment period (48.1 weeks)
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs were defined as SAEs with onset or worsening on or after date of first dose of study intervention through the day of last dose.
Time frame: Double-blind period: Double-blind Week 0 up to end of double-blind treatment period (56.1 weeks); OLE: OL Week 0 up to end of OLE treatment period (48.1 weeks)
Time to Relapse of TAK According to Kerr's Criteria Through the End of Double-blind Period
ToR was defined from the date of randomization to the judged date of relapse through the EDBP based on Kerr's definition: participants who met 2 or more categories in the following 4 categories were considered as relapse: systemic (objective):body temperature \>=38.0°C, weight loss \>2kg in 4 weeks, arthralgia, swelling \& tenderness =\>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at \>= grade 2, high inflammation markers (C-reactive protein \>=1.0mg/dL, erythrocyte sedimentation rate \>=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP \<120/80mmHg risen to \>=140/90mmHg, or if normal BP \>=120/80mmHg, diastolic BP risen by \>=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by \>=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms:abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain.
Time frame: From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks)
Time to Relapse of TAK Based on Clinical Symptoms Through the End of Double-blind Period
Time (in weeks) to relapse of TAK: time from randomization to the 1st relapse through the EDBP according to protocol-defined criteria with 5 categories: systemic (objective):body temperature \>=38.0°C, weight loss \>2kg in 4 weeks, arthralgia, swelling and tenderness =\>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at \>= grade 2, high inflammation markers (C-reactive protein \>=1.0mg/dL, erythrocyte sedimentation rate \>=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP \<120/80mmHg risen to \>=140/90mmHg, or if normal BP \>=120/80mmHg, diastolic BP risen by \>=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by \>=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms:abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain. Time to relapse was calculated by each category independently. Relapse:\>=2 categories met criteria.
Time frame: From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks)
Time to Relapse of TAK in Each of the 5 Categories (Within Protocol-defined Criteria) Through the End of Double-blind Period
Time to relapse of TAK: time from randomization date to the 1st relapse through the EDBP according to protocol-defined criteria with 5 categories: systemic (objective):body temperature \>=38.0°C, weight loss \>2kg in 4 weeks, arthralgia, swelling and tenderness =\>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at \>= grade 2, high inflammation markers (C-reactive protein \>=1.0mg/dL, erythrocyte sedimentation rate \>=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP \<120/80mmHg risen to \>=140/90mmHg, or if normal BP \>=120/80mmHg, diastolic BP risen by \>=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by \>=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms:abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain. Time to relapse was calculated by each category independently. Relapse:\>=2 categories met criteria.
Time frame: From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks)
Percentage of Participants With Relapse of TAK in Each of the 5 Categories (Within Protocol-defined Criteria) Through the End of Double-blind Period
Percentage of participants with time to relapse of TAK through the EDBP were reported. Protocol-defined criteria consisted of 5 categories: systemic (objective):body temperature \>=38.0°C, weight loss \>2kg in 4 weeks, arthralgia, swelling \& tenderness =\>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at \>= grade 2, high inflammation markers (C-reactive protein \>=1.0mg/dL, erythrocyte sedimentation rate \>=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP \<120/80mmHg risen to \>=140/90mmHg, or if normal BP \>=120/80mmHg, diastolic BP risen by \>=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by \>=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms: abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain.
Time frame: From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks)
Cumulative Oral Glucocorticoid (GC) Dose Through the End of Double-blind Period
Cumulative oral GC dose (prednisolone or equivalent) through the end of double-blind period were reported. If the participant had relapse, oral GC dose (prednisolone or equivalent) used from randomization date to last observed date prior to the date of relapse were included in the analysis and if the participant had no relapse then oral GC dose used from randomization to last observed date through the end of double-blind period were included in the analysis.
