Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1218-8372 | Registry Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo-controlled Phase: | Experimental | Participants 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 | Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | Apremilast, oral, twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 16 of the placebo-controlled phase |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin & Beauty Dermatology Center | Birmingham | Alabama | 35205 | United States | ||
| Johnson Dermatology Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34343599 | Background | 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. | |
| 37316690 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Participants were randomized in a 1:1 ratio to receive either apremilast or matched placebo for the first 16 weeks (placebo-controlled phase) of the study. At Week 16, eligible participants may have continued on active treatment by entering a 16 week extension phase (apremilast extension phase), total = 32 weeks.
Participants were enrolled at 61 research centers in the United States and Canada from March 2019 to July 2020.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo-controlled Phase: Placebo | Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). |
| FG001 | Placebo-controlled Phase: Apremilast 30 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo-controlled Phase |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2018 | Apr 26, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Placebo, oral, twice daily |
|
| 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. | 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. | 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). | 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. | 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. | 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. | 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. | Placebo: Day 1 to Week 16; Apremilast Day 1 to a maximum of Week 32 (plus 4 week safety follow-up) |
| Fort Smith |
| Arkansas |
| 72916 |
| United States |
| Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology | Rogers | Arkansas | 72758 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| TCR Medical Corporation | San Diego | California | 92123 | United States |
| University of California San Francisco Psoriasis and Skin Treatment Center | San Francisco | California | 94118 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| University of Colorado Hospital - Dermatology Clinic | Aurora | Colorado | 80045 | United States |
| Total Vein and Skin, LLC | Boynton Beach | Florida | 33437 | United States |
| Florida Academic Centers Research and Education | Coral Gables | Florida | 33134 | United States |
| International Dermatology Research | Miami | Florida | 33144 | United States |
| Center for Clinical and Cosmetic Research | Miami | Florida | 33180 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| University of South Florida - Carol and Frank Morsani Center for Advanced Health Care | Tampa | Florida | 33612 | United States |
| Atlanta Dermatology, Vein and Research Center, PC | Alpharetta | Georgia | 30022 | United States |
| Medical Dermatology Specialists, Inc. - Advanced Medical Research | Atlanta | Georgia | 30328 | United States |
| MedaPhase INC | Newnan | Georgia | 30263 | United States |
| Gwinnett Clinical Research Center, Inc. | Snellville | Georgia | 30078 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | United States |
| Clinical Trials Management LLC | Metairie | Louisiana | 70006 | United States |
| Derm Associates | Rockville | Maryland | 20850 | United States |
| Lawrence Green, MD, LLC | Rockville | Maryland | 20850 | United States |
| ActivMed Practices & Research Inc | Beverly | Massachusetts | 01915 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2517 | United States |
| Henry Ford Medical Center - New Center One | Detroit | Michigan | 48202 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Central Dermatology | St Louis | Missouri | 63117 | United States |
| JDR Dermatology Research, LLC | Las Vegas | Nevada | 89148 | United States |
| Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10003 | United States |
| Albert Einstein College of Medicine - Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27104 | United States |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Wright State Physicians | Fairborn | Ohio | 45324 | United States |
| Temple University - Lewis Katz School of Medicine | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | United States |
| Clinical Research Center of the Carolinas | Charleston | South Carolina | 29407 | United States |
| Austin Institute for Clinical Research | Pflugerville | Texas | 78660 | United States |
| Center for Clinical Studies | Webster | Texas | 77598 | United States |
| University of Utah MidValley Dermatology | Murray | Utah | 84107 | United States |
| Virginia Clinical Research Inc | Norfolk | Virginia | 23502 | United States |
| Dermatology Center for Skin Health | Morgantown | West Virginia | 26505 | United States |
| Institute for Skin Advancement | Calgary | Alberta | T3A 2N1 | Canada |
| Stratica Medical | Edmonton | Alberta | T5K 1X3 | Canada |
| Chih-Ho Hong Medical, Inc. | Surrey | British Columbia | V3R 6A7 | Canada |
| Enverus Medical Research | Surrey | British Columbia | V3V 0C6 | Canada |
| Winnipeg Clinic Dermatology Research | Winnipeg | Manitoba | R3CON2 | Canada |
| SkinWise Dermatology | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Brunswick Dermatology Centre | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Karma Clinical Trials | St. John's | Newfoundland and Labrador | A1A 4Y3 | Canada |
| SimcoDerm Medical and Surgical Dermatology Center | Barrie | Ontario | L4M 7G1 | Canada |
| Guelph Dermatology Research | Guelph | Ontario | N1L 0B7 | Canada |
| DermEffects | London | Ontario | N6H 5L5 | Canada |
| Lynderm Research | Markham | Ontario | L3P 1X2 | Canada |
