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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006946-24 | EudraCT Number |
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This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15. |
|
| RO5217790 | Experimental | RO5217790 will be administered at a dose of 5*10^7 plaque forming unit (pfu) subcutaneously on Days 1, 8, and 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with CIN2/CIN3 associated with HPV16 single infection who achieved Histologic resolution (Defined as no CIN), determined by evaluation of tissue derived from surgical excision | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who achieved Histologic resolution (Defined as no CIN), determined by evaluation of tissue derived from surgical excision | Months 6 | |
| Percentage of participants who achieved Histologic response (Defined as CIN Grade less than [<] 2), determined by evaluation of tissue derived from surgical excision |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608 | United States | |||
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| RO5217790 | Drug | RO5217790 will be administered at a dose of 5*10^7 pfu subcutaneously on Days 1, 8, and 15. |
|
| Month 6 |
| Percentage of participants with viral clearance based on Roche Linear assay results | Months 3 and 6 |
| Percentage of participants with immunologic response to HPV antigens | Day 1 (predose), Days 8, 15, and 29, Months 3 and 6 |
| Percentage of Participants with at least one Adverse Events (AEs) | Up to Month 30 |
| Phoenix |
| Arizona |
| 85015 |
| United States |
| Phoenix | Arizona | 85032 | United States |
| Tucson | Arizona | 85712 | United States |
| Tucson | Arizona | 85724-5078 | United States |
| Colton | California | 92324 | United States |
| Los Angeles | California | 90027 | United States |
| Colorado Springs | Colorado | 80910 | United States |
| Stamford | Connecticut | 06904 | United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| Lake Worth | Florida | 33461 | United States |
| Miami | Florida | 33136 | United States |
| Plantation | Florida | 33324 | United States |
| Sarasota | Florida | 34239 | United States |
| South Miami | Florida | 33143 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Atlanta | Georgia | 30322 | United States |
| Augusta | Georgia | 30912 | United States |
| Decatur | Georgia | 30034 | United States |
| Marrero | Louisiana | 70072 | United States |
| Framingham | Massachusetts | 01702 | United States |
| Kansas City | Missouri | 64139 | United States |
| Lincoln | Nebraska | 68510 | United States |
| Las Vegas | Nevada | 89030 | United States |
| Las Vegas | Nevada | 89128 | United States |
| Lawrenceville | New Jersey | 08648 | United States |
| Brightwaters | New York | 11718 | United States |
| The Bronx | New York | 10461 | United States |
| New Bern | North Carolina | 28562 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Englewood | Ohio | 45322 | United States |
| Gallipolis | Ohio | 45631 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| West Reading | Pennsylvania | 19611 | United States |
| Columbia | South Carolina | 29201 | United States |
| Greenville | South Carolina | 29615 | United States |
| Myrtle Beach | South Carolina | 29572 | United States |
| Nashville | Tennessee | 37232 | United States |
| Austin | Texas | 78705 | United States |
| Houston | Texas | 77004 | United States |
| McAllen | Texas | 78503 | United States |
| Sandy City | Utah | 84070 | United States |
| Norfolk | Virginia | 23502 | United States |
| Antwerp | 2020 | Belgium |
| Brussels | 1070 | Belgium |
| Brussels | 1090 | Belgium |
| Edegem | 2650 | Belgium |
| Ghent | 9000 | Belgium |
| Leuven | 3000 | Belgium |
| Tienen | 3300 | Belgium |
| Hus | 00029 | Finland |
| Kuopio | 70211 | Finland |
| Oulu | 90220 | Finland |
| Tampere | 33520 | Finland |
| Bordeaux | 33076 | France |
| Dijon | 21079 | France |
| Nantes | 44093 | France |
| Paris | 75231 | France |
| Reims | 51092 | France |
| Strasbourg | 67098 | France |
| San Juan | 00909-1711 | Puerto Rico |
| San Juan | 00935 | Puerto Rico |
| Barcelona | Barcelona | 08036 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28942 | Spain |
| Bilbao | Vizcaya | 48013 | Spain |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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