Trial Outcomes & Findings for Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis (NCT NCT03764475)

Last Updated: 2022-09-02

Results Overview

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that began after initiating study treatment (treatment-emergent AEs \[TEAEs\]) in ARQ-151-202 are presented.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

332 participants

Primary outcome timeframe

Up to 52 weeks

Results posted on

2022-09-02

Participant Flow

Participants were recruited at 30 study sites in the United States and Canada.

Participant milestones

Participant milestones
Measure	Cohort 1: Study 201 Participants This arm consisted of participants who previously participated in Study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.	Cohort 2: Non-study 201 Participants This arm consisted of participants who did not previously participate in Study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring.
Overall Study STARTED	230	102
Overall Study COMPLETED	164	80
Overall Study NOT COMPLETED	66	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Study 201 Participants This arm consisted of participants who previously participated in Study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.	Cohort 2: Non-study 201 Participants This arm consisted of participants who did not previously participate in Study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring.
Overall Study Adverse Event	11	2
Overall Study Lost to Follow-up	24	10
Overall Study Withdrawal by Subject	26	10
Overall Study Lack of Efficacy	3	0
Overall Study COVID-19 Disruption	2	0

Baseline Characteristics

One participant in Cohort 2 did not have a baseline mPASI assessment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Study 201 Participants n=230 Participants This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.	Cohort 2: Non-study 201 Participants n=102 Participants This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring.	Total n=332 Participants Total of all reporting groups
Age, Continuous	55.3 years STANDARD_DEVIATION 13.52 • n=230 Participants	52.7 years STANDARD_DEVIATION 15.64 • n=102 Participants	54.5 years STANDARD_DEVIATION 14.23 • n=332 Participants
Sex: Female, Male Female	104 Participants n=230 Participants	46 Participants n=102 Participants	150 Participants n=332 Participants
Sex: Female, Male Male	126 Participants n=230 Participants	56 Participants n=102 Participants	182 Participants n=332 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants n=230 Participants	17 Participants n=102 Participants	63 Participants n=332 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	184 Participants n=230 Participants	84 Participants n=102 Participants	268 Participants n=332 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=230 Participants	1 Participants n=102 Participants	1 Participants n=332 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=230 Participants	0 Participants n=102 Participants	0 Participants n=332 Participants
Race/Ethnicity, Customized Asian	13 Participants n=230 Participants	6 Participants n=102 Participants	19 Participants n=332 Participants
Race/Ethnicity, Customized Black or African American	24 Participants n=230 Participants	5 Participants n=102 Participants	29 Participants n=332 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=230 Participants	1 Participants n=102 Participants	1 Participants n=332 Participants
Race/Ethnicity, Customized White	183 Participants n=230 Participants	85 Participants n=102 Participants	268 Participants n=332 Participants
Race/Ethnicity, Customized Multiple/Other	10 Participants n=230 Participants	5 Participants n=102 Participants	15 Participants n=332 Participants
Modified Psoriasis Area Severity Index (mPASI)	5.42 score on a scale STANDARD_DEVIATION 3.700 • n=230 Participants • One participant in Cohort 2 did not have a baseline mPASI assessment.	4.50 score on a scale STANDARD_DEVIATION 3.821 • n=101 Participants • One participant in Cohort 2 did not have a baseline mPASI assessment.	5.14 score on a scale STANDARD_DEVIATION 3.755 • n=331 Participants • One participant in Cohort 2 did not have a baseline mPASI assessment.

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: All randomized participants who received ≥1 dose of study treatment are included.

Outcome measures

Outcome measures
Measure	Cohort 1: Study 201 Participants n=230 Participants This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.	Cohort 2: Non-study 201 Participants n=102 Participants This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled after the time of amendment 1 in this study. Participants applied roflumilast cream 0.3% once daily for 52 weeks to monitor long-term safety.
Number of Participants Experiencing ≥1 Treatment-emergent Adverse Event (TEAE)	104 Participants	60 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: All randomized participants who received ≥1 dose of study drug are included.

An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following outcomes: Death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Cohort 1: Study 201 Participants n=230 Participants This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.	Cohort 2: Non-study 201 Participants n=102 Participants This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled after the time of amendment 1 in this study. Participants applied roflumilast cream 0.3% once daily for 52 weeks to monitor long-term safety.
Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)	8 Participants	2 Participants

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, and 52

Population: All participants who received ≥1 dose of study drug and have data available at the relevant time points are included.

The number of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 12 is reported. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity.

Outcome measures

Outcome measures
Measure	Cohort 1: Study 201 Participants n=209 Participants This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.	Cohort 2: Non-study 201 Participants n=95 Participants This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled after the time of amendment 1 in this study. Participants applied roflumilast cream 0.3% once daily for 52 weeks to monitor long-term safety.
Number of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Week 12	92 Participants	47 Participants
Number of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Week 24	79 Participants	34 Participants
Number of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Week 36	68 Participants	36 Participants
Number of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Week 52	68 Participants	39 Participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: All participants who received ≥1 dose of study drug and achieved an IGA score of 'clear' are included.

