Trial · NCT02002208
Effect of OC000459 on Moderate to Severe Atopic Dermatitis
NCT02002208, Phase 2, Completed, Atopix Therapeutics, Ltd.; results first posted 2016-12-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of OC000459 on Moderate to Severe Atopic Dermatitis. Trials, record NCT02002208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02002208
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of OC000459 on Moderate to Severe Atopic Dermatitis
- NCT number
- NCT02002208
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 142 participants, actual
- Lead sponsor
- Atopix Therapeutics, Ltd.
- Conditions
- Atopic Dermatitis
- Interventions
- OC000459
- First posted
- 2013-12-05
- Last updated
- 2018-03-26
- Results first posted
- 2016-12-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16 | EASI was measured at baseline (week 0) and 16 weeks after dosing. | 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. |
| Secondary | Rate of Flares | over 16 weeks |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16 | EASI was measured at baseline (week 0) and 16 weeks after dosing. | Adjusted mean change from baseline EASI at Week 16 | units on a scale | MEAN |
| SECONDARY | Rate of Flares | over 16 weeks | flares | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16 | OC000459 Tablets | -3.8 | Standard Error 1.72 | units on a scale | |
| Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16 | Placebo Tablets | -6.1 | Standard Error 1.71 | units on a scale | |
| Rate of Flares | OC000459 Tablets | 2.879 | Standard Deviation 2.8679 | flares | |
| Rate of Flares | Placebo Tablets | 2.646 | Standard Deviation 4.7922 | flares |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OC000459 Tablets | 69 | |
| Overall Study | STARTED | Placebo Tablets | 70 | |
| Overall Study | COMPLETED | OC000459 Tablets | 32 | |
| Overall Study | COMPLETED | Placebo Tablets | 30 | |
| Overall Study | NOT COMPLETED | OC000459 Tablets | 37 | |
| Overall Study | NOT COMPLETED | Placebo Tablets | 40 |
Source ClinicalTrials.gov
Adverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | OC000459 Tablets | 15 | 70 | |
| other | Headache | Nervous system disorders | Placebo Tablets | 15 | 71 | |
| other | Nasopharyngitis | Infections and infestations | OC000459 Tablets | 9 | 70 | |
| other | Nasopharyngitis | Infections and infestations | Placebo Tablets | 15 | 71 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | OC000459 Tablets | 6 | 70 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo Tablets | 4 | 71 | |
| other | Herpes simplex | Infections and infestations | OC000459 Tablets | 4 | 70 | |
| other | Herpes simplex | Infections and infestations | Placebo Tablets | 2 | 71 | |
| other | Nausea | Gastrointestinal disorders | OC000459 Tablets | 3 | 70 | |
| other | Nausea | Gastrointestinal disorders | Placebo Tablets | 4 | 71 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OC000459 Tablets | ||
| Total, all-cause mortality | Placebo Tablets | ||
| Total, other adverse events | OC000459 Tablets | 52 | 70 |
| Total, other adverse events | Placebo Tablets | 47 | 71 |
| Total, serious adverse events | OC000459 Tablets | 2 | 70 |
| Total, serious adverse events | Placebo Tablets | 6 | 71 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| OC000459 Tablets vs Placebo Tablets: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02002208
GET https://conductscience.org/api/trials/v1/NCT02002208/events?page=2