A Phase 3 interventional study of Apremilast and Topical Therapy in Plaque Psoriasis, sponsored by Amgen. Completed at 56 sites in 2 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-01-20.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
The primary objective of the study is to assess the efficacy and safety of the combination of apremilast plus topical therapies for the treatment of adults with plaque psoriasis who have not achieved an adequate response with topicals alone.
Participants will be enrolled at 28 sites in Japan. The study consists of 4 phases: a screening phase (4 weeks), an open-label combination therapy phase (16 weeks), an open-label combination therapy phase with optional topical reduction (16 weeks), and a post-treatment observational follow-up phase (4 weeks).
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 152 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Amgen is the lead sponsor of 1,016 studies on the registry; 50 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must satisfy the following criteria to be enrolled in the study:
Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories.
(NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device; tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
After a 5-day titration, participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16 participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.
Drug: Apremilast · Drug: Topical Therapy
Tablets for oral administration
Also known as: CC-10004, Otezla®
Participants continued to use their existing topical treatment for psoriasis for the first 16 weeks. After 16 weeks, participants could decrease the use of topical therapy at their discretion under the direction of their physician.
Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16
The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear; 1. = Almost Clear; 2. = Mild; 3. = Moderate; 4. = Severe. The percentage of participants with a sPGA response was estimated using a multiple imputation method from 100 imputed data sets.
Time frame: Week 16
Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 32
The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear; 1. = Almost Clear; 2. = Mild; 3. = Moderate; 4. = Severe.
Time frame: Week 32
Percentage of Participants Who Achieved a Scalp Physicians Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 and 32
The ScPGA assesses scalp involvement of psoriasis based on scalp plaque elevation, scaling, and erythema. The 5-point ScPGA scale ranges from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe).
Time frame: Weeks 16 and 32
Change From Baseline in Percentage of BSA Affected by Psoriasis at Weeks 16 and 32
The overall body surface area affected by psoriasis was estimated based on the palm area of the participant's hand, which equates to approximately 1% of total body surface area. BSA affected by psoriasis is expressed as a percentage of total body surface area. A negative change from baseline indicates improvement.
Time frame: Baseline and weeks 16 and 32
Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 2, 16, and 32
Participants were asked to indicate how much itch they have had due to psoriasis in the past week by placing a vertical stroke on a 100 mm line on which the left-hand boundary (0 mm) represented no itch, and the right-hand boundary (100 mm) represented worst itch imaginable. The distance from the mark to the left-hand boundary was recorded. A negative change from baseline indicates improvement.
Time frame: Baseline and weeks 2, 16, and 32
Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32
Shiratori's Pruritus Severity Score is a pruritus (itchiness) severity assessment tool used in Japan. Daytime and nighttime pruritus were evaluated and scored separately. Daytime pruritus was rated on a five-grade scale: 0 (absent), 1 (endurable without scratching; minimal), 2 (subsides with slight scratching; mild), 3 (subsides with considerable scratching; moderate), or 4 (not subsiding with scratching, which prompts repeated scratching; severe). Nighttime pruritus was rated on a five-grade scale: 0 (absent), 1 (slight itching at bedtime but not causing intentional scratching; no difficulty sleeping because of pruritus), 2 (slight itching that subsides with scratching; no difficulty sleeping because of pruritus), 3 (difficulty sleeping because of pruritus that resolves with scratching; unconscious scratching occurs during sleep), or 4 (severe difficulty sleeping due to pruritus; frequent scratching that worsens pruritus). A negative change from baseline indicates improvement.
Time frame: Baseline and weeks 2, 16, and 32
Percentage of Participants Who Achieved a ≥ 50% Reduction From Baseline in NAPSI Score (NAPSI-50) at Weeks 16 and 32 Among Participants With NAPSI ≥ 1 at Baseline
One target thumb nail or fingernail representing the worst nail psoriasis involvement was selected for assessment at Baseline. The nail matrix was assessed for presence of any of the nail matrix features (pitting, leukonychia red spots in the lunula, crumbling) graded on a scale of 0 (none) to 4 (present in all 4 quadrants). The nail bed was assessed for the presence of any nail bed features (onycholysis, splinter hemorrhages, subungual hyperkeratosis, "oil drop" (salmon patch dyschroma) on a scale from 0 (none) to 4 (present in all quadrants). The sum of the nail matrix and nail bed scores is the total score and ranges from 0 to 8 (worst).
