PsoriasisPhase 3ADVANCENCT03721172
Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy
A Phase 3 study testing Apremilast in people with Psoriasis, run by Amgen at 64 sites in 2 countries.
Trial summary
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 595 participants
- Where
- 64 sitesin 2 countries
- Study dates
- 11 Mar 2019to 24 Jul 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF).
- Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
- Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline.
- Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.
- Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
- Subject must meet laboratory criteria.
- Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subjects has any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- 2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB.
- 4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
- 5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
Show all 9Show fewer
- 6. Subject has prior history of suicide attempt at any time in the subject's life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 7. Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial.
- 8. Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
- 9. Subject had prior treatment with apremilast.
Trial locations and contacts
64 sites in 2 countries.
64 sites in 2 countries
United States43 sites
Atlanta Dermatology, Vein and Research Center, PC
Alpharetta, Georgia, 30022
Medical Dermatology Specialists, Inc. - Advanced Medical Research
Atlanta, Georgia, 30328
University of Colorado Hospital - Dermatology Clinic
Aurora, Colorado, 80045
ActivMed Practices & Research Inc
Beverly, Massachusetts, 01915
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, 35205
Massachusetts General Hospital
Boston, Massachusetts, 02114-2517
Total Vein and Skin, LLC
Boynton Beach, Florida, 33437
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Florida Academic Centers Research and Education
Coral Gables, Florida, 33134
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Wright State Physicians
Fairborn, Ohio, 45324
Johnson Dermatology Clinic
Fort Smith, Arkansas, 72916
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Clinical Partners, LLC
Johnston, Rhode Island, 02919
JDR Dermatology Research, LLC
Las Vegas, Nevada, 89148
Dermatology Research Associates
Los Angeles, California, 90045
Clinical Trials Management LLC
Metairie, Louisiana, 70006
International Dermatology Research
Miami, Florida, 33144
Center for Clinical and Cosmetic Research
Miami, Florida, 33180
Dermatology Center for Skin Health
Morgantown, West Virginia, 26505
University of Utah MidValley Dermatology
Murray, Utah, 84107
Icahn School of Medicine at Mount Sinai
New York, New York, 10003
MedaPhase INC
Newnan, Georgia, 30263
Virginia Clinical Research Inc
Norfolk, Virginia, 23502
Renstar Medical Research
Ocala, Florida, 34470
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Temple University - Lewis Katz School of Medicine
Philadelphia, Pennsylvania, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Derm Associates
Rockville, Maryland, 20850
Lawrence Green, MD, LLC
Rockville, Maryland, 20850
Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
Rogers, Arkansas, 72758
TCR Medical Corporation
San Diego, California, 92123
University of California San Francisco Psoriasis and Skin Treatment Center
San Francisco, California, 94118
Clinical Science Institute
Santa Monica, California, 90404
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078
Central Dermatology
St Louis, Missouri, 63117
University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
Tampa, Florida, 33612
Albert Einstein College of Medicine - Montefiore Medical Center
The Bronx, New York, 10467
Center for Clinical Studies
Webster, Texas, 77598
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104
Canada21 sites
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1
Institute for Skin Advancement
Calgary, Alberta, T3A 2N1
Dr Isabelle Delorme inc
Drummondville, Quebec, J2B 5L4
Stratica Medical
Edmonton, Alberta, T5K 1X3
Brunswick Dermatology Centre
Fredericton, New Brunswick, E3B 1G9
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7
DermEffects
London, Ontario, N6H 5L5
Lynderm Research
Markham, Ontario, L3P 1X2
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
Skin Center for Dermatology
Peterborough, Ontario, K9J 5K2
Dre Angelique Gagne-Henley M.D. Inc.
Saint-Jérôme, Quebec, J7Z 7E2
Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 0H6
Karma Clinical Trials
St. John's, Newfoundland and Labrador, A1A 4Y3
Chih-Ho Hong Medical, Inc.
Surrey, British Columbia, V3R 6A7
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
Toronto Research Centre
Toronto, Ontario, M3H 5Y8
Sameh Hanna Medicine Professional Corporation DBA Dermatology on Bloor
Toronto, Ontario, M4W 2N2
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
Windsor Clinical Research Inc.
Windsor, Ontario, N8W 5L7
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, R3CON2
SkinWise Dermatology
Winnipeg, Manitoba, R3M 3Z4
About this study
Official title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Mild to Moderate Plaque Psoriasis
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis.
Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.
Read the detailed description
The study will consist of four phases:
- Screening Phase - up to 35 days
- Double-blind Placebo-controlled Phase - Weeks 0 to 16
- Subjects will be randomly assigned to either apremilast 30 mg tablets orally BID or placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID.
- Apremilast Extension Phase - Weeks 16 to 32
- All subjects will be switched to (or continue with) apremilast 30 mg BID. All subjects will maintain this dosing through Week 32.
- Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue the study early.
- Conditions
- Psoriasis
- Being tested
- Apremilast, Placebo
- Keywords
- Phase 3, Double-Blind, Efficacy, Safety, Apremilast, Otezla, CC-10004, Plaque Psoriasis, Mild, Moderate, Scalp, Nail, Itch
- Medical subject headings
- Psoriasis, Lymphoma, Follicular, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Apremilast, oral, twice daily
PlaceboOther
Placebo, oral, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo-controlled Phase: | Experimental | Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). Receives: Other: Placebo |
| Placebo-controlled Phase: Apremilast 30 mg | Experimental | Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). Receives: Drug: Apremilast |
| Extension Phase: Apremilast 30 mg | Experimental | Eligible participants who completed the placebocontrolled phase entered the extension phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32). Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase
The sPGA is a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 =severe. Scores incorporate an assessment by the Investigator of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation.
An sPGA response is defined as sPGA score of clear (0) or almost clear (1) and with at least a 2-point reduction from baseline at Week 16.
Measured: Baseline and Week 16 of the placebo-controlled phase
Secondary outcomes (8)
Percentage of Participants With a ≥ 75 Percent (%) Improvement From Baseline in Affected Body Surface Area (BSA) at Week 16
The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or "handprints" (each entire palmar surface or "handprint" equates to approximately 1% of total body surface area).
Measured: Baseline and Week 16 of the placebo-controlled phase
Change From Baseline in Percentage of Affected BSA at Week 16
The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or "handprints" (each entire palmar surface or "handprint" equates to approximately 1% of total body surface area).
A negative change from baseline indicates a reduction of affected BSA.
Measured: Baseline and Week 16 of the placebo-controlled phase
Change From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 16
The PASI is 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. 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.
PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
A negative change from baseline indicates an improvement of disease symptoms.
Measured: Baseline and Week 16 of the placebo-controlled phase
Percentage of Participants Who Achieved BSA ≤ 3% for Participants With Baseline Affected BSA > 3% at Week 16
The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or "handprints" (each entire palmar surface or "handprint" equates to approximately 1% of total body surface area).
Measured: Baseline and Week 16 of the placebo-controlled phase
Percentage of Participants With ≥ 4-point Reduction From Baseline in Whole Body Itch Numeric Rating Scale (NRS) Score at Week 16 Who Had Baseline Whole Body Itch NRS ≥ 4
The whole body itch NRS is a self-reported measure where participants were asked to assess whole body itch and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch. A reduction in score from baseline represents an improvement in symptoms.
Measured: Baseline and Week 16 of the placebo-controlled phase
Percentage of Participants With a Scalp Physician Global Assessment (ScPGA) Response at Week 16 Among Participants With Baseline scPGA Score ≥ 2 at Week 16
The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an Investigator's assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation of the overall scalp.
An ScPGA response is defined as and ScPGA score clear (0) or almost clear (1) with at least a 2-point reduction from baseline among participants with a baseline ScPGA score ≥ 2.
Measured: Baseline and Week 16 of the placebo-controlled phase
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
The DLQI is a 10 item questionnaire dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from 0 (not at all) to 3 (very much). 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), and if "No," then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being 0 (not at all), 1 (a little) and 2 (a lot).
Total scores have a possible range of 0 to 30, with 30 corresponding to the worst health-related quality of life, and 0 corresponding to the best score.
A negative change from baseline indicates an improvement in health-related quality of life scores.
Measured: Baseline and Week 16 of the placebo-controlled phase
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A TEAE is any AE that occurs following administration of study treatment.
Frequency of TEAEs was assessed as well as severity and treatment relatedness.
A TEAE was considered severe based on the Investigator's assessment. A TEAE could be severe if it was serious or non-serious, had symptoms causing discomfort or pain, requiring medical or surgical attention or intervention, interfered with activities of daily life and if drug therapy was required.
Measured: Placebo: Day 1 to Week 16; Apremilast Day 1 to a maximum of Week 32 (plus 4 week safety follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start11 Mar 2019
- Primary completion6 Mar 2020
- Study completion24 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721172
- Sponsor's protocol ID
- CC-10004-PSOR-022
- Other IDs
- U1111-1218-8372
- Acronym
- ADVANCE
- Status last verified
- May 2024
- First submitted
- 9 Oct 2018
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Publications
Stein Gold L, Papp K, Pariser D, Green L, Bhatia N, Sofen H, Albrecht L, Gooderham M, Chen M, Paris M, Wang Y, Callis Duffin K. Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2022 Jan;86(1):77-85. doi: 10.1016/j.jaad.2021.07.040. Epub 2021 Jul 31.
PubMed 34343599Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14.
