Psoriasis
Conditions
Keywords
Palmo-Plantar Pustolosis
Brief summary
The main purpose of this study is to demonstrate the improvement in the skin condition rate of patients receiving alitretinoin compared to patients receiving placebo.
Detailed description
Palmo-plantar pustulosis (PPP) is an inflammatory skin disease affecting palms and soles. The disease is considered as a sub-form of psoriasis and presents with sterile pustules of the palms and the soles. This study investigates the efficacy of alitretinoin in patients who have not responded to topical drugs (e.g., steroid creams), who are suffering for at least 6 month from the condition and whose disease severity is confirmed by a score.
Interventions
DRUGalitretinoin
to receive verum (20 patients)
DRUGPlacebo
to receive placebo (10 patients)
Sponsors
Basilea Pharmaceutica
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A female subject is eligible to participate if she is of: * Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea and a follicle stimulating hormone concentration of ≥40 international units (IU)/L. * Child-bearing potential with negative pregnancy test as determined by human chorionic gonadotropin (hCG) test at screening or prior to dosing and either 1) agrees to use a medically acceptable contraception method for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point and continue contraception until the end of the study, or 2) has only same-sex partners, when this is her preferred and usual lifestyle. 2. Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed. 3. Male or female aged at least 18 years at time of consent and at time of first dose. 4. Have PPP for at least 6 months, with or without psoriasis lesions on other areas of the skin 5. A PPPASI score of at least 8 with involvement of at least 10% of the palms and/or the soles 6. Refractory to standard topical corticosteroid therapy
Exclusion criteria
1. Unable to comply with the requirement of the study 2. Female subjects who are pregnant or who plan to become pregnant or who are breast feeding 3. Subjects whose disease is adequately controlled by standard non-medicated therapy (skin moisturizing and protection) 4. Known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil 5. Treated with any of the following treatments 4 weeks before the start of study treatment: * systemic drugs: corticosteroids, immunosuppressants, methotrexate * phototherapy: ultraviolet B light therapy \[UVB\], psoralen with ultraviolet A combination therapy \[PUVA\], Grenz rays, X-rays 6. Treated with biologic treatments within 6 weeks prior to start of study treatment. 7. Abnormal hematology 8. Treated with any systemic or topical retinoids within 3 months or 1 month, respectively, before start of study treatment 9. Treated with high-potency topical corticosteroids within 2 weeks before the start of study treatment 10. Severe generalized pustular psoriasis 11. A skin condition of palms and/or soles that interferes with the diagnosis of PPP by the investigator 12. Any condition that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study. 13. Hepatic insufficiency, severe renal failure, uncontrolled hypercholesterolemia as characterized by: * AST/ ALT \>2.5 x upper limit of normal (ULN) * Creatinine clearance \<60 mL/min (calculated, Cockcroft-Gault) * Fasting triglyceridemia \>1.5 x upper limit of normal (ULN) * Fasting cholesterol \>1.5 x ULN * Fasting low-density lipoprotein (LDL) cholesterol \>1.5x ULN 14. Subjects with hypothyroidism as indicated by thyroid stimulating hormone (TSH) above ULN and thyroxine (T4) test below LLN or hypervitaminosis A 15. Subjects with unstable cardiac disease or poorly controlled cardiovascular risk factors, for example: * Acute coronary syndrome or coronary revascularization (percutaneous coronary intervention \[PCI\], coronary artery bypass graft \[CABG\]) within 3 months before start of study treatment * Poorly controlled diabetes mellitus (HbA1c \>8.5%) 16. Systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg at the screening examination 17. Subjects receiving drugs with a potential for drug-drug interaction, such as systemic tetracyclines, ketoconazole, or St. John's Wort within 1 week, or receiving systemic itraconazole within 2 weeks, before start of study treatment 18. Subjects included in the study of an investigational drug within 2 months before start of study treatment (3 months for biologics) 19. Subjects with a score of 20 or more on the Center for Epidemiologic Studies Depression scale (CES-D), or with active major psychiatric disorder (eg, Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Disorder \[I or II\], or schizophrenia) 20. Subjects who score a 4 or 5 for the previous 30 days on the Columbia Suicide Severity Rating Scale (CSSRS) at Screening or Baseline 21. Subjects who have made a suicide attempt within the 6 months preceding the Screening or Baseline visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Palmo-plantar Pustulosis Psoriasis Area and Severity Index (PPPASI) Score at the End of Treatment (EOT) (Week 24) or at the Last Assessment | Baseline and EOT (Week 24) or the last assessment | The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis \[PPP\]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value. |