Time frame: Weeks 16 and 32
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 16 and 32
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much), except for Question 7, which first asks whether the participant's skin prevented them from working or studying (Yes (score = 3) or No (score = 0), then If "No", the participant is asked how much their skin was a problem at work or studying over the last week, with responses from 0 (not at all), 1 (a little), or 2 (a lot). The DLQI total score ranges from 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A negative change from baseline indicates improvement.
Time frame: Baseline and weeks 16 and 32
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 16 and 32
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. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. A negative change from baseline indicates improvement.
Time frame: Baseline and weeks 16 and 32
Percentage of Participants Who Achieved ≥ 75% Reduction From Baseline in PASI Score (PASI-75)
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. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
Time frame: Weeks 16 and 32
Percentage of Participants Who Achieved ≥ 50% Reduction From Baseline in PASI Score (PASI-50)
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. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
Time frame: Weeks 16 and 32
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores
The Treatment Satisfaction Questionnaire for Medication (TSQM) version II is a self-administered instrument to understand a participant's satisfaction on current therapy. The TSQM comprises 11 items across 4 domains focusing on effectiveness (Item 1 and 2), side effects (Item 4 to 6), convenience (Item 7 to 9), and global satisfaction (Item 10 and 11). With the exception of Item 3 (experience any side effects; yes or no), all items have five or seven responses. Item scores are summed to give four domain scores, which are in turn transformed to a scale from 0 (extremely dissatisfied) to 100 (extremely satisfied).
Time frame: Baseline and weeks 16 and 32
Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Score ≥ 1 at Weeks 16 and 32
The Patient Benefit Index (PBI) is used to assess patient-relevant benefits of psoriasis treatment as a function of the most important needs identified by the participant before the start of treatment. Participants were asked to assess the benefits of treatment by completing the Patient Benefit Questionnaire (PBQ), which consists of 25 treatment goal statements scored from 0 (not at all) to 4 (very). The PBI is calculated for each participant by weighing the achievement values of each statement by their importance to the individual patient as assessed prior to the start of treatment. The PBI ranges from 0 (no benefit) to 4 (maximum benefit).
Time frame: Weeks 16 and 32
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
The Investigator assessed the severity/intensity of each adverse event as: Mild (asymptomatic or mild symptoms; intervention not indicated; activities of daily life (ADLs) minimally or not affected); Moderate (symptom(s) cause moderate discomfort; local or noninvasive intervention indicated; more than minimal interference with ADLs but able to carry out daily social and functional activities; drug therapy may be required); Severe (symptoms causing severe discomfort/pain; symptoms requiring medical/surgical attention/intervention; interference with ADLs including inability to perform daily social and functional activities; drug therapy required). A serious adverse event is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event.
Time frame: From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
This study was conducted at 28 centers in Japan.
| Milestone | Apremilast |
|---|---|
| Started | 152 |
| Received study drug | 152 |
| Completed | 140 |
| Not completed | 12 |
| Withdrew: Adverse event | 6 |
| Withdrew: Withdrawal by subject | 6 |
| Milestone | Apremilast |
|---|---|
| Started | 140 |
| Completed | 136 |
| Not completed | 4 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 3 |
The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear; 1. = Almost Clear; 2. = Mild; 3. = Moderate; 4. = Severe. The percentage of participants with a sPGA response was estimated using a multiple imputation method from 100 imputed data sets.
| percentage of participants | Apremilast |
|---|---|
| Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16 | 43.7 (35.72 to 51.66) |
The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear; 1. = Almost Clear; 2. = Mild; 3. = Moderate; 4. = Severe.
| percentage of participants | Apremilast |
|---|---|
| Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 32 | 40.8 (32.98 to 48.60) |
The ScPGA assesses scalp involvement of psoriasis based on scalp plaque elevation, scaling, and erythema. The 5-point ScPGA scale ranges from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe).
| percentage of participants | Apremilast |
|---|---|
| Week 16 | 52.3 (43.69 to 61.00) |
| Week 32 | 50.8 (42.12 to 59.44) |
The overall body surface area affected by psoriasis was estimated based on the palm area of the participant's hand, which equates to approximately 1% of total body surface area. BSA affected by psoriasis is expressed as a percentage of total body surface area. A negative change from baseline indicates improvement.
| percent BSA | Apremilast |
|---|---|
| Week 16 | -7.86 ± 8.755 |
| Week 32 | -8.32 ± 9.478 |
Participants were asked to indicate how much itch they have had due to psoriasis in the past week by placing a vertical stroke on a 100 mm line on which the left-hand boundary (0 mm) represented no itch, and the right-hand boundary (100 mm) represented worst itch imaginable. The distance from the mark to the left-hand boundary was recorded. A negative change from baseline indicates improvement.
