Trial · NCT04882072
A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK)
NCT04882072, Phase 3, Terminated, Janssen Pharmaceutical K.K.; results first posted 2024-12-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK). Trials, record NCT04882072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04882072
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK)
- NCT number
- NCT04882072
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 14 participants, actual
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Conditions
- Takayasu Arteritis
- Interventions
- Ustekinumab, Placebo, Glucorticoid Taper Regimen
- First posted
- 2021-05-11
- Last updated
- 2025-04-29
- Results first posted
- 2024-12-02
- Limitations and caveats
- The study was terminated early by the sponsor due to difficulties in participant recruitment.
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Relapse (ToR) of Takayasu Arteritis (TAK) According to Protocol-defined Criteria Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | 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. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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) | 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. |
| Secondary | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | 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) | 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. |
| Secondary | Time to Relapse of TAK According to Kerr's Criteria Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | 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. |
| Secondary | Time to Relapse of TAK Based on Clinical Symptoms Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | 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. |
| Secondary | Time to Relapse of TAK in Each of the 5 Categories (Within Protocol-defined Criteria) Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | 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. |
| Secondary | Percentage of Participants With Relapse of TAK in Each of the 5 Categories (Within Protocol-defined Criteria) Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | 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. |
| Secondary | Cumulative Oral Glucocorticoid (GC) Dose Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | 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. |
| Secondary | Change From Baseline in Oral GC Dose Through the End of Double-blind Period | Baseline (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 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. |
| Secondary | Number of Participants Achieving GC Dose of 5 mg/Day or Less Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | Number of participants who achieved GC dose of 5 mg/day or less through the end of double-blind period were reported. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Relapse (ToR) of Takayasu Arteritis (TAK) According to Protocol-defined Criteria Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | Full analysis set (FAS) included all randomized participants who received at least 1 dose of study intervention through double-blind period. Censored:death/discontinued drugs at last assessment through EDBP (before relapse)/before EDBP (no relapse). | Weeks | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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) | The safety analysis set included all participants who received at least 1 dose of study intervention through double-blind period and OLE period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | 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) | The safety analysis set included all participants who received at least 1 dose of study intervention through double-blind period and OLE period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Relapse of TAK According to Kerr's Criteria Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. | Weeks | MEDIAN |
| SECONDARY | Time to Relapse of TAK Based on Clinical Symptoms Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | FAS included all randomized participants who received at least 1 dose of study intervention through double-blind period. | weeks | MEDIAN |
| SECONDARY | Time to Relapse of TAK in Each of the 5 Categories (Within Protocol-defined Criteria) Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. Here, '0' in the number analyzed field signifies that no participants were in relapse. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Relapse of TAK in Each of the 5 Categories (Within Protocol-defined Criteria) Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Oral Glucocorticoid (GC) Dose Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. | milligrams (mg) | MEAN |
