Trial Outcomes & Findings for Apremilast 30 mg Twice Daily (BID) Combined With Dupilumab (NCT NCT04306965)

NCT ID: NCT04306965

Last Updated: 2024-04-19

Results Overview

Clinical improvement in a patient's eczematous lesions corresponds with a decrease in IGA, and a score of 0 (clear) or 1 (almost clear) is considered a significant clinical response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

week 16

Results posted on

2024-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	Apremilast Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability. Apremilast: 30 mg BID
Overall Study STARTED	10
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Apremilast 30 mg Twice Daily (BID) Combined With Dupilumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apremilast n=10 Participants Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability. Apremilast: 30 mg BID
Age, Continuous	42 years STANDARD_DEVIATION 21.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
weight in kg	86.38 kilograms STANDARD_DEVIATION 19.0 • n=5 Participants
concomitant topical steroid use	4 Participants n=5 Participants
time on dupilumab therapy	20.3 months STANDARD_DEVIATION 14.3 • n=5 Participants
% patients with asthma	8 Participants n=5 Participants
% patients with allergic rhinitis	8 Participants n=5 Participants
% patients with food allergy	6 Participants n=5 Participants
mean duration of atopic dermatitis	18.6 years STANDARD_DEVIATION 10.2 • n=5 Participants
prior atopic dermatitis treatments , % topical corticosteroids	10 Participants n=5 Participants
prior atopic dermatitis treatments , % topical calcineurin inhibitor	7 Participants n=5 Participants
prior atopic dermatitis treatments , % immunosuppressants	7 Participants n=5 Participants
prior atopic dermatitis treatments , % phototherapy	1 Participants n=5 Participants
prior atopic dermatitis treatments , % prednisone	6 Participants n=5 Participants
prior atopic dermatitis treatments , % topical phosphodiesterase-4 inhibitor	5 Participants n=5 Participants
Investigator Global Assessment Score IGA score 2 (Mild)	3 Participants n=5 Participants
Investigator Global Assessment Score IGA score 3 (Moderate)	7 Participants n=5 Participants
baseline Body Surface Area (BSA), %	9.99 % percentage of body surface area STANDARD_DEVIATION 6.3 • n=5 Participants
Baseline Dermatology Life Quality Index (DLQI)	7.6 score on a scale STANDARD_DEVIATION 5.4 • n=5 Participants
Baseline Numerical Rating Scale (NRS) pruritus	5.0 score on a scale STANDARD_DEVIATION 2.4 • n=5 Participants
Baseline Eczema Area and Severity Index (EASI)	7.4 score on a scale STANDARD_DEVIATION 3.2 • n=5 Participants

PRIMARY outcome

Timeframe: week 16

Population: An intention-to-treat analysis was performed using last observation carried forward and included all enrolled patients who received apremilast at Week 0.

Clinical improvement in a patient's eczematous lesions corresponds with a decrease in IGA, and a score of 0 (clear) or 1 (almost clear) is considered a significant clinical response.

Outcome measures

Outcome measures
Measure	Apremilast n=10 Participants Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability. Apremilast: 30 mg BID
Proportion of Patients Who Achieve an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16.	2 Participants

SECONDARY outcome

Timeframe: Week 16

Population: An intention-to-treat analysis was performed using last observation carried forward and included all enrolled patients who received apremilast at Week 0.

Outcome measures

Outcome measures
Measure	Apremilast n=10 Participants Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability. Apremilast: 30 mg BID
Percentage of Subjects Achieving Body Surface Area Less Than 3% at Week 16	4 Participants

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: An intention-to-treat analysis was performed using last observation carried forward and included all enrolled patients who received apremilast at Week 0.

Outcome measures

Outcome measures
Measure	Apremilast n=10 Participants Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability. Apremilast: 30 mg BID
Body Surface Area (BSA) Involvement	5.5 percentage of BSA Standard Deviation 3.8

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: An intention-to-treat analysis was performed using last observation carried forward and included all enrolled patients who received apremilast at Week 0.

