Trial · NCT01194219

Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis

NCT01194219, Phase 3, Completed, Amgen; results first posted 2014-11-05

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis. Trials, record NCT01194219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01194219

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Trial

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

Title: Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis
NCT number: NCT01194219
Status: Completed
Phases: Phase 3
Enrollment: 844 participants, actual
Lead sponsor: Amgen
Conditions: Plaque Psoriasis
Interventions: Apremilast, Placebo, Topical treatments or phototherapy
First posted: 2010-09-02
Last updated: 2022-03-15
Results first posted: 2014-11-05

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline	Baseline to Week 16	PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.
Secondary	Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With At Least 2 Points Reduction From Baseline	Baseline to Week 16	The sPGA was a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator factored in areas that have already been cleared (ie, have scores of 0) and did not just evaluate remaining lesions for severity, ie, the severity of each sign was averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.
Secondary	Percent Change From Baseline in Percent of Affected Body Surface Area (BSA) at Week 16	Baseline and Week 16	BSA was a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline (Visit 2 Week 0) was determined at each visit of the study, which is calculated as 100\*(visit BSA - baseline BSA) / baseline BSA (%).
Secondary	Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16	Baseline to Week 16	Psoriasis Area Severity Index (PASI) scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. The PASI score was set to missing if any severity score or degree of involvement is missing. PASI score percent change from baseline was calculated as 100\* (visit score - baseline score)/baseline score (%).
Secondary	Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline	Baseline to Week 16	A participant was classified as having at least a 50% improvement in PASI score from baseline, which was equivalent to a percent change from baseline ranging from -100% to -50%. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.
Secondary	Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16	Baseline and Week 16	The Pruritus Visual Analog Scores (VAS) were used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. Change from baseline was calculated for the VAS scale, where change = visit value - baseline value.
Secondary	Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16	Baseline to Week 16	DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
Secondary	Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16	Baseline to Week 16	The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.
Secondary	Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction at Week 16 From Baseline	Baseline to Week 16	PASI-75 response was the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. See Outcome Measure #1 for further description. sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. See OCM #2 for further description.
Secondary	Kaplan Meier Estimate of Time to Loss of PASI-75 Response (Loss of Effect) at Week 32 During the Re-Randomized Treatment Withdrawal Phase	Week 32 to Week 52	Time to loss was the time between the re-randomization date and the date of the first assessment where loss of PASI-75 was observed (event); or the time between the re-randomization date and the date of the last PASI assessment in the Weeks 32-52 interval prior to addition of protocol-prohibited medication/therapy, or resumption of APR 30 BID, or discontinuation, or Week 52 if no loss (censored).

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline	Baseline to Week 16	The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With At Least 2 Points Reduction From Baseline	Baseline to Week 16	The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.	percentage of participants	NUMBER
SECONDARY	Percent Change From Baseline in Percent of Affected Body Surface Area (BSA) at Week 16	Baseline and Week 16	The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Participants with a baseline value and at least 1 postbaseline value were included. Last observation carried forward imputation was used.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16	Baseline to Week 16	The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included .	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline	Baseline to Week 16	The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.	Percentage of Participants	NUMBER
SECONDARY	Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16	Baseline and Week 16	The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16	Baseline to Week 16	The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16	Baseline to Week 16	The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction at Week 16 From Baseline	Baseline to Week 16	The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.	percentage of participants	NUMBER
SECONDARY	Kaplan Meier Estimate of Time to Loss of PASI-75 Response (Loss of Effect) at Week 32 During the Re-Randomized Treatment Withdrawal Phase	Week 32 to Week 52	Analysis population consisted of participants who were re-randomized to placebo or apremilast 30mg BID at Week 32.	Weeks	MEDIAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group53

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

Outcome	Group	Value	Spread	Units
Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline	Placebo/Apremilast	33.1		percentage of participants
Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline	Placebo (PBO)	5.3		percentage of participants
Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With At Least 2 Points Reduction From Baseline	Apremilast	21.7		percentage of participants
Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With At Least 2 Points Reduction From Baseline	Placebo	3.9		percentage of participants
Percent Change From Baseline in Percent of Affected Body Surface Area (BSA) at Week 16	Apremilast	-47.77	Standard Error 1.634	percent change
Percent Change From Baseline in Percent of Affected Body Surface Area (BSA) at Week 16	Placebo	-6.99	Standard Error 2.317	percent change
Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16	Placebo/Apremilast	-52.1	Standard Error 1.37	percent change
Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16	Placebo	-16.8	Standard Error 1.94	percent change
Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline	Placebo/Apremilast	58.7		Percentage of Participants
Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline	Placebo	17.0		Percentage of Participants

