Trial Outcomes & Findings for Effect of OC000459 on Moderate to Severe Atopic Dermatitis (NCT NCT02002208)
NCT ID: NCT02002208
Last Updated: 2018-03-26
Results Overview
The EASI scoring system uses a defined process to grade the severity of the signs of eczema and the extent affected in four regions of the body: head and neck, trunk, upper extremities and lower extremities. The scale ranges from 0 to 72 and the severity strata for the EASI are as follows: 0 clear; 0.1-1.0 almost clear; 1.1-7.0 mild; 7.1-21.0 =moderate; 21.1-50.0 severe; 50.1-72.0 very severe. When assessing response to therapy a reduction of 7 or more is considered to be clinically meaningful.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
EASI was measured at baseline (week 0) and 16 weeks after dosing.
Results posted on
2018-03-26
Participant Flow
142 patients were randomised. One patient withdrew prior to dosing meaning that there was 141 patients in the safety set. 2 further patients withdrew prior to the first efficacy measurement which means there were 139 patients in the full analysis set.
Participant milestones
| Measure |
OC000459 Tablets
50 mg orally once a day
OC000459: CRTH2 inhibitor
|
Placebo Tablets
Orally once a day
OC000459: CRTH2 inhibitor
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
70
|
|
Overall Study
COMPLETED
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
37
|
40
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of OC000459 on Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
OC000459 Tablets
n=69 Participants
50 mg orally once a day
OC000459: CRTH2 inhibitor
|
Placebo Tablets
n=70 Participants
Orally once a day
OC000459: CRTH2 inhibitor
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
30.9 years
STANDARD_DEVIATION 8.54 • n=7 Participants
|
31.2 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: EASI was measured at baseline (week 0) and 16 weeks after dosing.Population: Adjusted mean change from baseline EASI at Week 16
The EASI scoring system uses a defined process to grade the severity of the signs of eczema and the extent affected in four regions of the body: head and neck, trunk, upper extremities and lower extremities. The scale ranges from 0 to 72 and the severity strata for the EASI are as follows: 0 clear; 0.1-1.0 almost clear; 1.1-7.0 mild; 7.1-21.0 =moderate; 21.1-50.0 severe; 50.1-72.0 very severe. When assessing response to therapy a reduction of 7 or more is considered to be clinically meaningful.
Outcome measures
| Measure |
OC000459 Tablets
n=69 Participants
50 mg orally once a day
OC000459: CRTH2 inhibitor
|
Placebo Tablets
n=70 Participants
Orally once a day
|
|---|---|---|
|
Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16
|
-3.8 units on a scale
Standard Error 1.72
|
-6.1 units on a scale
Standard Error 1.71
|
SECONDARY outcome
Timeframe: over 16 weeksOutcome measures
| Measure |
OC000459 Tablets
n=69 Participants
50 mg orally once a day
OC000459: CRTH2 inhibitor
|
Placebo Tablets
n=70 Participants
Orally once a day
|
|---|---|---|
|
Rate of Flares
|
2.879 flares
Standard Deviation 2.8679
|
2.646 flares
Standard Deviation 4.7922
|
Adverse Events
OC000459 Tablets
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo Tablets
Serious events: 6 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OC000459 Tablets
n=70 participants at risk
50 mg orally once a day
OC000459: CRTH2 inhibitor
|
Placebo Tablets
n=71 participants at risk
Orally once a day
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Worsening atopic dermatitis
|
1.4%
1/70 • Up to 6 months
Standardised coding using MedDRA
|
4.2%
3/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
1.4%
1/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
1.4%
1/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Investigations
ECG abnormality
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
1.4%
1/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
1.4%
1/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Blood and lymphatic system disorders
Solitary Plasmacytoma
|
1.4%
1/70 • Up to 6 months
Standardised coding using MedDRA
|
0.00%
0/71 • Up to 6 months
Standardised coding using MedDRA
|
Other adverse events
| Measure |
OC000459 Tablets
n=70 participants at risk
50 mg orally once a day
OC000459: CRTH2 inhibitor
|
Placebo Tablets
n=71 participants at risk
Orally once a day
|
|---|---|---|
|
Nervous system disorders
Headache
|
21.4%
15/70 • Up to 6 months
Standardised coding using MedDRA
|
21.1%
15/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Infections and infestations
Nasopharyngitis
|
12.9%
9/70 • Up to 6 months
Standardised coding using MedDRA
|
21.1%
15/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
6/70 • Up to 6 months
Standardised coding using MedDRA
|
5.6%
4/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Infections and infestations
Herpes simplex
|
5.7%
4/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Gastrointestinal disorders
Nausea
|
4.3%
3/70 • Up to 6 months
Standardised coding using MedDRA
|
5.6%
4/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Gastrointestinal disorders
Tooth ache
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
4.2%
3/71 • Up to 6 months
Standardised coding using MedDRA
|
|
General disorders
Fatigue
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
4.2%
3/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
1/70 • Up to 6 months
Standardised coding using MedDRA
|
4.2%
3/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Infections and infestations
Cystitis
|
2.9%
2/70 • Up to 6 months
Standardised coding using MedDRA
|
0.00%
0/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Infections and infestations
Ear infection
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Infections and infestations
Rash pustular
|
2.9%
2/70 • Up to 6 months
Standardised coding using MedDRA
|
0.00%
0/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Nervous system disorders
Dizziness
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
8.6%
6/70 • Up to 6 months
Standardised coding using MedDRA
|
7.0%
5/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
2/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Eye disorders
Conjunctivitis
|
2.9%
2/70 • Up to 6 months
Standardised coding using MedDRA
|
1.4%
1/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
3/70 • Up to 6 months
Standardised coding using MedDRA
|
1.4%
1/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
2/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
General disorders
Chest pain
|
2.9%
2/70 • Up to 6 months
Standardised coding using MedDRA
|
0.00%
0/71 • Up to 6 months
Standardised coding using MedDRA
|
|
General disorders
Influenza like illness
|
2.9%
2/70 • Up to 6 months
Standardised coding using MedDRA
|
0.00%
0/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Psychiatric disorders
Insomnia
|
2.9%
2/70 • Up to 6 months
Standardised coding using MedDRA
|
0.00%
0/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
|
Immune system disorders
Food allergy
|
1.4%
1/70 • Up to 6 months
Standardised coding using MedDRA
|
2.8%
2/71 • Up to 6 months
Standardised coding using MedDRA
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place