Time frame: From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks)
Change From Baseline in Oral GC Dose Through the End of Double-blind Period
Change from baseline in oral GC dose through the end of double-blind period were reported. Change from baseline was defined as the change between the GC dose at randomization and the last observed GC dose. If the participant had relapse, oral GC dose (prednisolone or equivalent) used from randomization date to last observed date prior to the date of relapse were included in the analysis and if the participant had no relapse then oral GC dose used from randomization to last observed date through the end of double-blind period were included in the analysis.
Time frame: Baseline (double-blind Week 0) up to end of double-blind period (up to 71.1 weeks)
Number of Participants Achieving GC Dose of 5 mg/Day or Less Through the End of Double-blind Period
Number of participants who achieved GC dose of 5 mg/day or less through the end of double-blind period were reported.
Time frame: From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks)
Change From Baseline in Imaging Evaluation of Vessel Involvement (Average Percentage of Dilation) at the End of Double-blind Period
Change from baseline in average percentage of dilation for abnormal vessel segments through the end of double-blind period was reported. Assessment was performed using computed tomography angiography (CTA) or magnetic resonance angiography (MRA). For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
Time frame: Baseline (double-blind Week 0) and double-blind relapse (up to 14 weeks for Placebo arm; up to 48 weeks for ustekinumab arm)
Change From Baseline in Imaging Evaluation of Vessel Involvement (Average Percentage of Stenosis) Through the End of Double-blind Period
Change from baseline in average percentage of stenosis for abnormal vessel segments through the end of double-blind period was reported. Assessment was performed using CTA or MRA. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
Time frame: Baseline (double-blind Week 0), Week 24, Week 48, and double-blind relapse (up to 14 weeks for Placebo arm; up to 48 weeks for ustekinumab arm)
Change From Baseline in Imaging Evaluation of Average Arterial Wall Thickness Through the End of Double-blind Period
Change from baseline in average wall thickness for abnormal segments through the end of double-blind period was reported. Assessment was performed using CTA or MRA. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
Time frame: Baseline (double-blind Week 0), Week 24, Week 48, and double-blind relapse (up to 14 weeks for Placebo arm; up to 48 weeks for ustekinumab arm)
Imaging Evaluation: Number of Participants With Mural Contrast Enhancement Through the End of Double-blind Period
Number of participants with mural contrast enhancement through the end of double-blind period were reported. The mural contrast enhancement were assessed for imaging evaluation using CTA or MRA. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
Time frame: Baseline (double-blind Week 0), Week 24, Week 48, and double-blind relapse (up to 14 weeks for Placebo arm; up to 48 weeks for ustekinumab arm)
Change From Baseline in C-reactive Protein (CRP) Through the End of Double-blind Period
Change from baseline in CRP (as inflammatory marker) through the end of double-blind period were reported. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
Time frame: Baseline (double-blind Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and double-blind relapse (up to 14 weeks for Placebo arm; up to 48 weeks for ustekinumab arm)
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Through the End of Double-blind Period
Change from baseline in ESR (as inflammatory marker) through the end of double-blind period were reported. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
Time frame: Baseline (double-blind Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and double-blind relapse (up to 14 weeks for Placebo arm; up to 48 weeks for ustekinumab arm)
Serum Concentrations of Ustekinumab in Participants Receiving Ustekinumab During Double-blind Phase
Serum concentrations of ustekinumab was reported during double-blind Phase. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
Time frame: Pre-dose (double-blind Week 0), Post-dose: Week 0, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, double-blind relapse (up to 48 weeks)
Serum Concentrations of Ustekinumab in Participants Receiving Ustekinumab During Open-label Extension Phase
Serum concentrations of ustekinumab was reported during OLE Phase.
Time frame: Pre-dose (OL Week 0), Post-dose: OL Week 0, OL Weeks 8, 16, 24, 32, 40, 48, 52, and 56
Number of Participants With Positive Anti-ustekinumab Antibodies Through End of Double-blind Period
Number of participants with positive anti-ustekinumab antibodies were reported.
