Trial · NCT00975637
Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
NCT00975637, Phase 2, Completed, Bausch Health Americas, Inc.; results first posted 2016-12-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis. Trials, record NCT00975637. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00975637
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
- NCT number
- NCT00975637
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 198 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Psoriasis
- Interventions
- 70 mg SC, 210 mg SC, 140 mg SC, 280 mg SC, Placebo
- First posted
- 2009-09-11
- Last updated
- 2019-06-26
- Results first posted
- 2016-12-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | Baseline and 12 weeks | At screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score. |
| Secondary | Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | Baseline and Week 12 | To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12. At the baseline of the study the subject would need to have at least a 10% BSA; at week 12 they were again assessed to see what change in percentage of BSA has occurred. |
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 | Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | Baseline and 12 weeks | percentage of psoriasis improvement | MEAN | |
| SECONDARY | Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | Baseline and Week 12 | percentage improvement in BSA | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | Broda 210 mg | 86.3 | Standard Deviation 27.6 | percentage of psoriasis improvement | |
| Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | Broda 140 mg | 85.9 | Standard Deviation 22.5 | percentage of psoriasis improvement | |
| Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | Broda 280 mg | 76 | Standard Deviation 32.7 | percentage of psoriasis improvement | |
| Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | Placebo | 16 | Standard Deviation 27 | percentage of psoriasis improvement | |
| Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | Broda 70 mg | 45 | Standard Deviation 41.7 | percentage of psoriasis improvement | |
| Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | Broda 210 mg | 22.1 | Standard Deviation 15.0 | percentage improvement in BSA | |
| Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | Broda 140 mg | 21.1 | Standard Deviation 16.9 | percentage improvement in BSA | |
| Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | Broda 280 mg | 16.1 | Standard Deviation 11.4 | percentage improvement in BSA | |
| Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | Placebo | 0.9 | Standard Deviation 9.7 | percentage improvement in BSA | |
| Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | Broda 70 mg | 9.2 | Standard Deviation 11.2 | percentage improvement in BSA |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 210 mg | 40 | |
| Overall Study | STARTED | 140 mg | 39 | |
| Overall Study | STARTED | 280 mg | 42 | |
| Overall Study | STARTED | Placebo | 38 | |
| Overall Study | STARTED | 70 mg | 39 | |
| Overall Study | COMPLETED | 210 mg | 37 | |
| Overall Study | COMPLETED | 140 mg | 38 | |
| Overall Study | COMPLETED | 280 mg | 40 | |
| Overall Study | COMPLETED | Placebo | 32 | |
| Overall Study | COMPLETED | 70 mg | 37 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events160
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 | Injection Site Erythema | General disorders | Broda 210 mg | 3 | 40 | |
| other | Injection Site Erythema | General disorders | Broda 140 mg | 1 | 39 | |
| other | Injection Site Erythema | General disorders | Broda 280 mg | 4 | 42 | |
| other | Injection Site Erythema | General disorders | Placebo | 1 | 38 | |
| other | Injection Site Erythema | General disorders | Broda 70 mg | 1 | 39 | |
| other | Injection Site Pain | General disorders | Broda 210 mg | 0 | 40 | |
| other | Injection Site Pain | General disorders | Broda 140 mg | 0 | 39 | |
| other | Injection Site Pain | General disorders | Broda 280 mg | 1 | 42 | |
| other | Injection Site Pain | General disorders | Placebo | 0 | 38 | |
| other | Injection Site Pain | General disorders | Broda 70 mg | 3 | 39 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Broda 210 mg | ||
| Total, all-cause mortality | Broda 140 mg | ||
| Total, all-cause mortality | Broda 280 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Broda 70 mg | ||
| Total, other adverse events | Broda 210 mg | 15 | 40 |
| Total, other adverse events | Broda 140 mg | 12 | 39 |
| Total, other adverse events | Broda 280 mg | 10 | 42 |
| Total, other adverse events | Placebo | 7 | 38 |
| Total, other adverse events | Broda 70 mg | 10 | 39 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers5
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/NCT00975637
GET https://conductscience.org/api/trials/v1/NCT00975637/events?page=2