The median time to re-starting study therapy among participants who achieve a 'clear' IGA score and stop treatment to all lesions is presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Study 201 Participants n=23 Participants This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.	Cohort 2: Non-study 201 Participants n=6 Participants This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled after the time of amendment 1 in this study. Participants applied roflumilast cream 0.3% once daily for 52 weeks to monitor long-term safety.
Duration of Response in Participants Achieving 'Clear' IGA Score	8.0 weeks Interval 4.1 to 9.0	12.4 weeks Interval 3.0 to Upper bound of the 95% CI was not estimable due to low number of cases.

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, and 52

Population: All participants who received ≥1 dose of study drug, have intertriginous area involvement, and have data available at the relevant time points are included. This endpoint was added at protocol amendment 1, and thus I-IGA was not assessed in a subset of participants in Cohort 1.

The number of participants who had intertriginous area involvement with an I-IGA score of 'clear' or 'almost clear' is presented. The I-IGA is 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity.

Outcome measures

Outcome measures
Measure	Cohort 1: Study 201 Participants n=38 Participants This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.	Cohort 2: Non-study 201 Participants n=26 Participants This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled after the time of amendment 1 in this study. Participants applied roflumilast cream 0.3% once daily for 52 weeks to monitor long-term safety.
Number of Participants With Intertriginous Area Involvement Achieving an Intertriginous Area Investigator Global Assessment (I-IGA) Score of "Clear' or 'Almost Clear' Week 12	11 Participants	15 Participants
Number of Participants With Intertriginous Area Involvement Achieving an Intertriginous Area Investigator Global Assessment (I-IGA) Score of "Clear' or 'Almost Clear' Week 24	13 Participants	14 Participants
Number of Participants With Intertriginous Area Involvement Achieving an Intertriginous Area Investigator Global Assessment (I-IGA) Score of "Clear' or 'Almost Clear' Week 36	13 Participants	10 Participants
Number of Participants With Intertriginous Area Involvement Achieving an Intertriginous Area Investigator Global Assessment (I-IGA) Score of "Clear' or 'Almost Clear' Week 52	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, and 52

Population: All participants who received ≥1 dose of study drug and have data available at the relevant time points are included. This endpoint was added at protocol amendment 1, and thus mPASI was not assessed in a subset of participants in Cohort 1.

The number of participants achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity.

Outcome measures

Outcome measures
Measure	Cohort 1: Study 201 Participants n=230 Participants This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.	Cohort 2: Non-study 201 Participants n=102 Participants This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled after the time of amendment 1 in this study. Participants applied roflumilast cream 0.3% once daily for 52 weeks to monitor long-term safety.
Number of Participants Achieving a 75% Reduction From Baseline in Modified Psoriasis Severity Index (mPASI-75) Week 12	67 Participants	63 Participants
Number of Participants Achieving a 75% Reduction From Baseline in Modified Psoriasis Severity Index (mPASI-75) Week 24	114 Participants	57 Participants
Number of Participants Achieving a 75% Reduction From Baseline in Modified Psoriasis Severity Index (mPASI-75) Week 36	130 Participants	55 Participants
Number of Participants Achieving a 75% Reduction From Baseline in Modified Psoriasis Severity Index (mPASI-75) Week 52	124 Participants	61 Participants

Adverse Events

Cohort 1: Study 201 Participants

Serious events: 8 serious events

Other events: 15 other events

Deaths: 0 deaths

Cohort 2: Non-study 201 Participants

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Cohort 1: Study 201 Participants n=230 participants at risk This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.	Cohort 2: Non-study 201 Participants n=102 participants at risk This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring.
Infections and infestations Upper respiratory tract infection	6.5% 15/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	6.9% 7/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.

Additional Information

Arcutis Medical Information

Arcutis Biotherapeutics

Phone: +1 (844) 692-6729

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor is supportive of publishing clinical trial findings. The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort 1: Study 201 Participants n=230 participants at risk This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.	Cohort 2: Non-study 201 Participants n=102 participants at risk This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring.
Cardiac disorders Atrioventricular block complete	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Cardiac disorders Cardiac failure congestive	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Cardiac disorders Myocardial infarction	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Cardiac disorders Supraventricular tachycardia	0.00% 0/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.98% 1/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Gastrointestinal disorders Ileus	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Infections and infestations Sepsis	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Injury, poisoning and procedural complications Femur fracture	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Investigations SARS-CoV-2 test positive	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Metabolism and nutrition disorders Hyponatraemia	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Nervous system disorders Cerebrovascular accident	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Nervous system disorders Transient ischaemic attack	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Product Issues Device failure	0.00% 0/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.98% 1/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Psychiatric disorders Alcohol withdrawal syndrome	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Renal and urinary disorders Acute kidney injury	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.
Renal and urinary disorders Urinary retention	0.43% 1/230 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.	0.00% 0/102 • Up to 52 weeks All participants who received ≥1 dose of study drug are included.