Trial · NCT03072953

Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum

NCT03072953, Phase 2, Terminated, Arena Pharmaceuticals; results first posted 2021-06-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum. Trials, record NCT03072953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03072953

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum
NCT number: NCT03072953
Status: Terminated
Phases: Phase 2
Enrollment: 2 participants, actual
Lead sponsor: Arena Pharmaceuticals
Conditions: Pyoderma Gangrenosum
Interventions: APD334
First posted: 2017-03-08
Last updated: 2021-06-11
Results first posted: 2021-06-11
Limitations and caveats: Due to limited enrollment (N=2), this clinical trial was terminated by the Sponsor and no efficacy analyses were conducted. To protect the participant's privacy, demography and efficacy data are not reported.

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Exploratory Endpoint - Change From Baseline in Physician Global Assessments for Active Skin Manifestations	Week 12	The physician's global assessment for active skin manifestations recorded the number of ulcers, target lesion noted for endpoint evaluation, diameters of each target lesion and score of evaluation at each visit. The scores ranged from 0 (total resolution) to 4 (no evidence of healing).
Primary	Exploratory Endpoint - Change From Baseline in Patient Global Assessments for Active Skin Manifestations	Week 12	The patient global assessment for active skin manifestation recorded the disease and pain severity using a visual analogue to mark the participant's score. Participants were asked to rate their disease severity from "not severe" to "extremely severe" and pain levels from "no pain at all' to "worst pain imaginable" in the past one week.
Primary	Exploratory Endpoint - Change From Baseline in Dermatology Life Quality Index (DLQI) Score	Week 12	The DLQI questionnaire assessed how much a participant's life is affected through their skin problem in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure and sport activities, work or school activities, personal relationships and treatment- related feelings. Participants responded to the 10 questions on a scale from 0 (not at all) to 3 (very much) with a total score ranging from 0 to 30. Higher scores indicated that the skin problem had an extremely large effect on the participant's life whereas lower scores indicated that the disease has minimal to no effect at all.
Primary	Exploratory Endpoint - Change From Baseline in C-reactive Protein Levels	Week 12
Primary	Exploratory Endpoint - Assessments of Target Lesions	Week 12	Changes in surface area
Primary	Exploratory Endpoint - Assessment of Punch Biopsies	Week 12	Changes in histology.
Other	Number of Participants With Adverse Events and Clinically Significant (CS) Safety Measurements	Up to approximately 12 weeks	Safety was assessed by monitoring and recording all adverse events, clinical laboratory tests (including hematology, serum chemistry, coagulation, and urinalysis), physical and neurological examinations, vital sign measurements, and 12-lead electrocardiograms. The number of participants with adverse events and CS safety measures have been reported.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Exploratory Endpoint - Change From Baseline in Physician Global Assessments for Active Skin Manifestations	Week 12	Efficacy analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
PRIMARY	Exploratory Endpoint - Change From Baseline in Patient Global Assessments for Active Skin Manifestations	Week 12	Efficacy analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
PRIMARY	Exploratory Endpoint - Change From Baseline in Dermatology Life Quality Index (DLQI) Score	Week 12	Efficacy analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
PRIMARY	Exploratory Endpoint - Change From Baseline in C-reactive Protein Levels	Week 12	Efficacy analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
PRIMARY	Exploratory Endpoint - Assessments of Target Lesions	Week 12	Efficacy analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
PRIMARY	Exploratory Endpoint - Assessment of Punch Biopsies	Week 12	Efficacy analyses were not conducted due to low enrollment (N=2). In order to protect participant's privacy, the results from the enrolled participants cannot be reported.
OTHER_PRE_SPECIFIED	Number of Participants With Adverse Events and Clinically Significant (CS) Safety Measurements	Up to approximately 12 weeks	All enrolled participants	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Events and Clinically Significant (CS) Safety Measurements	APD334	Adverse events	2	Participants
Number of Participants With Adverse Events and Clinically Significant (CS) Safety Measurements	APD334	CS clinical laboratory values	0	Participants
Number of Participants With Adverse Events and Clinically Significant (CS) Safety Measurements	APD334	CS physical & neurological examinations	0	Participants
Number of Participants With Adverse Events and Clinically Significant (CS) Safety Measurements	APD334	CS vital sign measurements	0	Participants
Number of Participants With Adverse Events and Clinically Significant (CS) Safety Measurements	APD334	CS 12-lead ECG measurements	0	Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	APD334	2
Overall Study	COMPLETED	APD334	2
Overall Study	NOT COMPLETED	APD334	0

Source ClinicalTrials.gov

Adverse events4

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
other	Diarrhea	Gastrointestinal disorders	APD334	1	2
other	headache	Nervous system disorders	APD334	1	2
other	Pruritus	Skin and subcutaneous tissue disorders	APD334	1	2
other	Sore hip	Injury, poisoning and procedural complications	APD334	1	2

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	APD334	0	2
Total, other adverse events	APD334	2	2
Total, serious adverse events	APD334	0	2

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03072953

GET https://conductscience.org/api/trials/v1/NCT03072953/registered

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