Time frame: From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks)
Number of Participants With Positive Anti-ustekinumab Antibodies Through End of OLE Period
Number of participants with positive anti-ustekinumab antibodies were reported.
Time frame: From OL Week 0 up to end of OLE period (up to 63.1 weeks)
Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study intervention. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study intervention through the day of last dose. If same participant had more than one AE within the same SOC, that participant is counted only once in the below data table.
Time frame: Double-blind period: double-blind Week 0 up to end of double-blind treatment period (56.1 weeks); OLE period: OL Week 0 up to end of OLE treatment period (48.1 weeks)
| Milestone | Placebo Then Ustekinumab | Ustekinumab Then Ustekinumab |
|---|---|---|
| Started | 8 | 6 |
| Completed | 6 | 6 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Withdrawal criterion met | 1 | 0 |
| Milestone | Placebo Then Ustekinumab | Ustekinumab Then Ustekinumab |
|---|---|---|
| Started | 3 | 4 |
| Completed | 3 | 3 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
ToR:time from randomization to 1st relapse through end of double-blind period (EDBP) per protocol-defined criteria with 5 categories:systemic (objective):body temperature \>=38.0°C, weight loss \>2kg in 4 weeks, arthralgia, swelling \& tenderness =\>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at \>= grade 2, high inflammation markers (C-reactive protein \>=1.0mg/dL, erythrocyte sedimentation rate \>=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP \<120/80mmHg risen to \>=140/90mmHg, or if normal BP \>=120/80mmHg, diastolic BP risen by \>=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by \>=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms:abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain. Relapse:\>=2 categories met criteria.
| Weeks | Double-blind: Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Time to Relapse (ToR) of Takayasu Arteritis (TAK) According to Protocol-defined Criteria Through the End of Double-blind Period | 12.64 (12.14 to NA) | 11.14 (4.14 to NA) |
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study intervention. TEAEs were defined as AEs with onset or worsening on or after date of first dose of study intervention through the day of last dose.
| Participants | Double-blind: Placebo | Double-blind: Ustekinumab | OLE: Placebo Then Ustekinumab | OLE: Ustekinumab Then Ustekinumab |
|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 6 | 5 | 1 | 2 |
SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs were defined as SAEs with onset or worsening on or after date of first dose of study intervention through the day of last dose.
| Participants | Double-blind: Placebo | Double-blind: Ustekinumab | OLE: Placebo Then Ustekinumab | OLE: Ustekinumab Then Ustekinumab |
|---|---|---|---|---|
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | 1 | 1 | 0 | 1 |
ToR was defined from the date of randomization to the judged date of relapse through the EDBP based on Kerr's definition: participants who met 2 or more categories in the following 4 categories were considered as relapse: systemic (objective):body temperature \>=38.0°C, weight loss \>2kg in 4 weeks, arthralgia, swelling \& tenderness =\>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at \>= grade 2, high inflammation markers (C-reactive protein \>=1.0mg/dL, erythrocyte sedimentation rate \>=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP \<120/80mmHg risen to \>=140/90mmHg, or if normal BP \>=120/80mmHg, diastolic BP risen by \>=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by \>=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms:abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain.
| Weeks | Double-blind: Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Time to Relapse of TAK According to Kerr's Criteria Through the End of Double-blind Period | 12.64 (12.14 to NA) | 11.14 (4.14 to NA) |
Time (in weeks) to relapse of TAK: time from randomization to the 1st relapse through the EDBP according to protocol-defined criteria with 5 categories: systemic (objective):body temperature \>=38.0°C, weight loss \>2kg in 4 weeks, arthralgia, swelling and tenderness =\>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at \>= grade 2, high inflammation markers (C-reactive protein \>=1.0mg/dL, erythrocyte sedimentation rate \>=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP \<120/80mmHg risen to \>=140/90mmHg, or if normal BP \>=120/80mmHg, diastolic BP risen by \>=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by \>=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms:abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain. Time to relapse was calculated by each category independently. Relapse:\>=2 categories met criteria.
