Trial · NCT02199496
Study of Safety, Tolerability, and Efficacy of Ustekinumab for Symptomatic Gastrointestinal Inflammation Associated With Common Variable Immunodeficiency
NCT02199496, Phase 1, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2020-08-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Safety, Tolerability, and Efficacy of Ustekinumab for Symptomatic Gastrointestinal Inflammation Associated With Common Variable Immunodeficiency. Trials, record NCT02199496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02199496
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Safety, Tolerability, and Efficacy of Ustekinumab for Symptomatic Gastrointestinal Inflammation Associated With Common Variable Immunodeficiency
- NCT number
- NCT02199496
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Gastrointestinal Inflammation Associated With CVID, CVID Enteropathy
- Interventions
- Stelara (ustekinumab)
- First posted
- 2014-07-24
- Last updated
- 2020-08-24
- Results first posted
- 2020-08-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Increase in Infection or Serious Adverse Events (SAEs) Related to Single Dose Administration of Ustekinumab | 6 months | Whether treatment with ustekinumab is safe and tolerated in patients with common variable immunodeficiency (CVID) enteropathy as determined by no significant increase in infection or serious adverse events |
| Primary | Number of Participants With Increase in Infection or Serious Adverse Events (SAEs) Related to Multi-dose Administration of Ustekinumab (Cohort 1) | 48 weeks | Whether treatment with ustekinumab is safe and tolerated in patients with common variable immunodeficiency (CVID) enteropathy as determined by no significant increase in infection or serious adverse events |
| Primary | Number of Participants With Increase in Infection or Serious Adverse Events (SAEs) Related to Multi-dose Administration of Ustekinumab (Cohort 2) | 48 weeks | Whether treatment with ustekinumab is safe and tolerated in patients with common variable immunodeficiency (CVID) enteropathy as determined by no significant increase in infection or serious adverse events |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Increase in Infection or Serious Adverse Events (SAEs) Related to Single Dose Administration of Ustekinumab | 6 months | Participants who received ustekinumab | participants | NUMBER |
| PRIMARY | Number of Participants With Increase in Infection or Serious Adverse Events (SAEs) Related to Multi-dose Administration of Ustekinumab (Cohort 1) | 48 weeks | Participants who received ustekinumab | participants | NUMBER |
| PRIMARY | Number of Participants With Increase in Infection or Serious Adverse Events (SAEs) Related to Multi-dose Administration of Ustekinumab (Cohort 2) | 48 weeks | Participants who received ustekinumab | participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Increase in Infection or Serious Adverse Events (SAEs) Related to Single Dose Administration of Ustekinumab | Cohort 1: Ustekinumab-Single Dose Phase 1 | 0 | participants | ||
| Number of Participants With Increase in Infection or Serious Adverse Events (SAEs) Related to Multi-dose Administration of Ustekinumab (Cohort 1) | Cohort 1: Ustekinumab-Multi-dose Phase 2 | 0 | participants | ||
| Number of Participants With Increase in Infection or Serious Adverse Events (SAEs) Related to Multi-dose Administration of Ustekinumab (Cohort 2) | Cohort 2: Ustekinumab-Multi-dose Phase 2 | 0 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Ustekinumab-Single Dose | STARTED | Cohort 1: Single-dose Phase 1, Multi-dose Phase 2 | 3 | |
| Ustekinumab-Single Dose | STARTED | Cohort 2: Multi-Dose Ustekinumab Phase 2 | 0 | |
| Ustekinumab-Single Dose | COMPLETED | Cohort 1: Single-dose Phase 1, Multi-dose Phase 2 | 3 | |
| Ustekinumab-Single Dose | COMPLETED | Cohort 2: Multi-Dose Ustekinumab Phase 2 | 0 | |
| Ustekinumab-Single Dose | NOT COMPLETED | Cohort 1: Single-dose Phase 1, Multi-dose Phase 2 | 0 | |
| Ustekinumab-Single Dose | NOT COMPLETED | Cohort 2: Multi-Dose Ustekinumab Phase 2 | 0 | |
| Ustekinumab-Multi-dose | STARTED | Cohort 1: Single-dose Phase 1, Multi-dose Phase 2 | 3 | |
| Ustekinumab-Multi-dose | STARTED | Cohort 2: Multi-Dose Ustekinumab Phase 2 | 2 | |
| Ustekinumab-Multi-dose | COMPLETED | Cohort 1: Single-dose Phase 1, Multi-dose Phase 2 | 3 | |
| Ustekinumab-Multi-dose | COMPLETED | Cohort 2: Multi-Dose Ustekinumab Phase 2 | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events381
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 | Anaemia | Blood and lymphatic system disorders | Cohort 1: Ustekinumab-Single Dose Phase 1 | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: Ustekinumab-Multi-dose Phase 2 | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Ustekinumab-Multi-dose Phase 2 | 1 | 2 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Cohort 1: Ustekinumab-Single Dose Phase 1 | 0 | 3 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Cohort 1: Ustekinumab-Multi-dose Phase 2 | 1 | 3 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Cohort 2: Ustekinumab-Multi-dose Phase 2 | 0 | 2 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Cohort 1: Ustekinumab-Single Dose Phase 1 | 1 | 3 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Cohort 1: Ustekinumab-Multi-dose Phase 2 | 0 | 3 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Cohort 2: Ustekinumab-Multi-dose Phase 2 | 0 | 2 | |
| other | Splenomegaly | Blood and lymphatic system disorders | Cohort 1: Ustekinumab-Single Dose Phase 1 | 0 | 3 |
1 to 10 of 381Source ClinicalTrials.gov
See all 381 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Ustekinumab-Single Dose Phase 1 | 0 | 3 |
| Total, all-cause mortality | Cohort 1: Ustekinumab-Multi-dose Phase 2 | 0 | 3 |
| Total, all-cause mortality | Cohort 2: Ustekinumab-Multi-dose Phase 2 | 0 | 2 |
| Total, other adverse events | Cohort 1: Ustekinumab-Single Dose Phase 1 | 3 | 3 |
| Total, other adverse events | Cohort 1: Ustekinumab-Multi-dose Phase 2 | 3 | 3 |
| Total, other adverse events | Cohort 2: Ustekinumab-Multi-dose Phase 2 | 2 | 2 |
| Total, serious adverse events | Cohort 1: Ustekinumab-Single Dose Phase 1 | 0 | 3 |
| Total, serious adverse events | Cohort 1: Ustekinumab-Multi-dose Phase 2 | 1 | 3 |
| Total, serious adverse events | Cohort 2: Ustekinumab-Multi-dose Phase 2 | 2 | 2 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02199496
GET https://conductscience.org/api/trials/v1/NCT02199496/events?page=2