Trial · NCT01101100
Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
NCT01101100, Phase 2, Terminated, Bausch Health Americas, Inc.; results first posted 2019-07-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis. Trials, record NCT01101100. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01101100
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
- NCT number
- NCT01101100
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 181 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Psoriasis
- Interventions
- AMG 827
- First posted
- 2010-04-09
- Last updated
- 2019-07-30
- Results first posted
- 2019-07-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1) | 264 weeks | Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1) |
| Primary | Percent Change in Psoriasis Area and Severity Index (PASI) | 264 weeks | Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1) | 264 weeks | Subjects who were enrolled and had a valid measurement value at the specified week. Results are presented for data up to week 264 as all continuing subjects had completed that visit. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percent Change in Psoriasis Area and Severity Index (PASI) | 264 weeks | Subjects who were enrolled and had a valid measurement value at the specified week. Results are presented for data up to week 264 as all continuing subjects had completed that visit. | Percentage change | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1) | Open Label AMG 827 | 66 | Participants | ||
| Percent Change in Psoriasis Area and Severity Index (PASI) | Open Label | -85.7 | Standard Deviation 26.3 | Percentage change |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open Label AMG 827 | 181 | |
| Overall Study | COMPLETED | Open Label AMG 827 | 126 | |
| Overall Study | NOT COMPLETED | Open Label AMG 827 | 55 |
Source ClinicalTrials.gov
Adverse events65
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 | Nasopharyngitis | General disorders | Open Label AMG 827 | 53 | 181 | |
| other | Upper respiratory tract infection | Infections and infestations | Open Label AMG 827 | 43 | 181 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Open Label AMG 827 | 37 | 181 | |
| other | Influenza | Infections and infestations | Open Label AMG 827 | 28 | 181 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Open Label AMG 827 | 26 | 181 | |
| other | Gastroenteritis | Gastrointestinal disorders | Open Label AMG 827 | 24 | 181 | |
| other | Sinusitis | Infections and infestations | Open Label AMG 827 | 21 | 181 | |
| other | Psoriasis | Skin and subcutaneous tissue disorders | Open Label AMG 827 | 19 | 181 | |
| other | Hypertension | Nervous system disorders | Open Label AMG 827 | 18 | 181 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Open Label AMG 827 | 18 | 181 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open Label AMG 827 | 1 | 181 |
| Total, other adverse events | Open Label AMG 827 | 177 | 181 |
| Total, serious adverse events | Open Label AMG 827 | 29 | 181 |
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/NCT01101100
GET https://conductscience.org/api/trials/v1/NCT01101100/events?page=2