| weeks | Double-blind: Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Time to Relapse of TAK Based on Clinical Symptoms Through the End of Double-blind Period | 12.14 (2.14 to NA) | 4.14 (2.14 to NA) |
Time to relapse of TAK: time from randomization date to the 1st relapse through the EDBP according to protocol-defined criteria with 5 categories: systemic (objective):body temperature \>=38.0°C, weight loss \>2kg in 4 weeks, arthralgia, swelling and tenderness =\>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at \>= grade 2, high inflammation markers (C-reactive protein \>=1.0mg/dL, erythrocyte sedimentation rate \>=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP \<120/80mmHg risen to \>=140/90mmHg, or if normal BP \>=120/80mmHg, diastolic BP risen by \>=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by \>=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms:abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain. Time to relapse was calculated by each category independently. Relapse:\>=2 categories met criteria.
| weeks | Double-blind: Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Systemic Symptoms (Objective Assessment) | 14.00 (12.14 to NA) | NA (12.14 to NA) |
| Systemic Symptoms (Subjective Assessment) | 12.64 (12.14 to NA) | 10.00 (2.14 to NA) |
| Elevated Inflammation Markers | 13.14 (8.14 to NA) | 12.14 (4.14 to NA) |
| Vascular Signs And Symptoms | 12.14 (2.14 to NA) | 7.14 (2.14 to NA) |
Percentage of participants with time to relapse of TAK through the EDBP were reported. Protocol-defined criteria consisted of 5 categories: systemic (objective):body temperature \>=38.0°C, weight loss \>2kg in 4 weeks, arthralgia, swelling \& tenderness =\>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at \>= grade 2, high inflammation markers (C-reactive protein \>=1.0mg/dL, erythrocyte sedimentation rate \>=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP \<120/80mmHg risen to \>=140/90mmHg, or if normal BP \>=120/80mmHg, diastolic BP risen by \>=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by \>=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms: abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain.
| percentage of participants | Double-blind: Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Systemic Symptoms (Objective Assessment) | 25.0 | 16.7 |
| Systemic Symptoms (Subjective Assessment) | 37.5 | 50.0 |
| Elevated Inflammation Markers | 50.0 | 50.0 |
| Vascular Signs And Symptoms | 50.0 | 100.0 |
| Ischemic Symptoms | 0 | 0 |
Cumulative oral GC dose (prednisolone or equivalent) through the end of double-blind period were reported. If the participant had relapse, oral GC dose (prednisolone or equivalent) used from randomization date to last observed date prior to the date of relapse were included in the analysis and if the participant had no relapse then oral GC dose used from randomization to last observed date through the end of double-blind period were included in the analysis.
| milligrams (mg) | Double-blind: Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Cumulative Oral Glucocorticoid (GC) Dose Through the End of Double-blind Period | 1043.6 ± 367.27 | 1319.1 ± 697.67 |
Change from baseline in oral GC dose through the end of double-blind period were reported. Change from baseline was defined as the change between the GC dose at randomization and the last observed GC dose. If the participant had relapse, oral GC dose (prednisolone or equivalent) used from randomization date to last observed date prior to the date of relapse were included in the analysis and if the participant had no relapse then oral GC dose used from randomization to last observed date through the end of double-blind period were included in the analysis.
| milligrams per day (mg/day) | Double-blind: Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Change From Baseline in Oral GC Dose Through the End of Double-blind Period | -11.3 ± 3.73 | -12.1 ± 6.25 |
Number of participants who achieved GC dose of 5 mg/day or less through the end of double-blind period were reported.
