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The purpose of this study is to assess how safe, effective, and tolerable ABBV-547 is in adult participants in the United States and Japan.
There will be 2 parts to this study. In Part 1, participants are placed in one of 7 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 4 chance participants will receive placebo. In Part 2, participants are placed in one of 3 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 7 chance participants will receive placebo. Approximately 121 adult participants will be enrolled at approximately 21 sites in the United States and Japan.
Participants will be administered one dose of ABBV-547 or placebo.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: ABBV-547 & Placebo | Experimental | Participants will receive either ABBV-547 or placebo. |
|
| Group 2: ABBV-547 & Placebo | Experimental | Participants will receive either ABBV-547 or placebo. |
|
| Group 3: ABBV-547 & Placebo | Experimental | Participants will receive either ABBV-547 or placebo. |
|
| Group 4: ABBV-547 & Placebo | Experimental | Participants will receive either ABBV-547 or placebo. |
|
| Group 5: ABBV-547 & Placebo | Experimental | Participants will receive either ABBV-547 or placebo. |
|
| Group 6: ABBV-547 & Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-547 | Drug | Parental Administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to Approximately Day 365 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Dermatology /ID# 279798 | Recruiting | Birmingham | Alabama | 35203-4024 | United States | |
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Participants will receive either ABBV-547 or placebo. |
|
| Group 7: ABBV-547 & Placebo | Experimental | Participants will receive either ABBV-547 or placebo. |
|
| Group 8: ABBV-547 & Placebo | Experimental | Japanese participants will receive either ABBV-547 or placebo. |
|
| Group 9: ABBV-547 & Placebo | Experimental | Han Chinese participants will receive either ABBV-547 or placebo. |
|
| Group 10: ABBV-547 & Placebo | Experimental | Participants will receive either ABBV-547 or placebo. |
|
| ABBV-547 Placebo | Drug | Parental Administration |
|
| Dermatology Trial Associates /ID# 279984 |
| Recruiting |
| Bryant |
| Arkansas |
| 72022 |
| United States |
| Cenexel act- Anaheim Clinical Trials /ID# 279612 | Recruiting | Anaheim | California | 92801 | United States |
| Dermatology Research Associates - Los Angeles /ID# 279383 | Recruiting | Los Angeles | California | 90045 | United States |
| Integrative Skin Science and Research - Location 2 /ID# 279386 | Recruiting | Sacramento | California | 95815 | United States |
| Skin Care Research Boca Raton /ID# 279988 | Not yet recruiting | Boca Raton | Florida | 33486-2269 | United States |
| Wellness Clinical Research - Miami Lakes /ID# 279803 | Recruiting | Miami Lakes | Florida | 33016 | United States |
| Advanced Clinical Research Institute - Tampa /ID# 279342 | Recruiting | Tampa | Florida | 33607 | United States |
| Trueblue Clinical Research - Tampa /ID# 281757 | Not yet recruiting | Tampa | Florida | 33609 | United States |
| University Dermatology & Vein Clinic - Darien /ID# 279986 | Not yet recruiting | Darien | Illinois | 60561 | United States |
| Acpru /Id# 278638 | Recruiting | Grayslake | Illinois | 60030 | United States |
| MetroBoston Clinical Partners /ID# 279992 | Recruiting | Boston | Massachusetts | 02135 | United States |
| Minnesota Clinical Study Center /ID# 279987 | Recruiting | New Brighton | Minnesota | 55112 | United States |
| MediSearch Clinical Trials /ID# 279416 | Recruiting | Saint Joseph | Missouri | 64506 | United States |
| Skin Specialists /ID# 279531 | Recruiting | Omaha | Nebraska | 68144 | United States |
| The Skin Center Dermatology Group /ID# 279983 | Recruiting | New City | New York | 10956-7153 | United States |
| Equity Medical, LLC - Bronx /ID# 279808 | Recruiting | The Bronx | New York | 10455 | United States |
| Oregon Dermatology & Research Center /ID# 279391 | Recruiting | Portland | Oregon | 97210 | United States |
| Health Concepts /ID# 279529 | Recruiting | Rapid City | South Dakota | 57702 | United States |
| Center for Clinical Studies - Houston - Binz Street /ID# 279419 | Recruiting | Houston | Texas | 77004 | United States |
| Austin Institute for Clinical Research - Pflugerville /ID# 279387 | Recruiting | Pflugerville | Texas | 78660 | United States |
| University of the Ryukyus Hospital /ID# 279918 | Recruiting | Ginowan-shi | Okinawa | 901-2725 | Japan |
| Fukuoka University Hospital /ID# 279530 | Recruiting | Fukuoka | 814-0180 | Japan |