PsoriasisPhase 1NCT03922607
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque Psoriasis
A Phase 1 study testing ABBV-157 in people with Psoriasis, run by AbbVie at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- ABBV-157
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 10 sitesUnited States
- Study dates
- 11 Jun 2019to 13 Apr 2021
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Anaheim Clinical Trials LLC /ID# 213645
Anaheim, California, 92801-2658
PPD PH I Clinical Unit /ID# 213062
Austin, Texas, 78744
Total Skin and Beauty Derm Ctr /ID# 222593
Birmingham, Alabama, 35205
Acpru /Id# 213639
Grayslake, Illinois, 60030
Dermatology Res. Assoc., CA /ID# 224980
Los Angeles, California, 90045
Providence Clinical Research /ID# 213339
North Hollywood, California, 91606
Alliance Dermatology and MOHs /ID# 222622
Phoenix, Arizona, 85032
University of Pittsburgh MC /ID# 224699
Pittsburgh, Pennsylvania, 15260
Advanced Medical Research /ID# 216090
Sandy Springs, Georgia, 30328-6141
Center for Clinical Studies - Webster TX /ID# 217352
Webster, Texas, 77598
About this study
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
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.
- Conditions
- Psoriasis
- Being tested
- ABBV-157, Placebo for ABBV-157
- Keywords
- Psoriasis, Chronic Plaque Psoriasis, ABBV-157, Healthy Volunteers
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-157Drug
ABBV-157 will be administered orally as capsule
Placebo for ABBV-157Drug
Placebo for ABBV-157 will be administered orally as capsule
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ABBV-157; Drug: Placebo for ABBV-157 |
| 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 Receives: Drug: ABBV-157; Drug: Placebo for ABBV-157 |
| 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 Receives: Drug: ABBV-157; Drug: Placebo for ABBV-157 |
| 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 Receives: Drug: ABBV-157; Drug: Placebo for ABBV-157 |
| 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 Receives: Drug: ABBV-157; Drug: Placebo for ABBV-157 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substudy 1: Cmax of ABBV-157
Maximum observed plasma concentration (Cmax) of ABBV-157
Measured: Up to approximately 14 days
Substudy 1: Tmax of ABBV-157
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Measured: 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.
Measured: Day 1
Substudy 1: Trough Concentration (Ctrough) of ABBV-157
Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-157
Measured: 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).
Measured: 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.
Measured: Day 14
Substudy 1: Volume of Distribution (Vβ/F)
Volume of Distribution (Vβ/F) of ABBV-157
Measured: Day 14
Substudy 1: Apparent Terminal Phase Elimination Constant (β)
Apparent Terminal phase elimination rate constant (β or Beta)
Measured: Day 14
Substudy 1: Elimination Half-Life (t1/2)
Terminal phase elimination half-life (t1/2) of ABBV-157
Measured: Day 14
Substudy 1: Fraction Excreted Unchanged in Urine (fe)
Fraction excreted unchanged in urine (fe)
Measured: Day 14
Substudy 1: Apparent Renal Clearance (CLR)
Apparent Renal Clearance (CLR) of ABBV-157
Measured: Day 14
Substudy 1: Accumulation ratio for Cmax
Accumulation ratio for Cmax
Measured: Up to approximately 14 days
Substudy 1: Accumulation Ratio for AUCtau
Accumulation Ratio for AUCtau
Measured: Up to approximately 14 days
Substudy 2: Cmax of ABBV-157
Maximum observed plasma concentration (Cmax) of ABBV-157
Measured: Up to approximately 28 days
Substudy 2: Tmax of ABBV-157
Time to maximum observed plasma concentration (Tmax) of ABBV-157
Measured: 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.
Measured: Day 1
Substudy 2: AUCtau of ABBV-157
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau)
Measured: Day 28
Substudy 2: Apparent Oral Clearance (CL/F)
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Measured: Day 28
Substudy 2: Volume of Distribution (Vβ/F)
Volume of Distribution (Vβ/F) of ABBV-157
Measured: Day 28
Substudy 2: Apparent Terminal Phase Elimination Constant (β)
Apparent Terminal phase elimination rate constant (β or Beta)
Measured: Day 28
Substudy 2: Elimination Half-Life (t1/2)
Terminal phase elimination half-life (t1/2) of ABBV-157
Measured: Day 28
Substudy 2: Accumulation ratio for Cmax
Accumulation ratio for Cmax
Measured: Up to approximately 28 days
Substudy 2: Accumulation Ratio for AUCtau
Accumulation Ratio for AUCtau
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 58
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start11 Jun 2019
- Primary completion13 Apr 2021
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922607
- Sponsor's protocol ID
- M17-238
- Status last verified
- May 2021
- First submitted
- 18 Apr 2019
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38231873