| Participants | Double-blind: Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Number of Participants Achieving GC Dose of 5 mg/Day or Less Through the End of Double-blind Period | 3 | 1 |
Change from baseline in average percentage of dilation for abnormal vessel segments through the end of double-blind period was reported. Assessment was performed using computed tomography angiography (CTA) or magnetic resonance angiography (MRA). For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
| Percentage of Dilation | Double-blind: Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Change From Baseline in Imaging Evaluation of Vessel Involvement (Average Percentage of Dilation) at the End of Double-blind Period | — | -3.95 ± 5.586 |
Change from baseline in average percentage of stenosis for abnormal vessel segments through the end of double-blind period was reported. Assessment was performed using CTA or MRA. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
| Percentage of Stenosis | Double-blind: Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Double-blind Week 24 | — | -11.39 ± NA |
| Double-blind Week 48 | — | -12.62 ± NA |
| Double-blind Relapse | -7.15 ± 10.105 | -13.94 ± 22.24 |
Change from baseline in average wall thickness for abnormal segments through the end of double-blind period was reported. Assessment was performed using CTA or MRA. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
| millimeters | Double-blind : Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Double-blind Week 24 | — | -1.25 ± NA |
| Double-blind Week 48 | — | -1.25 ± NA |
| Double-blind Relapse | -1.00 ± NA | 1.00 ± NA |
Number of participants with mural contrast enhancement through the end of double-blind period were reported. The mural contrast enhancement were assessed for imaging evaluation using CTA or MRA. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
| Participants | Double-blind: Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Baseline (Week 0) | 1 | 1 |
| Double-blind Week 24 | — | 1 |
| Double-blind Week 48 | — | 1 |
| Double-blind Relapse | 0 | 1 |
Change from baseline in CRP (as inflammatory marker) through the end of double-blind period were reported. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
| milligrams per deciliter (mg/dL) | Double-blind: Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Double-blind Week 2 | -0.003 ± 0.0539 | 0.558 ± 0.9585 |
| Double-blind Week 4 | 0.529 ± 1.4639 | 0.858 ± 1.6216 |
| Double-blind Week 8 | 0.918 ± 1.3851 | 0.333 ± 0.3505 |
| Double-blind Week 12 | 1.475 ± 0.5132 | 1.170 ± 1.0333 |
| Double-blind Week 16 | — | -0.010 ± NA |
| Double-blind Week 20 | — | -0.030 ± NA |
| Double-blind Week 24 | — | 0.00 ± NA |
| Double-blind Week 28 | — | 0.00 ± NA |
| Double-blind Week 32 | — | 0.310 ± NA |
| Double-blind Week 36 | — | 0.060 ± NA |
| Double-blind Week 40 | — | -0.020 ± NA |
| Double-blind Week 44 | — | 0.300 ± NA |
| Double-blind Week 48 | — | -0.010 ± NA |
| Double-blind Week 52 | — | 0.010 ± NA |
| Double-blind Week 56 | — | 0.130 ± NA |
| Double-blind Relapse | 2.043 ± 1.5661 | 2.598 ± 3.2988 |
Change from baseline in ESR (as inflammatory marker) through the end of double-blind period were reported. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
| millimeters per hour (mm/h) | Double-blind: Placebo | Double-blind: Ustekinumab |
|---|---|---|
| Double-blind Week 2 | 0.13 ± 1.246 | 1.20 ± 8.349 |
| Double-blind Week 4 | 4.75 ± 11.841 | 4.33 ± 17.397 |
| Double-blind Week 8 | 6.67 ± 4.131 | 5.13 ± 7.028 |
| Double-blind Week 12 | 24.25 ± 15.174 | 15.50 ± 15.174 |
| Double-blind Week 16 | — | 1.00 ± NA |
| Double-blind Week 20 | — | -2.00 ± NA |
| Double-blind Week 24 | — | -2.00 ± NA |
| Double-blind Week 28 | — | 12.00 ± NA |
| Double-blind Week 32 | — | 13.00 ± NA |
| Double-blind Week 36 | — | 2.00 ± NA |
| Double-blind Week 40 | — | 2.00 ± NA |
| Double-blind Week 44 | — | 0.00 ± NA |
| Double-blind Week 48 | — | -2.00 ± NA |
| Double-blind Week 52 | — | -2.00 ± NA |
| Double-blind Week 56 | — | 20.00 ± NA |
| Double-blind Relapse | 28.25 ± 15.500 | 18.63 ± 9.741 |
Serum concentrations of ustekinumab was reported during double-blind Phase. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period.
