Trial record 2 of 6 for:
BIIB092
Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PASSPORT)
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| ClinicalTrials.gov Identifier: NCT03068468 |
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Recruitment Status :
Terminated
(251PP301(PASSPORT) primary endpoint was not met;Biogen decision to close the study early. There were no safety concerns with the PASSPORT study.)
First Posted : March 1, 2017
Results First Posted : December 21, 2020
Last Update Posted : December 21, 2020
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Sponsor:
Biogen
Information provided by (Responsible Party):
Biogen
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Supranuclear Palsy, Progressive |
| Interventions |
Drug: BIIB092 Drug: Placebo |
| Enrollment | 490 |
Participant Flow
| Recruitment Details | Participants were enrolled at 89 investigative sites in the United States, Australia, Austria, Canada, France, Germany, Greece, Italy, Japan, Republic of Korea, Russia Federation, Spain and United Kingdom from June 01, 2017 to February 07, 2020. |
| Pre-assignment Details | A total of 490 participants with Progressive Supranuclear Palsy disease were enrolled and randomised in the study. Of these, 486 participants received the study drug in placebo-controlled (PC) period. After completing PC period, 416 participants entered and dosed in open-label extension (OLE) period and no participants completed the study due to early termination of the study. |
| Arm/Group Title | Placebo (PC Period) | BIIB092 2000 mg (PC Period) | BIIB092 Late Start (OLE Period) | BIIB092 Early Start (OLE Period) |
|---|---|---|---|---|
 Arm/Group Description |
Participants assigned to BIIB092 matching placebo intravenous (IV) infusion once every 4 weeks for 48 weeks in double blind PC period and receive only placebo. | Participants who received at least one dose of BIIB092 2000 mg and were either assigned to BIIB092 2000 milligrams (mg) IV infusion or BIIB092 matching placebo IV infusion once every 4 weeks for 48 weeks in double blind PC period. | Late start subjects received only placebo in the placebo-controlled period and assigned to BIIB092 2000 mg IV infusion once every 4 weeks starting at Week 52 in the OLE period. | Early start subjects are those who received BIIB092 2000 mg in the placebo-controlled period and assigned to BIIB092 2000 mg IV infusion once every 4 weeks starting at Week 52 in the OLE period. |
| Period Title: Placebo-Controlled Period | ||||
| Started | 166 | 324 | 0 | 0 |
| Treated | 165 | 321 | 0 | 0 |
| Completed [1] | 144 | 279 | 0 | 0 |
| Not Completed | 22 | 45 | 0 | 0 |
| Reason Not Completed | ||||
| Randomized but not Treated | 1 | 3 | 0 | 0 |
| Lack of Efficacy | 0 | 1 | 0 | 0 |
| Adverse Event | 16 | 21 | 0 | 0 |
| Withdrawal by Subject | 3 | 11 | 0 | 0 |
| Withdrawal by Parent/Guardian | 1 | 2 | 0 | 0 |
| Reason Not Specified | 1 | 6 | 0 | 0 |
| Death | 0 | 1 | 0 | 0 |
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[1]
Participants who completed the study PC period
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| Period Title: Open-Label Extension Period | ||||
| Started | 0 | 0 | 140 [1] | 276 [2] |
| Completed | 0 | 0 | 0 | 0 |
| Not Completed | 0 | 0 | 140 | 276 |
| Reason Not Completed | ||||
| Lack of Efficacy | 0 | 0 | 1 | 2 |
| Adverse Event | 0 | 0 | 13 | 17 |
| Withdrawal by Subject | 0 | 0 | 7 | 20 |
| Death | 0 | 0 | 0 | 1 |
| Lost to Follow-up | 0 | 0 | 1 | 0 |
| Failure to Meet Randomization Criteria | 0 | 0 | 2 | 0 |
| Withdrawal by Sponsor | 0 | 0 | 115 | 228 |
| Withdrawal by Parent/Guardian | 0 | 0 | 0 | 4 |
| Reason not Specified | 0 | 0 | 1 | 4 |
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[1]
4 participants did not enter OLE period.
[2]
3 participants did not enter OLE period.
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Baseline Characteristics
| Arm/Group Title | Placebo (PC Period) | BIIB092 2000 mg (PC Period) | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants assigned to BIIB092 matching placebo intravenous (IV) infusion once every 4 weeks for 48 weeks in double blind PC period and receive only placebo. | Participants who received at least one dose of BIIB092 2000 mg and were either assigned to BIIB092 2000 milligrams (mg) IV infusion or BIIB092 matching placebo IV infusion once every 4 weeks for 48 weeks in double blind PC period. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 165 | 321 | 486 | |
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Baseline Analysis Population Description |
Intent-to-treat (ITT) population included randomized participants who had received at least 1 dose of blinded study treatment (BIIB092 or Placebo).
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 165 participants | 321 participants | 486 participants | |
| 68.9 (6.57) | 68.7 (7.02) | 68.7 (6.86) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 165 participants | 321 participants | 486 participants | |
| Female |
74 44.8%
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136 42.4%
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210 43.2%
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| Male |
91 55.2%
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185 57.6%
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276 56.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 165 participants | 321 participants | 486 participants | |
| Hispanic or Latino |
5 3.0%
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7 2.2%
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12 2.5%
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| Not Hispanic or Latino |
117 70.9%
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242 75.4%
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359 73.9%
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| Unknown or Not Reported |
43 26.1%
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72 22.4%
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115 23.7%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Race | Number Analyzed | 165 participants | 321 participants | 486 participants |
| White |
138 83.6%
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281 87.5%
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419 86.2%
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| Black or African American |
1 0.6%
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1 0.3%
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2 0.4%
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| Asian Indian |
3 1.8%
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3 0.9%
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6 1.2%
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| Chinese |
0 0.0%
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1 0.3%
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1 0.2%
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| Japanese |
16 9.7%
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23 7.2%
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39 8.0%
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| Asian Other |
4 2.4%
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10 3.1%
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14 2.9%
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| Unknown |
3 1.8%
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2 0.6%
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5 1.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
Study got terminated as the primary endpoint was not met. PC period was completed at the time of termination. The study was not terminated due to a safety concern.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
| Name/Title: | Biogen Study Medical Director |
| Organization: | Biogen |
| Phone: | 866-633-4636 |
| EMail: | clinicaltrials@biogen.com |
| Responsible Party: | Biogen |
| ClinicalTrials.gov Identifier: | NCT03068468 |
| Other Study ID Numbers: |
251PP301 2016-002554-21 ( EudraCT Number ) CN002-012 ( Other Identifier: Briston-Myers Squibb ) |
| First Submitted: | February 27, 2017 |
| First Posted: | March 1, 2017 |
| Results First Submitted: | September 3, 2020 |
| Results First Posted: | December 21, 2020 |
| Last Update Posted: | December 21, 2020 |