Outcome measures

Outcome measures
Measure	Apremilast n=10 Participants Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability. Apremilast: 30 mg BID
Body Surface Area (BSA) Involvement	-37.6 percent change Standard Deviation 26.6

SECONDARY outcome

Timeframe: baseline to Week 16

Population: An intention-to-treat analysis was performed using last observation carried forward and included all enrolled patients who received apremilast at Week 0.

10-item questionnaire that measures how much the subjects' skin disease has affected their quality of life over the past week. Total score range 0 to 30, a score equal to zero (0) represents no impact and a score equal to thirty (30) represents severe impact on quality of life.

Outcome measures

Outcome measures
Measure	Apremilast n=10 Participants Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability. Apremilast: 30 mg BID
Dermatology Life Quality Index (DLQI) Score	3.7 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: baseline to Week 16

Population: An intention-to-treat analysis was performed using last observation carried forward and included all enrolled patients who received apremilast at Week 0.

10-item questionnaire that measures how much the subjects' skin disease has affected their quality of life over the past week. Total score range 0 to 30, a score equal to zero (0) represents no impact and a score equal to thirty (30) represents severe impact on quality of life.

Outcome measures

Outcome measures
Measure	Apremilast n=10 Participants Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability. Apremilast: 30 mg BID
Dermatology Life Quality Index (DLQI) Score	-36.9 percent change Standard Deviation 54.8

SECONDARY outcome

Timeframe: Baseline - Week 16

Population: An intention-to-treat analysis was performed using last observation carried forward and included all enrolled patients who received apremilast at Week 0.

zero (0) to ten (10) numerical rating scale, zero equals no itch and ten equals worst itch imaginable.

Outcome measures

Outcome measures
Measure	Apremilast n=10 Participants Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability. Apremilast: 30 mg BID
Numerical Rating Scale (NRS) Pruritus Scale	2.9 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline - Week 16

Population: An intention-to-treat analysis was performed using last observation carried forward and included all enrolled patients who received apremilast at Week 0.

zero (0) to ten (10) numerical rating scale, zero equals no itch and ten equals worst itch imaginable.

Outcome measures

Outcome measures
Measure	Apremilast n=10 Participants Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability. Apremilast: 30 mg BID
Numerical Rating Scale (NRS) Pruritus Scale	-45.9 percent change Standard Deviation 17.8

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: An intention-to-treat analysis was performed using last observation carried forward and included all enrolled patients who received apremilast at Week 0.

score ranges from zero (0) to seventy- two (72), 0 indicates no active eczema / atopic dermatitis, max score 72 indicates severe eczema involvement of all body regions.

Outcome measures

Outcome measures
Measure	Apremilast n=10 Participants Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability. Apremilast: 30 mg BID
Eczema Area and Severity Index (EASI) Score	4.4 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: An intention-to-treat analysis was performed using last observation carried forward and included all enrolled patients who received apremilast at Week 0.

score ranges from zero (0) to seventy- two (72), 0 indicates no active eczema / atopic dermatitis, max score 72 indicates severe eczema involvement of all body regions.

Outcome measures

Outcome measures
Measure	Apremilast n=10 Participants Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability. Apremilast: 30 mg BID
Eczema Area and Severity Index (EASI) Score	-32.6 percent change Standard Deviation 42.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Safety and tolerability will be evaluated by tabulations of adverse events

Outcome measures

Outcome data not reported

Adverse Events

Apremilast

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Apremilast n=10 participants at risk Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability. Apremilast: 30 mg BID
Gastrointestinal disorders Gastrointestinal (GI) disturbances	50.0% 5/10 • Number of events 5 • From Baseline - week 24
General disorders Headache	40.0% 4/10 • Number of events 4 • From Baseline - week 24

Additional Information

Study Coordinator

Tufts Medical Center

Phone: 617-636-1579

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place