| percent change | Apremilast |
|---|---|
| Week 2 | -36.96 ± 46.474 |
| Week 16 | -28.05 ± 118.300 |
| Week 32 | -25.29 ± 122.113 |
Shiratori's Pruritus Severity Score is a pruritus (itchiness) severity assessment tool used in Japan. Daytime and nighttime pruritus were evaluated and scored separately. Daytime pruritus was rated on a five-grade scale: 0 (absent), 1 (endurable without scratching; minimal), 2 (subsides with slight scratching; mild), 3 (subsides with considerable scratching; moderate), or 4 (not subsiding with scratching, which prompts repeated scratching; severe). Nighttime pruritus was rated on a five-grade scale: 0 (absent), 1 (slight itching at bedtime but not causing intentional scratching; no difficulty sleeping because of pruritus), 2 (slight itching that subsides with scratching; no difficulty sleeping because of pruritus), 3 (difficulty sleeping because of pruritus that resolves with scratching; unconscious scratching occurs during sleep), or 4 (severe difficulty sleeping due to pruritus; frequent scratching that worsens pruritus). A negative change from baseline indicates improvement.
| units on a scale | Apremilast |
|---|---|
| Daytime: Week 2 | -0.5 ± 0.77 |
| Daytime: Week 16 | -0.7 ± 0.95 |
| Daytime: Week 32 | -0.7 ± 0.95 |
| Nighttime: Week 2 | -0.4 ± 0.85 |
| Nighttime: Week 16 | -0.7 ± 0.86 |
| Nighttime: Week 32 | -0.7 ± 0.91 |
One target thumb nail or fingernail representing the worst nail psoriasis involvement was selected for assessment at Baseline. The nail matrix was assessed for presence of any of the nail matrix features (pitting, leukonychia red spots in the lunula, crumbling) graded on a scale of 0 (none) to 4 (present in all 4 quadrants). The nail bed was assessed for the presence of any nail bed features (onycholysis, splinter hemorrhages, subungual hyperkeratosis, "oil drop" (salmon patch dyschroma) on a scale from 0 (none) to 4 (present in all quadrants). The sum of the nail matrix and nail bed scores is the total score and ranges from 0 to 8 (worst).
| percentage of participants | Apremilast |
|---|---|
| Week 16 | 44.7 (33.56 to 55.92) |
| Week 32 | 57.9 (46.79 to 68.99) |
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much), except for Question 7, which first asks whether the participant's skin prevented them from working or studying (Yes (score = 3) or No (score = 0), then If "No", the participant is asked how much their skin was a problem at work or studying over the last week, with responses from 0 (not at all), 1 (a little), or 2 (a lot). The DLQI total score ranges from 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A negative change from baseline indicates improvement.
| scores on a scale | Apremilast |
|---|---|
| Week 16 | -2.2 ± 2.96 |
| Week 32 | -2.3 ± 2.97 |
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. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. A negative change from baseline indicates improvement.
| percent change | Apremilast |
|---|---|
| Week 16 | -69.61 ± 22.896 |
| Week 32 | -69.48 ± 25.421 |
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. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
| percentage of participants | Apremilast |
|---|---|
| Week 16 | 43.4 (35.54 to 51.30) |
| Week 32 | 46.7 (38.78 to 54.64) |
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. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
| percentage of participants | Apremilast |
|---|---|
| Week 16 | 79.6 (73.20 to 86.01) |
| Week 32 | 75.0 (68.12 to 81.88) |
The Treatment Satisfaction Questionnaire for Medication (TSQM) version II is a self-administered instrument to understand a participant's satisfaction on current therapy. The TSQM comprises 11 items across 4 domains focusing on effectiveness (Item 1 and 2), side effects (Item 4 to 6), convenience (Item 7 to 9), and global satisfaction (Item 10 and 11). With the exception of Item 3 (experience any side effects; yes or no), all items have five or seven responses. Item scores are summed to give four domain scores, which are in turn transformed to a scale from 0 (extremely dissatisfied) to 100 (extremely satisfied).