| Number of Participants With PPPASI 50 Response and PPPASI 75 Response | From Baseline until EOT (Week 24) or the last assessment | The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis \[PPP\]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value. PPPASI 50 response and PPPASI 75 response are defined as a 50% and 75% decrease, respectively, in the PPPASI score from Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on the redness, thickness, and scaliness scores of plaques (0-4 each) for the head, upper extremities, trunk, and lower extremities and the area of psoriatic involvement score (0-6). The lowest possible mPASI score was zero and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values. |
| Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the EOT visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole. |
| Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the End of Treatment visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole. Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value. |
| Change From Baseline in the mPASI Score at EOT (Week 24) or at the Last Assessment | Baseline and EOT (Week 24) or the last assessment | Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on redness, thickness, and scaliness scores of plaques (0-4 each) for head, upper extremities, trunk, lower extremities and area of psoriatic involvement score (0-6). Lowest possible mPASI score was 0 and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values. Change from Baseline is defined as the value at EOT minus baseline value. |
| Number of Participants With mPASI 50 Response and mPASI 75 Response | From Baseline until EOT (Week 24) | Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). The fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated. mPASI 50 response and mPASI 75 response is defined as a 50% and 75% decrease, respectively, in the mPASI score from Baseline. |
| Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | Baseline, Week 12, and EOT (Week 24) | The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24). |
| Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24) | Baseline, Week 12, and EOT (Week 24) | The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24). Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value. |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment | From Baseline until safety follow up (Week 29) | An AE was any adverse change from the participant's Baseline (pre-treatment) clinical condition, including intercurrent illness, which occurred during the course of a clinical study after written informed consent had been given, whether considered related to treatment or not. The relationship of AEs to the study treatment was assessed as unrelated, remotely related, possibly related, and probably related. For an AE to be considered serious, it fell into one or more of the following categories: results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, and is a congenital abnormality or birth defect. |
| Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29) | Fasted lipid laboratory parameters included triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol. Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value. |
| Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24) and safety follow-up (Week 29) | Change from Baseline is defined as the value at the safety follow up visit minus baseline value. |
| Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | From Baseline until EOT (Week 24) | Laboratory parameters included triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, LDL/HDL ratio, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and amylase and lipase. The central laboratory classified a finding as either abnormal or normal. |
| Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29) | The CES-D scale is a short, self-report scale designed to measure depressive symptomatology in the general population. The CES-D consists of 20 questions. Participants were instructed to circle the number for each statement that best described how often they felt or behaved a particular way during the past week. The score was the sum of the weights of the 20 items. Responses range from 0 to 3 for each item (0=rarely or none of the time, 1=some or little of the time, 2=moderately or much of the time, 3=most or almost all the time). The CES-D score ranges from 0 to 60, with higher scores indicating greater depression. Participants with a CES-D score of 20 or higher were re-evaluated within 2 weeks. If a CES-D score of 20 or higher was confirmed on the second occasion, and if the score represents an increase over Baseline of 4 points or more, study treatment was interrupted and the participants were referred for psychiatric evaluation. |
| Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29) | The CES-D scale is a short, self-report scale designed to measure depressive symptomatology in the general population. The CES-D consists of 20 questions. Participants were instructed to circle the number for each statement that best described how often they felt or behaved a particular way during the past week. The score was the sum of the weights of the 20 items. Responses range from 0 to 3 for each item (0=rarely or none of the time, 1=some or little of the time, 2=moderately or much of the time, 3=most or almost all the time). The CES-D score ranges from 0 to 60, with higher scores indicating greater depression. Participants with a CES-D score of \>=20 were re-evaluated within 2 weeks. If a CES-D score of \>=20 was confirmed on the second occasion, and if the score represents an increase over BL of 4 points or more, study treatment was interrupted and the participants were referred for psychiatric evaluation. Change from BL is defined as the post-BL value minus the BL value. |
| Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24), and safety follow-up (Week 29) | The assessment of suicidality was conducted using the CSSRS, a brief questionnaire designed to assess severity and change in suicidality using a semi-structured interview to probe participant responses. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation. CSSRS scores were reported at Screening; Baseline; Week 4, 8, 12, 16, 20; EOT (Week 24);and safety follow-up (Week 29). |
| Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29) | The assessment of suicidality was conducted using the CSSRS, a brief questionnaire designed to assess severity and change in suicidality using a semi-structured interview to probe participant responses. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation. CSSRS scores were reported at Baseline; Week 4, 8, 12, 16, 20; EOT (Week 24); and safety follow-up (Week 29). Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value. |
| Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24) | Screening, Baseline, and EOT (Week 24) | SBP and DBP were assessed at Screening, Baseline, and EOT. |
| Mean Heart Rate (HR) at Baseline, Screening, and EOT (Week 24) | Screening, Baseline, and EOT (Week 24) | HR is defined as the rate at which the heart beats. |
| Mean Body Weight at Screening, Baseline ,and EOT (Week 24) | Screening, Baseline, and EOT (Week 24) | Body weight was measured at Screening, Baseline, and EOT. |
| Change From Baseline in SBP and DBP at EOT (Week 24) | Baseline and EOT (Week 24) | Change from Baseline is defined as the value at EOT minus the Baseline value. |
| Change From Baseline in Heart Rate at EOT (Week 24) | Baseline and EOT (Week 24) | HR is defined as the rate at which the heart beats. Change from Baseline is defined as the value at EOT minus the Baseline value. |
| Change From Baseline in Weight at EOT (Week 24) | Baseline and EOT (Week 24) | Change from Baseline is defined as the value at EOT minus the value at Baseline. |
| Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal | Baseline and EOT (Week 24) | A physical examination for each participant was performed at Baseline and at EOT (Week 24). The primary investigator classified physical status as either normal or abnormal. |
| Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); safety follow-up (Week 29) | Serum pregnancy tests were performed at each visit for females of childbearing potential. |
Countries
France, Germany, Netherlands, United Kingdom
Participant flow
Recruitment details
The study was conducted at 7 centers from 26 April 2011 to 16 April 2014, in male and female participants of Palmo-plantar pustulosis (PPP), aged \>= 18 years.
Pre-assignment details
The total study duration was 33 weeks, with a Screening Period of up to 4 weeks, followed by 24 weeks of treatment and a 5-week safety Follow-up Period. Participants who met eligibility criteria were randomized (2:1) to receive 30 milligrams (mg) alitretinoin or matching placebo, given orally as gelatin capsules, once daily (QD) for up to 24 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Matching Placebo Participants received matching placebo orally QD for up to 24 weeks. | 9 |
| Alitretinoin 30 mg Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks. | 24 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Lack of Efficacy | 2 | 4 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Refused Treatment/Did Not Coopera | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Matching Placebo | Alitretinoin 30 mg | Total |
|---|---|---|---|
| Age, Continuous | 49.00 Years STANDARD_DEVIATION 16.32 | 48.83 Years STANDARD_DEVIATION 14.94 | 48.88 Years STANDARD_DEVIATION 15.06 |
| Race/Ethnicity, Customized Black | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian/White | 8 Participants | 22 Participants | 30 Participants |
| Race/Ethnicity, Customized North African | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Oriental | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 5 Participants | 14 Participants | 19 Participants |
| Sex: Female, Male Male | 4 Participants | 10 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 9 | 16 / 24 |
| serious Total, serious adverse events | 0 / 9 | 1 / 24 |
Outcome results
Primary
Change From Baseline in the Palmo-plantar Pustulosis Psoriasis Area and Severity Index (PPPASI) Score at the End of Treatment (EOT) (Week 24) or at the Last Assessment
The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis \[PPP\]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value.
