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ABBV-157

Phase 1

Psoriasis | Small molecule | Dermatology |AbbVie Inc.|Last Updated: May 11, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-157 · 1 trial · 1 indication

Phase 1 1
NCT03922607A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque PsoriasisPsoriasis
COMPLETED65 Analytics
PHASE1COMPLETED
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Maximum observed plasma concentration (Cmax) of ABBV-157

Substudy 1: Tmax of ABBV-157
Up to approximately 14 days

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

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.

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

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).

Substudy 1: Apparent Oral Clearance (CL/F)
Day 14

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

Substudy 1: Volume of Distribution (Vβ/F)
Day 14

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

Substudy 1: Apparent Terminal Phase Elimination Constant (β)
Day 14

Apparent Terminal phase elimination rate constant (β or Beta)

Substudy 1: Elimination Half-Life (t1/2)
Day 14

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

Substudy 1: Fraction Excreted Unchanged in Urine (fe)
Day 14

Fraction excreted unchanged in urine (fe)

Substudy 1: Apparent Renal Clearance (CLR)
Day 14

Apparent Renal Clearance (CLR) of ABBV-157

Substudy 1: Accumulation ratio for Cmax
Up to approximately 14 days

Accumulation ratio for Cmax

Substudy 1: Accumulation Ratio for AUCtau
Up to approximately 14 days

Accumulation Ratio for AUCtau

Substudy 2: Cmax of ABBV-157
Up to approximately 28 days

Maximum observed plasma concentration (Cmax) of ABBV-157

Substudy 2: Tmax of ABBV-157
Up to approximately 28 days

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

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.

Substudy 2: AUCtau of ABBV-157
Day 28

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

Substudy 2: Apparent Oral Clearance (CL/F)
Day 28

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

Substudy 2: Volume of Distribution (Vβ/F)
Day 28

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

Substudy 2: Apparent Terminal Phase Elimination Constant (β)
Day 28

Apparent Terminal phase elimination rate constant (β or Beta)

Substudy 2: Elimination Half-Life (t1/2)
Day 28

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

Substudy 2: Accumulation ratio for Cmax
Up to approximately 28 days

Accumulation ratio for Cmax

Substudy 2: Accumulation Ratio for AUCtau
Up to approximately 28 days

Accumulation Ratio for AUCtau

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

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.

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.

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.

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Substudy 2: Group 2EXPERIMENTALParticipants with chronic plaque psoriasis will be administered with ABBV-157 dose D or matching placebo on Day 1 through Day 28
Substudy 2: Group 1EXPERIMENTALParticipants with chronic plaque psoriasis will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 28
Substudy 1: Group 3EXPERIMENTALParticipants, who are healthy volunteers, will be administered with ABBV-157 dose C or matching placebo on Day 1 through Day 14
Substudy 1: Group 2EXPERIMENTALParticipants, who are healthy volunteers, will be administered with ABBV-157 dose B or matching placebo on Day 1 through Day 14
Substudy 1: Group 1EXPERIMENTALParticipants, who are healthy volunteers, will be administered with ABBV-157 dose A or matching placebo on Day 1 through Day 14

Interventions

NameTypeDescription
ABBV-157DRUGABBV-157 will be administered orally as capsule
Placebo for ABBV-157DRUGPlacebo for ABBV-157 will be administered orally as capsule
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites10

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 asses...

Countries:United States
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Frequently asked questions about ABBV-157

What is ABBV-157 used for?

ABBV-157 is an investigational small molecule being developed for the treatment of psoriasis, a chronic skin condition. It is currently in Phase 1 clinical development and has been studied in healthy volunteers and in participants with chronic plaque psoriasis.

What does ABBV-157 target?

The molecular target of ABBV-157 has not been disclosed. It is a small molecule being studied for its pharmacokinetics, safety, and tolerability in the treatment of psoriasis.

Who makes ABBV-157?

ABBV-157 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV.

What phase is ABBV-157 in?

ABBV-157 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is ABBV-157 in?

ABBV-157 has been studied in one completed Phase 1 trial, NCT03922607, which evaluated its pharmacokinetics, safety, and tolerability in healthy volunteers and participants with chronic plaque psoriasis. The trial enrolled 65 participants in the United States.

Is ABBV-157 the same as any other drug?

No alternative names for ABBV-157 have been disclosed. It is identified solely by its development code ABBV-157.