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This is a study to evaluate pharmacokinetics (PK), safety and tolerability of ABBV-157 in healthy volunteers and in participants with chronic plaque psoriasis, and to evaluate the efficacy of ABBV-157 in the participants with psoriasis. This study consists of two substudies. Substudy 1 is a randomized, double-blind, placebo-controlled evaluation of multiple ascending oral doses of ABBV-157 in healthy adult volunteers. Substudy 2 is a randomized, double-blind, placebo-controlled study in which participants with moderate to severe chronic plaque psoriasis will be administered multiple oral doses of ABBV-157.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substudy 2: Group 2 | Experimental | Participants with chronic plaque psoriasis will be administered with ABBV-157 dose D or matching placebo on Day 1 through Day 28 |
|
| Substudy 2: Group 1 | Experimental | Participants with chronic plaque psoriasis will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 28 |
|
| Substudy 1: Group 3 | Experimental | Participants, who are healthy volunteers, will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 14 |
|
| Substudy 1: Group 2 | Experimental | Participants, who are healthy volunteers, will be administered with ABBV-157 dose B or matching placebo on Day 1 through Day 14 |
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| Substudy 1: Group 1 | Experimental | Participants, who are healthy volunteers, will be administered with ABBV-157 dose A or matching placebo on Day 1 through Day 14 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-157 | Drug | ABBV-157 will be administered orally as capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Substudy 1: Cmax of ABBV-157 | Maximum observed plasma concentration (Cmax) of ABBV-157 | Up to approximately 14 days |
| Substudy 1: Tmax of ABBV-157 | Time to maximum observed plasma concentration (Tmax) of ABBV-157 | Up to approximately 14 days |
| Substudy 1: AUC0-24 Post-dose of ABBV-157 | Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157. | Day 1 |
| Substudy 1: Trough Concentration (Ctrough) of ABBV-157 | Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157 | Up to approximately 14 days |
| Substudy 1: AUCtau of ABBV-157 | The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau). | Up to approximately 14 days |
| Substudy 1: Apparent Oral Clearance (CL/F) | Clearance is defined as the volume of plasma cleared of the drug per unit time. | Day 14 |
| Substudy 1: Volume of Distribution (Vβ/F) | Volume of Distribution (Vβ/F) of ABBV-157 | Day 14 |
| Substudy 1: Apparent Terminal Phase Elimination Constant (β) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Derm Ctr /ID# 222593 | Birmingham | Alabama | 35205 | United States | ||
| Alliance Dermatology and MOHs /ID# 222622 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38231873 | Derived | Maier CS, Eckert D, Laroux FS, Hew KM, Suleiman AA, Liu W, Mohamed MF. Cedirogant Population Pharmacokinetics and Pharmacodynamic Analyses of Interleukin-17A Inhibition in Two Phase 1 Studies in Healthy Participants and Participants with Moderate to Severe Psoriasis. Clin Pharmacol Drug Dev. 2024 May;13(5):474-484. doi: 10.1002/cpdd.1377. Epub 2024 Jan 17. |
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|
| Placebo for ABBV-157 | Drug | Placebo for ABBV-157 will be administered orally as capsule |
|
Apparent Terminal phase elimination rate constant (β or Beta) |
| Day 14 |
| Substudy 1: Elimination Half-Life (t1/2) | Terminal phase elimination half-life (t1/2) of ABBV-157 | Day 14 |
| Substudy 1: Fraction Excreted Unchanged in Urine (fe) | Fraction excreted unchanged in urine (fe) | Day 14 |
| Substudy 1: Apparent Renal Clearance (CLR) | Apparent Renal Clearance (CLR) of ABBV-157 | Day 14 |
| Substudy 1: Accumulation ratio for Cmax | Accumulation ratio for Cmax | Up to approximately 14 days |
| Substudy 1: Accumulation Ratio for AUCtau | Accumulation Ratio for AUCtau | Up to approximately 14 days |
| Substudy 2: Cmax of ABBV-157 | Maximum observed plasma concentration (Cmax) of ABBV-157 | Up to approximately 28 days |
| Substudy 2: Tmax of ABBV-157 | Time to maximum observed plasma concentration (Tmax) of ABBV-157 | Up to approximately 28 days |
| Substudy 2: AUC0-24 Post-dose of ABBV-157 | Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157. | Day 1 |
| Substudy 2: AUCtau of ABBV-157 | The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau) | Day 28 |
| Substudy 2: Apparent Oral Clearance (CL/F) | Clearance is defined as the volume of plasma cleared of the drug per unit time. | Day 28 |
| Substudy 2: Volume of Distribution (Vβ/F) | Volume of Distribution (Vβ/F) of ABBV-157 | Day 28 |
| Substudy 2: Apparent Terminal Phase Elimination Constant (β) | Apparent Terminal phase elimination rate constant (β or Beta) | Day 28 |
| Substudy 2: Elimination Half-Life (t1/2) | Terminal phase elimination half-life (t1/2) of ABBV-157 | Day 28 |
| Substudy 2: Accumulation ratio for Cmax | Accumulation ratio for Cmax | Up to approximately 28 days |
| Substudy 2: Accumulation Ratio for AUCtau | Accumulation Ratio for AUCtau | Up to approximately 28 days |
| Substudy 2: Trough Concentration (Ctrough) of ABBV-157 | Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157 | Up to approximately 28 days |
| Substudy 2: Percent Change in Psoriasis Area and Severity Index (PASI) score from Baseline | Psoriasis Area and Severity Index (PASI) score quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity. | Up to approximately 28 days |
| Substudy 2: Change in Self-Assessment of Psoriasis Symptoms (SAPS) Score from Baseline | SAPS is a self-assessment questionnaire of psoriasis symptoms. | Up to approximately 28 days |
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. | Up to Day 58 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Anaheim Clinical Trials LLC /ID# 213645 | Anaheim | California | 92801-2658 | United States |
| Dermatology Res. Assoc., CA /ID# 224980 | Los Angeles | California | 90045 | United States |
| Providence Clinical Research /ID# 213339 | North Hollywood | California | 91606 | United States |
| Advanced Medical Research /ID# 216090 | Sandy Springs | Georgia | 30328-6141 | United States |
| Acpru /Id# 213639 | Grayslake | Illinois | 60030 | United States |
| University of Pittsburgh MC /ID# 224699 | Pittsburgh | Pennsylvania | 15260 | United States |
| PPD PH I Clinical Unit /ID# 213062 | Austin | Texas | 78744 | United States |
| Center for Clinical Studies - Webster TX /ID# 217352 | Webster | Texas | 77598 | United States |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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