Oral DS107 in Moderate to Severe Atopic Dermatitis

A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS107G to Patients With Moderate to Severe Atopic Dermatitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02211417

Enrollment

102

Registered

2014-08-07

Start date

2015-01-31

Completion date

2015-12-31

Last updated

2022-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

This study will compare the safety and efficacy of Oral DS107 (2 g) to placebo in patients with moderate to severe atopic dermatitis. Oral DS107 (2 g) will be orally administered for 8 weeks, and will be compared against placebo. This study will enroll approximately 100 adult patients.

Detailed description

Subjects will come to the clinic on 6 occasions: at screening, baseline, week 2, week 4, week 8 (end of treatment/early termination) and week 10 (follow-up). The primary efficacy variable will be the IGA. Secondary efficacy variables will include IGA (Investigator's Global Assessment), SCORAD (Scoring Atopic Dermatitis) Visual Analog Scale (VAS), EASI, BSA (Body Surface Area), POEM (Patient Orientated Eczema Measure), DLQI (Dermatology Life Quality Index).

Interventions

DRUGOral DS107

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female subject aged 18 years and older. * Moderate to severe atopic dermatitis.

Exclusion criteria

* Clinically significant impairment of renal or hepatic function. * History of hypersensitivity to any substance in Oral DS107 or placebo capsules. * Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline). * Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources and/or is planning a trip to sunny climate.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.	Week 8	The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.

Secondary

Measure	Time frame	Description
Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8.	Baseline, Week 2, Week 4 and Week 8	EASI quantifies the severity of a patient's AD based on both lesion severity and the percent of BSA affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted): * 0 = no symptoms * 1 = slight * 2 = moderate * 3 = marked A decrease in EASI score indicates a positive outcome for the participant.
Proportion of Patients Achieving at Least a 1-point Decrease in IGA at Week 8.	Up to 8 weeks.	The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8.	Baseline, Week 2, Week 4 and Week 8	The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the patient. POEM has a maximum value of twenty-eight based on the patient's response to seven questions scored according to the following scale: * No Days = 0 * 1-2 Days = 1 * 3-4 Days = 2 * 5-6 Days = 3 * Everyday = 4 POEM scale ranges from 0 to 28. 0 to 2 = clear or almost clear. 3 to 7 = mild eczema. 8 to 16 = moderate eczema. 17 to 24 = severe eczema. 25 to 28 = very severe eczema. Lower scores on the scale represent a better outcome for the patient.
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8.	Baseline, Week 2, Week 4 and Week 8	The DLQI is a simple 10-question validated questionnaire measuring the impact of a patients skin problem over a 1 week period, which was completed at each visit, except screening. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Change From Baseline in IGA at Week 2, 4 and 8.	Baseline, Week 2, Week 4 and Week 8	The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8.	Baseline, Week 2, Week 4 and Week 8	The pruritus severity score was recorded with the SCORAD measurement and was evaluated as a separate endpoint. This was evaluated by asking subjects to indicate on the 10-cm scale (0-10) of the assessment form the point corresponding to the average value for the last three days/nights. A lower score represents a better outcome for the patient.
Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8.	Baseline, Week 2, Week 4 and Week 8	One patient's palm represents 1% of his/her total BSA. For all study visits except at screening, the BSA of involved skin will be measured with the SCORAD measurement and evaluated as a separate endpoint.
Number of Participants With TEAEs in Each Treatment Group	Up to 14 weeks	Number of participants with at least 1 TEAE.
Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8.	Baseline, Week 2, Week 4 and Week 8	The SCORAD grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess the AD severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) was selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale: * 0 = No symptoms * 1 = Mild * 2 = Moderate * 3 = Severe The overall BSA affected by AD was evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by patients on a visual analog scale (0-10). The sum of these measures represents the SCORAD which can vary from 0 to 103. A decrease in SCORAD indicates a positive outcome for the participant.

Countries

Canada, United States

Participant flow

Recruitment details

The study was conducted in 2 countries at 17 sites.

Pre-assignment details

A total of 102 patients were randomised. Patients were randomised (1:1) at baseline visit to either receive Oral DS107 capsules (2 g) or Placebo once daily for 8 weeks in a fasting state (minimum 8 hour fast).

Participants by arm

Arm	Count
Placebo Placebo capsules matching Oral DS107 capsules	51
Oral DS107 2g Oral DS107 2g, 4 x 500mg capsules administered orally once a day	51
Total	102

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	4
Overall Study	Lost to Follow-up	2	3
Overall Study	Pregnancy	0	1
Overall Study	Protocol Violation	1	0
Overall Study	Withdrawal by Subject	11	8

Baseline characteristics

Characteristic	Oral DS107 2g	Total	Placebo
Age, Continuous	35.7 years STANDARD_DEVIATION 13.6	39.8 years STANDARD_DEVIATION 15.2	43.9 years STANDARD_DEVIATION 15.7
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	4 Participants	3 Participants
Race (NIH/OMB) Asian	4 Participants	7 Participants	3 Participants
Race (NIH/OMB) Black or African American	16 Participants	35 Participants	19 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	30 Participants	56 Participants	26 Participants
Sex: Female, Male Female	30 Participants	53 Participants	23 Participants
Sex: Female, Male Male	21 Participants	49 Participants	28 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 51	0 / 51
other Total, other adverse events	23 / 51	37 / 51
serious Total, serious adverse events	1 / 51	0 / 51

Outcome results

Primary

Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.

The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.

Time frame: Week 8

Population: ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses.

Arm	Measure	Value (NUMBER)
Placebo	Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.	0.12 Proportion of participants
Oral DS107 2g	Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.	0.22 Proportion of participants

p-value: 0.057Cochran-Mantel-Haenszel

Secondary

Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8.

One patient's palm represents 1% of his/her total BSA. For all study visits except at screening, the BSA of involved skin will be measured with the SCORAD measurement and evaluated as a separate endpoint.