Time frame: Baseline and EOT (Week 24) or the last assessment
Population: Full Analysis Set : treated participants with \>=1 efficacy result after receiving study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Matching Placebo | Change From Baseline in the Palmo-plantar Pustulosis Psoriasis Area and Severity Index (PPPASI) Score at the End of Treatment (EOT) (Week 24) or at the Last Assessment | -44.6 Scores on a scale | Standard Deviation 45.9 |
| Alitretinoin 30 mg | Change From Baseline in the Palmo-plantar Pustulosis Psoriasis Area and Severity Index (PPPASI) Score at the End of Treatment (EOT) (Week 24) or at the Last Assessment | -45.2 Scores on a scale | Standard Deviation 32.8 |
p-value: 0.970595% CI: [-30.9738, 32.12]ANCOVA
Primary
Number of Participants With PPPASI 50 Response and PPPASI 75 Response
The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis \[PPP\]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value. PPPASI 50 response and PPPASI 75 response are defined as a 50% and 75% decrease, respectively, in the PPPASI score from Baseline.
Time frame: From Baseline until EOT (Week 24) or the last assessment
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo | Number of Participants With PPPASI 50 Response and PPPASI 75 Response | PPPASI 50 response | 6 Participants |
| Matching Placebo | Number of Participants With PPPASI 50 Response and PPPASI 75 Response | PPPASI 75 response | 3 Participants |
| Alitretinoin 30 mg | Number of Participants With PPPASI 50 Response and PPPASI 75 Response | PPPASI 50 response | 11 Participants |
| Alitretinoin 30 mg | Number of Participants With PPPASI 50 Response and PPPASI 75 Response | PPPASI 75 response | 5 Participants |
p-value: 0.4564Fisher Exact
p-value: 0.6595Fisher Exact
Secondary
Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)
The CES-D scale is a short, self-report scale designed to measure depressive symptomatology in the general population. The CES-D consists of 20 questions. Participants were instructed to circle the number for each statement that best described how often they felt or behaved a particular way during the past week. The score was the sum of the weights of the 20 items. Responses range from 0 to 3 for each item (0=rarely or none of the time, 1=some or little of the time, 2=moderately or much of the time, 3=most or almost all the time). The CES-D score ranges from 0 to 60, with higher scores indicating greater depression. Participants with a CES-D score of \>=20 were re-evaluated within 2 weeks. If a CES-D score of \>=20 was confirmed on the second occasion, and if the score represents an increase over BL of 4 points or more, study treatment was interrupted and the participants were referred for psychiatric evaluation. Change from BL is defined as the post-BL value minus the BL value.
Time frame: Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)
Population: Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 12, n=7, 17 | -1.0 Scores on a scale | Standard Deviation 2.3 |
| Matching Placebo | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 20, n=6, 14 | -1.8 Scores on a scale | Standard Deviation 3.6 |
| Matching Placebo | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 8, n=7, 20 | -2.3 Scores on a scale | Standard Deviation 2.4 |
| Matching Placebo | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | End of Treatment, n=8, 20 | -0.5 Scores on a scale | Standard Deviation 6.6 |
| Matching Placebo | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 16, n=6, 16 | -2.0 Scores on a scale | Standard Deviation 2.1 |
| Matching Placebo | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Safety follow-up, n=9, 22 | -2.6 Scores on a scale | Standard Deviation 3.9 |
| Matching Placebo | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 4, n=9, 20 | -2.0 Scores on a scale | Standard Deviation 2.5 |
| Alitretinoin 30 mg | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Safety follow-up, n=9, 22 | 0.1 Scores on a scale | Standard Deviation 3.4 |
| Alitretinoin 30 mg | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 4, n=9, 20 | -0.3 Scores on a scale | Standard Deviation 2.4 |
| Alitretinoin 30 mg | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 8, n=7, 20 | 0.7 Scores on a scale | Standard Deviation 7.5 |
| Alitretinoin 30 mg | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 12, n=7, 17 | 0.6 Scores on a scale | Standard Deviation 5.4 |
| Alitretinoin 30 mg | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 16, n=6, 16 | -0.8 Scores on a scale | Standard Deviation 4.7 |
| Alitretinoin 30 mg | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 20, n=6, 14 | 0.3 Scores on a scale | Standard Deviation 4.7 |
| Alitretinoin 30 mg | Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | End of Treatment, n=8, 20 | -0.6 Scores on a scale | Standard Deviation 4.7 |
Secondary
Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24)
The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the End of Treatment visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole. Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.
