18 and older, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From BaselinePrimary· Baseline to Week 16
The ScPGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. When making the assessment of overall scalp severity, the investigator factored in areas that had already been cleared (ie, had scores of 0), not limited to the evaluation of remaining lesions for severity; consequently, the severity of each sign was averaged across all areas of involvement, including cle
Group
Value
95% CI
Placebo/Apremilast
13.7
6.6 – 20.8
Apremilast
43.3
36.2 – 50.5
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16Secondary· Baseline to Week 16
The Whole Body Itch NRS scale is an 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity. NRS response was defined as a ≥ 4-point reduction (improvement) from baseline.
Group
Value
95% CI
Placebo/Apremilast
22.5
13.7 – 31.3
Apremilast
45.5
38.1 – 52.9
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch Numeric Rating Score (NRS) at Week 16Secondary· Baseline to Week 16
The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.
Group
Value
95% CI
Placebo/Apremilast
21.1
11.8 – 30.3
Apremilast
47.1
39.5 – 54.7
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled PhaseSecondary· Baseline to Weeks 2, 4, 6, 8 and 12
The Whole Body Itch NRS scale is a 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity.
Week 2
Group
Value
95% CI
Placebo/Apremilast
3.5
-0.4 – 7.4
Apremilast
20.5
14.6 – 26.4
Week 4
Group
Value
95% CI
Placebo/Apremilast
10.1
3.9 – 16.3
Apremilast
32.3
25.4 – 39.1
Week 8
Group
Value
95% CI
Placebo/Apremilast
19.7
11.4 – 27.9
Apremilast
39.8
32.6 – 47.1
Week 12
Group
Value
95% CI
Placebo/Apremilast
26.3
17.0 – 35.7
Apremilast
47.0
39.6 – 54.3
Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled PhaseSecondary· Baseline to Weeks 2, 4, 8 and 12
The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.
Week 2
Group
Value
95% CI
Placebo/Apremilast
11.5
4.8 – 18.2
Apremilast
26.1
19.5 – 32.7
Week 4
Group
Value
95% CI
Placebo/Apremilast
16.5
8.7 – 24.4
Apremilast
37.8
30.5 – 45.0
Week 8
Group
Value
95% CI
Placebo/Apremilast
23.7
14.6 – 32.9
Apremilast
45.6
38.1 – 53.2
Week 12
Group
Value
95% CI
Placebo/Apremilast
19.6
10.6 – 28.5
Apremilast
46.5
38.9 – 54.1
Change From Baseline in Dermatological Life Quality Index (DLQI) Total Score at Week 16Secondary· Baseline to Week 16
DLQI is 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 subject is asked how much of a pro
Group
Value
95% CI
Placebo/Apremilast
-3.8
± 0.56
Apremilast
-6.7
± 0.41
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled PhaseSecondary· Week 0 to Week 16; mean duration of exposure was 14.5 weeks and 14.6 weeks for participants randomized to placebo and apremilast respectively.
A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagn
Any TEAE
Group
Value
95% CI
Apremilast
135
Placebo/Apremilast
52
Any Drug-related TEAE
Group
Value
95% CI
Apremilast
99
Placebo/Apremilast
22
Any Severe TEAE
Group
Value
95% CI
Apremilast
5
Placebo/Apremilast
2
Any Serious TEAE
Group
Value
95% CI
Apremilast
2
Placebo/Apremilast
1
Any TEAE Leading to Drug Interruption
Group
Value
95% CI
Apremilast
9
Placebo/Apremilast
4
Any TEAE Leading to Drug Withdrawal
Group
Value
95% CI
Apremilast
11
Placebo/Apremilast
3
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension PhaseSecondary· Weeks 16 to Week 32; the mean treatment duration was 14.6 weeks and 15.3 weeks in the APR 30/APR 30 BID and placebo/APR 30 BID arms, respectively
A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagn
Any TEAE
Group
Value
95% CI
Placebo/Apremilast
35
Apremilast
66
Any Drug-related TEAE
Group
Value
95% CI
Placebo/Apremilast
17
Apremilast
17
Any Severe TEAE
Group
Value
95% CI
Placebo/Apremilast
2
Apremilast
4
Any Serious TEAE
Group
Value
95% CI
Placebo/Apremilast
1
Apremilast
5
Any TEAE Leading to Drug Interruption
Group
Value
95% CI
Placebo/Apremilast
2
Apremilast
4
Any TEAE Leading to Drug Withdrawal
Group
Value
95% CI
Placebo/Apremilast
1
Apremilast
4
Deaths
Group
Value
95% CI
Placebo/Apremilast
0
Apremilast
0
Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure PeriodSecondary· Week 0 to 32;
The apremilast-exposure period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast. A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomal
Any TEAE
Group
Value
95% CI
Placebo/Apremilast
35
Apremilast
144
Any Drug-related TEAE
Group
Value
95% CI
Placebo/Apremilast
17
Apremilast
103
Any Severe TEAE
Group
Value
95% CI
Placebo/Apremilast
2
Apremilast
8
Any Serious TEAE
Group
Value
95% CI
Placebo/Apremilast
1
Apremilast
6
Any Serious TEAE Drug Related TEAE
Group
Value
95% CI
Placebo/Apremilast
0
Apremilast
3
Any TEAE Leading to Drug Interruption
Group
Value
95% CI
Placebo/Apremilast
2
Apremilast
13
Any TEAE Leading to Drug Withdrawal
Group
Value
95% CI
Placebo/Apremilast
1
Apremilast
15
Deaths
Group
Value
95% CI
Placebo/Apremilast
0
Apremilast
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From the date of randomization to 28 days after the last dose of study drug. AEs are reported for the placebo-controlled phase from Week 0 to Week 16 and for the apremilast extension phase from Week 16 to Week 32;.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp.
Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07398651 — Apremilast and Adalimumab in Psoriatic Arthritis Patients
· NA
· not yet recruiting
NCT07325266 — Human Laboratory Study of Apremilast for Alcohol Use Disorder
· Phase 2
· recruiting
NCT07432386 — Methotrexate Versus Apremilast for Pruritus in Psoriasis
· Phase 4
· not yet recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
· Phase 4
· not yet recruiting
NCT07337434 — To Check Comparison of Apremilast and Methotrexate Efficacy in Patients With Moderate to Severe Plaque Psoriasis Present
· EARLY_PHASE1
· recruiting
Other recruiting trials for Psoriasis
Currently open trials in the same condition.
NCT07471048 — A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoria
· NA
· recruiting
NCT07449234 — A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis
· recruiting
NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
· recruiting
NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial
· Phase 2
· recruiting
NCT07250997 — PALLAS Laser for Skin Diseases
· NA
· recruiting
Other Amgen trials
Trials by the same sponsor.
NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly
· Phase 3
· not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer
· Phase 1
· not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
· Phase 1
· not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen
· Phase 2
· recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 13 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03123471.