A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque Psoriasis

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03922607
• Collaborator: (none)
• Enrollment: 65
• Locations: 10
• Arms: 5
• Actual Duration (Months): 22.1
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: ABBV-157; Drug: Placebo for ABBV-157	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Subjects With Chronic Plaque Psoriasis
• Actual Study Start Date: Jun 11, 2019
• Actual Primary Completion Date: Apr 13, 2021
• Actual Study Completion Date: Apr 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Substudy 2: Group 2 Participants with chronic plaque psoriasis will be administered with ABBV-157 dose D or matching placebo on Day 1 through Day 28	Drug: ABBV-157; ABBV-157 will be administered orally as capsule; Drug: Placebo for ABBV-157; Placebo for ABBV-157 will be administered orally as capsule
Experimental: Substudy 2: Group 1 Participants with chronic plaque psoriasis will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 28	Drug: ABBV-157; ABBV-157 will be administered orally as capsule; Drug: Placebo for ABBV-157; Placebo for ABBV-157 will be administered orally as capsule
Experimental: Substudy 1: Group 3 Participants, who are healthy volunteers, will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 14	Drug: ABBV-157; ABBV-157 will be administered orally as capsule; Drug: Placebo for ABBV-157; Placebo for ABBV-157 will be administered orally as capsule
Experimental: Substudy 1: Group 2 Participants, who are healthy volunteers, will be administered with ABBV-157 dose B or matching placebo on Day 1 through Day 14	Drug: ABBV-157; ABBV-157 will be administered orally as capsule; Drug: Placebo for ABBV-157; Placebo for ABBV-157 will be administered orally as capsule
Experimental: Substudy 1: Group 1 Participants, who are healthy volunteers, will be administered with ABBV-157 dose A or matching placebo on Day 1 through Day 14	Drug: ABBV-157; ABBV-157 will be administered orally as capsule; Drug: Placebo for ABBV-157; Placebo for ABBV-157 will be administered orally as capsule

Outcome Measures

Primary Outcome Measures

1. Substudy 1: Cmax of ABBV-157 [Up to approximately 14 days]

   Maximum observed plasma concentration (Cmax) of ABBV-157

2. Substudy 1: Tmax of ABBV-157 [Up to approximately 14 days]

   Time to maximum observed plasma concentration (Tmax) of ABBV-157

3. Substudy 1: AUC0-24 Post-dose of ABBV-157 [Day 1]

   Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157.

4. Substudy 1: Trough Concentration (Ctrough) of ABBV-157 [Up to approximately 14 days]

   Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157

5. Substudy 1: AUCtau of ABBV-157 [Up to approximately 14 days]

   The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau).

6. Substudy 1: Apparent Oral Clearance (CL/F) [Day 14]

   Clearance is defined as the volume of plasma cleared of the drug per unit time.

7. Substudy 1: Volume of Distribution (Vβ/F) [Day 14]

   Volume of Distribution (Vβ/F) of ABBV-157

8. Substudy 1: Apparent Terminal Phase Elimination Constant (β) [Day 14]

   Apparent Terminal phase elimination rate constant (β or Beta)

9. Substudy 1: Elimination Half-Life (t1/2) [Day 14]

   Terminal phase elimination half-life (t1/2) of ABBV-157

10. Substudy 1: Fraction Excreted Unchanged in Urine (fe) [Day 14]

    Fraction excreted unchanged in urine (fe)

11. Substudy 1: Apparent Renal Clearance (CLR) [Day 14]

    Apparent Renal Clearance (CLR) of ABBV-157

12. Substudy 1: Accumulation ratio for Cmax [Up to approximately 14 days]

    Accumulation ratio for Cmax

13. Substudy 1: Accumulation Ratio for AUCtau [Up to approximately 14 days]

    Accumulation Ratio for AUCtau

14. Substudy 2: Cmax of ABBV-157 [Up to approximately 28 days]

    Maximum observed plasma concentration (Cmax) of ABBV-157

15. Substudy 2: Tmax of ABBV-157 [Up to approximately 28 days]

    Time to maximum observed plasma concentration (Tmax) of ABBV-157

16. Substudy 2: AUC0-24 Post-dose of ABBV-157 [Day 1]

    Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of ABBV-157.

17. Substudy 2: AUCtau of ABBV-157 [Day 28]

    The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)

18. Substudy 2: Apparent Oral Clearance (CL/F) [Day 28]

    Clearance is defined as the volume of plasma cleared of the drug per unit time.

19. Substudy 2: Volume of Distribution (Vβ/F) [Day 28]

    Volume of Distribution (Vβ/F) of ABBV-157

20. Substudy 2: Apparent Terminal Phase Elimination Constant (β) [Day 28]

    Apparent Terminal phase elimination rate constant (β or Beta)

21. Substudy 2: Elimination Half-Life (t1/2) [Day 28]

    Terminal phase elimination half-life (t1/2) of ABBV-157

22. Substudy 2: Accumulation ratio for Cmax [Up to approximately 28 days]

    Accumulation ratio for Cmax

23. Substudy 2: Accumulation Ratio for AUCtau [Up to approximately 28 days]

    Accumulation Ratio for AUCtau

24. Substudy 2: Trough Concentration (Ctrough) of ABBV-157 [Up to approximately 28 days]

    Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157

25. Substudy 2: Percent Change in Psoriasis Area and Severity Index (PASI) score from Baseline [Up to approximately 28 days]

    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.

26. Substudy 2: Change in Self-Assessment of Psoriasis Symptoms (SAPS) Score from Baseline [Up to approximately 28 days]

    SAPS is a self-assessment questionnaire of psoriasis symptoms.

27. Number of Participants With Adverse Events (AEs) [Up to Day 58]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Volunteer should be between 18 and 55 years of age and in general good health for Substudy 1 and participant with moderate to severe chronic plaque psoriasis between 18 and 75 years of age for Substudy 2 at the time of enrollment.

• Participant should meet the laboratory assessments as mentioned in the protocol.

Exclusion Criteria:

• Participant has a history of epilepsy, any significant cardiac, respiratory, renal, hepatic, gastrointestinal, opthalmologic, hematologic,or psychiatric disease or disorder, or any uncontrolled medical illness.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Total Skin and Beauty Derm Ctr /ID# 222593	Birmingham	Alabama	United States	35205
2	Alliance Dermatology and MOHs /ID# 222622	Phoenix	Arizona	United States	85032
3	Anaheim Clinical Trials LLC /ID# 213645	Anaheim	California	United States	92801-2658
4	Dermatology Res. Assoc., CA /ID# 224980	Los Angeles	California	United States	90045
5	Providence Clinical Research /ID# 213339	North Hollywood	California	United States	91606
6	Advanced Medical Research /ID# 216090	Sandy Springs	Georgia	United States	30328-6141
7	Acpru /Id# 213639	Grayslake	Illinois	United States	60030
8	University of Pittsburgh MC /ID# 224699	Pittsburgh	Pennsylvania	United States	15260
9	PPD PH I Clinical Unit /ID# 213062	Austin	Texas	United States	78744
10	Center for Clinical Studies - Webster TX /ID# 217352	Webster	Texas	United States	77598

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT03922607
• Other Study ID Numbers: M17-238
• First Posted: Apr 22, 2019
• Last Update Posted: May 11, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by AbbVie: Psoriasis; Chronic Plaque Psoriasis; ABBV-157; Healthy Volunteers
• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of May 11, 2021