| micrograms per millilitres (mcg/mL) | Double-blind: Ustekinumab |
|---|---|
| Pre-dose (Week 0) | NA ± NA |
| Post-dose (Week 0) | 135.644 ± 33.2099 |
| Week 2 | 40.470 ± 8.5492 |
| Week 4 | 21.630 ± 3.5437 |
| Week 8 | 8.663 ± 2.9795 |
| Week 12 | 7.762 ± 0.7537 |
| Week 16 | 3.811 ± NA |
| Week 20 | 4.970 ± NA |
| Week 24 | 2.195 ± NA |
| Week 28 | 5.323 ± NA |
| Week 32 | 2.033 ± NA |
| Week 36 | 3.984 ± NA |
| Week 40 | 1.695 ± NA |
| Week 44 | 4.958 ± NA |
| Week 48 | 2.121 ± NA |
| Week 52 | 6.447 ± NA |
| Week 56 | 2.596 ± NA |
| Week 60 | 3.244 ± NA |
| Double-blind: Relapse | 13.437 ± NA |
Serum concentrations of ustekinumab was reported during OLE Phase.
| mcg/mL | OLE: Placebo Then Ustekinumab | OLE: Ustekinumab Then Ustekinumab |
|---|---|---|
| Pre-dose OL Week 0 | NA ± NA | 4.765 ± 2.1977 |
| Post-dose OL Week 0 | 126.394 ± 15.5782 | 132.580 ± 36.2574 |
| OL Week 8 | 15.830 ± 7.3113 | 10.912 ± 4.5891 |
| OL Week 16 | 7.253 ± NA | 7.560 ± NA |
| OL Week 24 | 8.844 ± 4.3775 | 4.807 ± NA |
| OL Week 32 | 6.096 ± NA | 3.870 ± NA |
| OL Week 40 | 3.911 ± NA | 3.911 ± NA |
| OL Week 48 | 3.719 ± NA | — |
| OL Week 52 | 9.676 ± NA | — |
| OL Week 56 | 3.710 ± NA | — |
Number of participants with positive anti-ustekinumab antibodies were reported.
| Participants | Double-blind: Ustekinumab |
|---|---|
| Number of Participants With Positive Anti-ustekinumab Antibodies Through End of Double-blind Period | 0 |
Number of participants with positive anti-ustekinumab antibodies were reported.
| Participants | OLE: Placebo Then Ustekinumab | OLE: Ustekinumab Then Ustekinumab |
|---|---|---|
| Number of Participants With Positive Anti-ustekinumab Antibodies Through End of OLE Period | 0 | 0 |
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study intervention. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study intervention through the day of last dose. If same participant had more than one AE within the same SOC, that participant is counted only once in the below data table.