| SECONDARY | Change From Baseline in Oral GC Dose Through the End of Double-blind Period | Baseline (double-blind Week 0) up to end of double-blind period (up to 71.1 weeks) | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. | milligrams per day (mg/day) | MEAN |
| SECONDARY | Number of Participants Achieving GC Dose of 5 mg/Day or Less Through the End of Double-blind Period | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group186
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Relapse (ToR) of Takayasu Arteritis (TAK) According to Protocol-defined Criteria Through the End of Double-blind Period | Double-blind: Placebo | 12.64 | 95% Confidence Interval 12.14 to NA | Weeks | |
| Time to Relapse (ToR) of Takayasu Arteritis (TAK) According to Protocol-defined Criteria Through the End of Double-blind Period | Double-blind: Ustekinumab | 11.14 | 95% Confidence Interval 4.14 to NA | Weeks | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Double-blind: Placebo | 6 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Double-blind: Ustekinumab | 5 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | OLE: Placebo Then Ustekinumab | 1 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | OLE: Ustekinumab Then Ustekinumab | 2 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | Double-blind: Placebo | 1 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | Double-blind: Ustekinumab | 1 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | OLE: Placebo Then Ustekinumab | 0 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | OLE: Ustekinumab Then Ustekinumab | 1 | Participants |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind: Week 0 to Week 71.1 | STARTED | Placebo Then Ustekinumab | 8 | |
| Double Blind: Week 0 to Week 71.1 | STARTED | Ustekinumab Then Ustekinumab | 6 | |
| Double Blind: Week 0 to Week 71.1 | COMPLETED | Placebo Then Ustekinumab | 6 | |
| Double Blind: Week 0 to Week 71.1 | COMPLETED | Ustekinumab Then Ustekinumab | 6 | |
| Double Blind: Week 0 to Week 71.1 | NOT COMPLETED | Placebo Then Ustekinumab | 2 | |
| Double Blind: Week 0 to Week 71.1 | NOT COMPLETED | Ustekinumab Then Ustekinumab | 0 | |
| OL Extension: OL Week 0 to OL Week 63.1 | STARTED | Placebo Then Ustekinumab | 3 | |
| OL Extension: OL Week 0 to OL Week 63.1 | STARTED | Ustekinumab Then Ustekinumab | 4 | |
| OL Extension: OL Week 0 to OL Week 63.1 | COMPLETED | Placebo Then Ustekinumab | 3 | |
| OL Extension: OL Week 0 to OL Week 63.1 | COMPLETED | Ustekinumab Then Ustekinumab | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events200
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tinnitus | Ear and labyrinth disorders | Double Blind: Placebo | 0 | 8 | |
| other | Tinnitus | Ear and labyrinth disorders | Double-blind: Ustekinumab | 1 | 6 | |
| other | Tinnitus | Ear and labyrinth disorders | OLE Period: Placebo Then Ustekinumab | 0 | 3 | |
| other | Tinnitus | Ear and labyrinth disorders | OLE Period: Ustekinumab Then Ustekinumab | 0 | 4 | |
| other | Conjunctival Haemorrhage | Eye disorders | Double Blind: Placebo | 1 | 8 | |
| other | Conjunctival Haemorrhage | Eye disorders | Double-blind: Ustekinumab | 0 | 6 | |
| other | Conjunctival Haemorrhage | Eye disorders | OLE Period: Placebo Then Ustekinumab | 0 | 3 | |
| other | Conjunctival Haemorrhage | Eye disorders | OLE Period: Ustekinumab Then Ustekinumab | 0 | 4 | |
| other | Posterior Capsule Opacification | Eye disorders | Double Blind: Placebo | 0 | 8 | |
| other | Posterior Capsule Opacification | Eye disorders | Double-blind: Ustekinumab | 1 | 6 |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double Blind: Placebo | 0 | 8 |
| Total, all-cause mortality | Double-blind: Ustekinumab | 0 | 6 |
| Total, all-cause mortality | OLE Period: Placebo Then Ustekinumab | 0 | 3 |
| Total, all-cause mortality | OLE Period: Ustekinumab Then Ustekinumab | 0 | 4 |
| Total, other adverse events | Double Blind: Placebo | 6 | 8 |
| Total, other adverse events | Double-blind: Ustekinumab | 5 | 6 |
| Total, other adverse events | OLE Period: Placebo Then Ustekinumab | 1 | 3 |
| Total, other adverse events | OLE Period: Ustekinumab Then Ustekinumab | 2 | 4 |
| Total, serious adverse events | Double Blind: Placebo | 1 | 8 |
| Total, serious adverse events | Double-blind: Ustekinumab | 1 | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40104212 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Double-blind: Ustekinumab vs Double-blind: Placebo: Number of Participants Achieving GC Dose of 5 mg/Day or Less Through the End of Double-blind Period | Trial comparisons |
| OLE: Ustekinumab Then Ustekinumab vs OLE: Placebo Then Ustekinumab: Number of Participants With Positive Anti-ustekinumab Antibodies Through End of OLE Period | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04882072
GET https://conductscience.org/api/trials/v1/NCT04882072/registered?page=2