| scores on a scale | Apremilast |
|---|---|
| Effectiveness: Baseline | 52.25 ± 17.553 |
| Effectiveness: Week 16 | 67.41 ± 21.176 |
| Effectiveness: Week 32 | 68.93 ± 19.067 |
| Side Effects: Baseline | 97.37 ± 10.078 |
| Side Effects: Week 16 | 90.40 ± 17.714 |
| Side Effects: Week 32 | 93.21 ± 14.947 |
| Convenience: Baseline | 56.43 ± 16.735 |
| Convenience: Week 16 | 70.34 ± 17.201 |
| Convenience: Week 32 | 70.48 ± 16.527 |
| Global Satisfaction: Baseline | 55.43 ± 18.554 |
| Global Satisfaction: Week 16 | 71.21 ± 18.241 |
| Global Satisfaction: Week 32 | 70.71 ± 18.660 |
The Patient Benefit Index (PBI) is used to assess patient-relevant benefits of psoriasis treatment as a function of the most important needs identified by the participant before the start of treatment. Participants were asked to assess the benefits of treatment by completing the Patient Benefit Questionnaire (PBQ), which consists of 25 treatment goal statements scored from 0 (not at all) to 4 (very). The PBI is calculated for each participant by weighing the achievement values of each statement by their importance to the individual patient as assessed prior to the start of treatment. The PBI ranges from 0 (no benefit) to 4 (maximum benefit).
| percentage of participants | Apremilast |
|---|---|
| Week 16 | 91.4 (87.00 to 95.89) |
| Week 32 | 88.2 (83.02 to 93.29) |
The Investigator assessed the severity/intensity of each adverse event as: Mild (asymptomatic or mild symptoms; intervention not indicated; activities of daily life (ADLs) minimally or not affected); Moderate (symptom(s) cause moderate discomfort; local or noninvasive intervention indicated; more than minimal interference with ADLs but able to carry out daily social and functional activities; drug therapy may be required); Severe (symptoms causing severe discomfort/pain; symptoms requiring medical/surgical attention/intervention; interference with ADLs including inability to perform daily social and functional activities; drug therapy required). A serious adverse event is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event.
| Participants | Apremilast |
|---|---|
| Any treatment-emergent adverse event | 115 |
| Drug-related TEAE | 88 |
| Severe TEAE | 4 |
| Serious TEAE | 4 |
| Severe drug-related TEAE | 1 |
| Serious drug-related TEAE | 1 |
| TEAE leading to drug interruption | 3 |
| TEAE leading to drug withdrawal | 7 |
| TEAE leading to death | 0 |
Collected over From first dose of study drug until at least 28 days after last dose; up to 36 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Apremilast 30 mg | 0/152 (0%) | 4/152 (2.6%) | 84/152 (55.3%) |
| Event | Apremilast 30 mg |
|---|---|
| Deafness unilateralEar and labyrinth disorders | 1/152 |
| GastroenteritisInfections and infestations | 1/152 |
| Thoracic vertebral fractureInjury, poisoning and procedural complications | 1/152 |
| Blood creatine phosphokinase increasedInvestigations | 1/152 |
| DepressionPsychiatric disorders | 1/152 |
| Event | Apremilast 30 mg |
|---|---|
| DiarrhoeaGastrointestinal disorders | 29/152 |
| NauseaGastrointestinal disorders | 29/152 |
| NasopharyngitisInfections and infestations | 28/152 |
| Faeces softGastrointestinal disorders | 20/152 |
| HeadacheNervous system disorders | 20/152 |
All enrolled participants
| Age, Continuous(years) | Apremilast |
|---|---|
| Mean | 48.0 ± 11.90 |
| Age, Customized(Participants) | Apremilast |
|---|---|
| < 65 years | 137 |
| ≥ 65 to < 75 years | 14 |
| ≥ 75 years | 1 |
| Sex: Female, Male(Participants) | Apremilast |
|---|---|
| Female | 51 |
| Male | 101 |
| Race/Ethnicity, Customized(Participants) | Apremilast |
|---|---|
| Asian | 152 |
| Duration of Plaque Psoriasis(years) | Apremilast |
|---|---|
| Mean | 11.94 ± 10.629 |
| Body Surface Area (BSA) Affected by Psoriasis(percentage of total body surface area) | Apremilast |
|---|---|
| Mean | 13.40 ± 11.491 |
| Static Physician's Global Assessment (sPGA) Score(Participants) | Apremilast |
|---|---|
| 0 (Clear) | 0 |
| 1 (Almost Clear) | 0 |
| 2 (Mild) | 51 |
| 3 (Moderate) | 101 |
| 4 (Severe) | 0 |
| Scalp Physicians Global Assessment (ScPGA)(Participants) | Apremilast |
|---|---|
| 0 (Clear) | 17 |
| 1 (Almost Clear) | 7 |
| 2 (Mild) | 63 |
| 3 (Moderate) | 63 |
| 4 (Severe) | 2 |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting information: Study protocol, Sap, Icf, Csr
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