| Participants | Double-blind: Placebo | Double-blind: Ustekinumab | OLE: Placebo Then Ustekinumab | OLE: Ustekinumab Then Ustekinumab |
|---|---|---|---|---|
| Ear and Labyrinth Disorders | 0 | 1 | 0 | 0 |
| Eye Disorders | 2 | 2 | 0 | 0 |
| Gastrointestinal Disorders | 3 | 0 | 1 | 2 |
| General Disorders and Administration Site Conditions | 0 | 4 | 0 | 2 |
| Infections and Infestations | 1 | 6 | 0 | 0 |
| Injury, Poisoning and Procedural Complications | 1 | 3 | 1 | 1 |
| Investigations | 0 | 1 | 0 | 1 |
| Metabolism and Nutrition Disorders | 0 | 1 | 0 | 0 |
| Musculoskeletal and Connective Tissue Disorders | 1 | 1 | 0 | 0 |
| Nervous System Disorders | 0 | 5 | 1 | 1 |
| Respiratory, Thoracic and Mediastinal Disorders | 0 | 0 | 0 | 2 |
| Skin and Subcutaneous Tissue Disorders | 4 | 0 | 0 | 0 |
| Vascular Disorders | 1 | 2 | 0 | 1 |
Collected over Double-blind period: From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks); OLE period: From OL-Week 0 up to end of OLE period (up to 63.1 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Double Blind: Placebo | 0/8 (0%) | 1/8 (12.5%) | 6/8 (75%) |
| Double-blind: Ustekinumab | 0/6 (0%) | 1/6 (16.7%) | 5/6 (83.3%) |
| OLE Period: Placebo Then Ustekinumab | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| OLE Period: Ustekinumab Then Ustekinumab | 0/4 (0%) | 1/4 (25%) | 2/4 (50%) |
| Event | Double Blind: Placebo | Double-blind: Ustekinumab | OLE Period: Placebo Then Ustekinumab | OLE Period: Ustekinumab Then Ustekinumab |
|---|---|---|---|---|
| Vascular Graft InfectionInfections and infestations | 0/8 | 0/6 | 0/3 | 1/4 |
| Vascular PseudoaneurysmInjury, poisoning and procedural complications | 0/8 | 1/6 | 0/3 | 0/4 |
| Brachiocephalic Artery StenosisVascular disorders | 0/8 | 1/6 | 0/3 | 0/4 |
| CholecystitisHepatobiliary disorders | 1/8 | 0/6 | 0/3 | 0/4 |
| Event | Double Blind: Placebo | Double-blind: Ustekinumab | OLE Period: Placebo Then Ustekinumab | OLE Period: Ustekinumab Then Ustekinumab |
|---|---|---|---|---|
| GastritisGastrointestinal disorders | 0/8 | 0/6 | 1/3 | 0/4 |
| PyrexiaGeneral disorders | 0/8 | 2/6 | 0/3 | 1/4 |
| Vaccination Site PainGeneral disorders | 0/8 | 2/6 | 0/3 | 0/4 |
| ChillblainsInjury, poisoning and procedural complications | 0/8 | 0/6 | 1/3 | 0/4 |
| Carpal Tunnel SyndromeNervous system disorders | 0/8 | 0/6 | 1/3 | 0/4 |
| HeadacheNervous system disorders | 0/8 | 1/6 | 1/3 | 0/4 |
| Takayasu's ArteritisVascular disorders | 1/8 | 2/6 | 0/3 | 0/4 |
| Coating in MouthGastrointestinal disorders | 0/8 | 0/6 | 0/3 | 1/4 |
| DiarrhoeaGastrointestinal disorders | 1/8 | 0/6 | 0/3 | 1/4 |
| MalaiseGeneral disorders | 0/8 | 0/6 | 0/3 | 1/4 |
| Age, Categorical(Participants) | Placebo Then Ustekinumab | Ustekinumab Then Ustekinumab | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 6 | 12 |
| >=65 years | 2 | 0 | 2 |
| Age, Continuous(years) | Placebo Then Ustekinumab | Ustekinumab Then Ustekinumab | Total |
|---|---|---|---|
| Mean | 49.6 ± 15.46 | 36.5 ± 12.19 | 44 ± 15.21 |
| Sex: Female, Male(Participants) | Placebo Then Ustekinumab | Ustekinumab Then Ustekinumab | Total |
|---|---|---|---|
| Female | 7 | 4 | 11 |
| Male | 1 | 2 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Placebo Then Ustekinumab | Ustekinumab Then Ustekinumab | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 8 | 6 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo Then Ustekinumab | Ustekinumab Then Ustekinumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 6 | 14 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo Then Ustekinumab | Ustekinumab Then Ustekinumab | Total |
|---|---|---|---|
| Japan | 8 | 6 | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · www.janssen.com
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Studies of the drug tested here: Ustekinumab