PubMed 37316690Strober B, Lebwohl M, van de Kerkhof P, Gold LS, Merola JF, Okubo Y, Gisondi P, Zhou Z, Chaudhari S, Deignan C, Mrowietz U. Efficacy of Apremilast in Patients with Psoriasis with Limited Skin Involvement, Including High-Impact Site Involvement: A Pooled Analysis of Six Trials. Dermatol Ther (Heidelb). 2026 Oct 2. doi: 10.1007/s13555-026-01921-9. Online ahead of print.
PubMed 42825996
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03721172
- Acronym / sponsor ID
- ADVANCE / CC-10004-PSOR-022
- Conditions
- Psoriasis
- Keywords
- Phase 3, Double-Blind, Efficacy, Safety, Apremilast, Otezla, CC-10004, Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 595 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Posted 17 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis.
Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.
Detailed description
The study will consist of four phases:
- Screening Phase - up to 35 days
- Double-blind Placebo-controlled Phase - Weeks 0 to 16
- Subjects will be randomly assigned to either apremilast 30 mg tablets orally BID or placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID.
- Apremilast Extension Phase - Weeks 16 to 32
- All subjects will be switched to (or continue with) apremilast 30 mg BID. All subjects will maintain this dosing through Week 32.
- Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue the study early.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo-controlled Phase: | Experimental | Other: PlaceboParticipants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). |
| Placebo-controlled Phase: Apremilast 30 mg | Experimental | Drug: ApremilastParticipants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). |
| Extension Phase: Apremilast 30 mg | Experimental | Drug: ApremilastEligible participants who completed the placebocontrolled phase entered the extension phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF).
- Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
- Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline.
- Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.
- Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
Key exclusion criteria (9 listed)
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subjects has any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- 2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB.
- 4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
- 5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApremilastApremilast, oral, twice daily | Drug | Extension Phase: Apremilast 30 mg, Placebo-controlled Phase: Apremilast 30 mg |
| PlaceboPlacebo, oral, twice daily | Other | Placebo-controlled Phase: |
Primary outcome
Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase
Time frame: Baseline and Week 16 of the placebo-controlled phase
The sPGA is a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 =severe. Scores incorporate an assessment by the Investigator of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation. An sPGA response is defined as sPGA score of clear (0) or almost clear (1) and with at least a 2-point reduction from baseline at Week 16.
8 secondary outcomes
Percentage of Participants With a ≥ 75 Percent (%) Improvement From Baseline in Affected Body Surface Area (BSA) at Week 16
Time frame: Baseline and Week 16 of the placebo-controlled phase
Change From Baseline in Percentage of Affected BSA at Week 16
Time frame: Baseline and Week 16 of the placebo-controlled phase
Change From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 16
Time frame: Baseline and Week 16 of the placebo-controlled phase
Percentage of Participants Who Achieved BSA ≤ 3% for Participants With Baseline Affected BSA > 3% at Week 16
Time frame: Baseline and Week 16 of the placebo-controlled phase
Percentage of Participants With ≥ 4-point Reduction From Baseline in Whole Body Itch Numeric Rating Scale (NRS) Score at Week 16 Who Had Baseline Whole Body Itch NRS ≥ 4
Time frame: Baseline and Week 16 of the placebo-controlled phase
Percentage of Participants With a Scalp Physician Global Assessment (ScPGA) Response at Week 16 Among Participants With Baseline scPGA Score ≥ 2 at Week 16
Time frame: Baseline and Week 16 of the placebo-controlled phase
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
Time frame: Baseline and Week 16 of the placebo-controlled phase
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Placebo: Day 1 to Week 16; Apremilast Day 1 to a maximum of Week 32 (plus 4 week safety follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34343599Stein Gold L, Papp K, Pariser D, Green L, Bhatia N, Sofen H, Albrecht L, Gooderham M, Chen M, Paris M, Wang Y, Callis Duffin K. Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2022 Jan;86(1):77-85. doi: 10.1016/j.jaad.2021.07.040. Epub 2021 Jul 31.
- Background: PubMed 37316690Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14.
- Derived from this study: PubMed 42825996Strober B, Lebwohl M, van de Kerkhof P, Gold LS, Merola JF, Okubo Y, Gisondi P, Zhou Z, Chaudhari S, Deignan C, Mrowietz U. Efficacy of Apremilast in Patients with Psoriasis with Limited Skin Involvement, Including High-Impact Site Involvement: A Pooled Analysis of Six Trials. Dermatol Ther (Heidelb). 2026 Oct 2. doi: 10.1007/s13555-026-01921-9. Online ahead of print.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
64 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apremilast in people with Psoriasis, run by Amgen at 64 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase (time frame: Baseline and Week 16 of the placebo-controlled phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03721172, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.