| North Bay Dermatology Centre | North Bay | Ontario | P1B 3Z7 | Canada |
| Skin Center for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| Toronto Research Centre | Toronto | Ontario | M3H 5Y8 | Canada |
| Sameh Hanna Medicine Professional Corporation DBA Dermatology on Bloor | Toronto | Ontario | M4W 2N2 | Canada |
| K. Papp Clinical Research | Waterloo | Ontario | N2J 1C4 | Canada |
| Windsor Clinical Research Inc. | Windsor | Ontario | N8W 5L7 | Canada |
| Dr Isabelle Delorme inc | Drummondville | Quebec | J2B 5L4 | Canada |
| Dre Angelique Gagne-Henley M.D. Inc. | Saint-Jérôme | Quebec | J7Z 7E2 | Canada |
| Skinsense Medical Research | Saskatoon | Saskatchewan | S7K 0H6 | Canada |
| Background |
| Mease 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. |
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
| FG002 | Extension Phase: Apremilast 30 mg | Eligible participants who completed the placebo-controlled 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). |
| Received at Least 1 Dose of Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Apremilast Extension Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo-controlled Phase: Placebo | Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). |
| BG001 | Placebo-controlled Phase: Apremilast 30 mg | Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Static Physician Global Assessment (sPGA) Score | 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. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-treat (ITT) analysis set: all participants who were randomized into the placebo controlled phase. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and Week 16 of the placebo-controlled phase |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | ITT analysis set: all participants who were randomized in the placebo-controlled phase. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and Week 16 of the placebo-controlled phase |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT analysis set (all participants who were randomized) in the placebo-controlled phase with a baseline value and at least one post-baseline value at Week 16 | Posted | Least Squares Mean | Standard Error | Percentage change of affected BSA | Baseline and Week 16 of the placebo-controlled phase |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT analysis set (all participants who were randomized) in the placebo-controlled phase with a baseline value and at least one post-baseline value at Week 16 | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and Week 16 of the placebo-controlled phase |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | ITT analysis set (all participants who were randomized) in the placebo-controlled phase with baseline BSA > 3%. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and Week 16 of the placebo-controlled phase |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT analysis set (all participants who were randomized) in the placebo-controlled phase with baseline whole body itch NRS score ≥ 4. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and Week 16 of the placebo-controlled phase |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT analysis set (all participants who were randomized) in the placebo-controlled phase with baseline ScPGA Score ≥ 2). | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and Week 16 of the placebo-controlled phase |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT analysis set (all participants who were randomized) in the placebo-controlled phase with a baseline value and at least one post-baseline value at Week 16 | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and Week 16 of the placebo-controlled phase |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety analysis set: all randomized participants who received at least 1 dose of treatment. One participant randomized to the placebo group received apremilast and was therefore allocated to the apremilast group for the safety analysis. | Posted | Count of Participants | Participants | Placebo: Day 1 to Week 16; Apremilast Day 1 to a maximum of Week 32 (plus 4 week safety follow-up) |
|
Placebo: Day 1 to Week 16; Apremilast Day 1 to a maximum of Week 32 (plus 4 week safety follow-up)
The safety analysis set includes all randomized participants who received at least 1 dose of investigational product. One participant randomized to the placebo group received apremilast and was therefore allocated to the apremilast group for the safety analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo-controlled Phase: Placebo | Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). | 0 | 296 | 4 | 296 | 51 | 296 |
| EG001 | Placebo-controlled Phase: Apremilast 30 mg | Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). | 0 | 298 | 1 | 298 | 118 | 298 |
| EG002 | Apremalist: Placebo-controlled Phase and Extension Phase | All participants who received apremalist 30 mg as oral tablets BID in either the placebo-controlled phase (Week 0 to Week 16), the apremilast extension phase (Week 16 to Week 32), or both phases (Week 0 to Week 32). | 0 | 544 | 12 | 544 | 208 | 544 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Migraine without aura | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2020 | Apr 26, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D008224 | Lymphoma, Follicular |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C505730 | apremilast |
Not provided
Not provided
Not provided
| Non-compliance with study drug |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Other |
|
| Other (Related to COVID-19) |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 3 (moderate) |
|
|
|
|
|
|
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
|
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
| OG002 |
| Apremalist: Placebo-controlled Phase and Extension Phase |
All participants who received apremalist 30 mg as oral tablets BID in either the placebo-controlled phase (Week 0 to Week 16), the apremilast extension phase (Week 16 to Week 32), or both phases (Week 0 to Week 32) |
|
|