1 to 10 of 53Source ClinicalTrials.gov

See all 53 results by group

Participant flow160

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

Period	Milestone	Group	Participants
Placebo-Controlled Phase Weeks 0-16	STARTED	Apremilast	562
Placebo-Controlled Phase Weeks 0-16	STARTED	Placebo	282
Placebo-Controlled Phase Weeks 0-16	STARTED	Apremilast-Apremilast	0
Placebo-Controlled Phase Weeks 0-16	STARTED	Placebo-Apremilast	0
Placebo-Controlled Phase Weeks 0-16	STARTED	APR-APR-Re-randomized to PBO	0
Placebo-Controlled Phase Weeks 0-16	STARTED	APR-APR-Re-randomized to APR	0
Placebo-Controlled Phase Weeks 0-16	STARTED	APR-APR-APR + Optional Topicals/UVB	0
Placebo-Controlled Phase Weeks 0-16	STARTED	PBO-APR-APR + Optional Topicals/ UVB	0
Placebo-Controlled Phase Weeks 0-16	STARTED	Apremilast (Long-term Extension)	0
Placebo-Controlled Phase Weeks 0-16	STARTED	Placebo-Apremilast (Long-term Extension)	0

1 to 10 of 160Source ClinicalTrials.gov

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Adverse events396

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	Diarrhoea	Gastrointestinal disorders	Placebo (Placebo-Controlled Phase) Weeks 0-16	20	282
other	Diarrhoea	Gastrointestinal disorders	Apremilast (Placebo-Controlled Phase) Weeks 0-16	105	560
other	Diarrhoea	Gastrointestinal disorders	APR-APR-PBO Randomized Withdrawal Phase Weeks 32-52	0	77
other	Diarrhoea	Gastrointestinal disorders	Apremilast (Apremilast Exposure Period) Weeks 0-260	163	804
other	Nausea	Gastrointestinal disorders	Placebo (Placebo-Controlled Phase) Weeks 0-16	19	282
other	Nausea	Gastrointestinal disorders	Apremilast (Placebo-Controlled Phase) Weeks 0-16	88	560
other	Nausea	Gastrointestinal disorders	APR-APR-PBO Randomized Withdrawal Phase Weeks 32-52	0	77
other	Nausea	Gastrointestinal disorders	Apremilast (Apremilast Exposure Period) Weeks 0-260	130	804
other	Gastroenteritis	Infections and infestations	Placebo (Placebo-Controlled Phase) Weeks 0-16	6	282
other	Gastroenteritis	Infections and infestations	Apremilast (Placebo-Controlled Phase) Weeks 0-16	10	560

1 to 10 of 396Source ClinicalTrials.gov

See all 396 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo (Placebo-Controlled Phase) Weeks 0-16
Total, all-cause mortality	Apremilast (Placebo-Controlled Phase) Weeks 0-16
Total, all-cause mortality	APR-APR-PBO Randomized Withdrawal Phase Weeks 32-52
Total, all-cause mortality	Apremilast (Apremilast Exposure Period) Weeks 0-260
Total, other adverse events	Placebo (Placebo-Controlled Phase) Weeks 0-16	90	282
Total, other adverse events	Apremilast (Placebo-Controlled Phase) Weeks 0-16	260	560
Total, other adverse events	APR-APR-PBO Randomized Withdrawal Phase Weeks 32-52	10	77
Total, other adverse events	Apremilast (Apremilast Exposure Period) Weeks 0-260	503	804
Total, serious adverse events	Placebo (Placebo-Controlled Phase) Weeks 0-16	8	282
Total, serious adverse events	Apremilast (Placebo-Controlled Phase) Weeks 0-16	12	560

1 to 10 of 12Source ClinicalTrials.gov

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Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34255891	RESULT	PubMed
37316690	DERIVED	PubMed

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.

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