Time frame: Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)
Population: Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | Week 4, n=9, 20 | -11.1 Pustule count | Standard Deviation 58.4 |
| Matching Placebo | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | Week 8, n=7, 20 | -7.9 Pustule count | Standard Deviation 51.5 |
| Matching Placebo | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | Week 12, n=7, 17 | -7.1 Pustule count | Standard Deviation 75.5 |
| Matching Placebo | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | Week 16, n=6, 16 | -55.2 Pustule count | Standard Deviation 56.5 |
| Matching Placebo | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | Week 20, n=6, 14 | -46.2 Pustule count | Standard Deviation 37.8 |
| Matching Placebo | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | End of Treatment, n=8, 20 | -31.3 Pustule count | Standard Deviation 79.4 |
| Alitretinoin 30 mg | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | Week 20, n=6, 14 | -65.1 Pustule count | Standard Deviation 106.4 |
| Alitretinoin 30 mg | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | Week 4, n=9, 20 | -75.3 Pustule count | Standard Deviation 113.2 |
| Alitretinoin 30 mg | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | Week 16, n=6, 16 | -75.6 Pustule count | Standard Deviation 113 |
| Alitretinoin 30 mg | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | Week 8, n=7, 20 | -75.9 Pustule count | Standard Deviation 124.4 |
| Alitretinoin 30 mg | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | End of Treatment, n=8, 20 | -82.1 Pustule count | Standard Deviation 121.3 |
| Alitretinoin 30 mg | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | Week 12, n=7, 17 | -74.2 Pustule count | Standard Deviation 111.7 |
p-value: 0.51Wilcoxon test: Exact Test
Secondary
Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29)
Change from Baseline is defined as the value at the safety follow up visit minus baseline value.
Time frame: Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24) and safety follow-up (Week 29)
Population: Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Baseline, n=7, 22 | 0.0 Ratio | Standard Deviation 0 |
| Matching Placebo | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Week 4, n=6, 17 | 0.3 Ratio | Standard Deviation 0.2 |
| Matching Placebo | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Week 8, n=6, 18 | 0.2 Ratio | Standard Deviation 0.6 |
| Matching Placebo | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Week 12, n=5, 16 | 0.2 Ratio | Standard Deviation 0.4 |
| Matching Placebo | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Week 16, n=5, 15 | 0.1 Ratio | Standard Deviation 0.5 |
| Matching Placebo | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Week 20, n=6, 13 | 0.0 Ratio | Standard Deviation 0.5 |
| Matching Placebo | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | End of Treatment, n=7, 19 | 0.1 Ratio | Standard Deviation 0.4 |
| Matching Placebo | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Safety follow-up, n=7, 20 | 0.1 Ratio | Standard Deviation 0.4 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Safety follow-up, n=7, 20 | 0.1 Ratio | Standard Deviation 0.6 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Baseline, n=7, 22 | 0.0 Ratio | Standard Deviation 0 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Week 16, n=5, 15 | 0.9 Ratio | Standard Deviation 0.7 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Week 4, n=6, 17 | 0.7 Ratio | Standard Deviation 0.4 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | End of Treatment, n=7, 19 | 0.5 Ratio | Standard Deviation 0.8 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Week 8, n=6, 18 | 0.9 Ratio | Standard Deviation 0.6 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Week 20, n=6, 13 | 0.7 Ratio | Standard Deviation 1.1 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Week 12, n=5, 16 | 0.9 Ratio | Standard Deviation 0.9 |
Secondary
Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29)
Fasted lipid laboratory parameters included triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol. Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.
Time frame: Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)
Population: Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, Week 4, n=8, 19 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 0.2 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, Week 20, n=6, 14 | 2.6 Millimoles per liter (mmol/L) | Standard Deviation 4.1 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, Week 8, n=7, 20 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 0.2 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, Week 8, n=7, 20 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 0.5 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, Week 12, n=6, 17 | -0.0 Millimoles per liter (mmol/L) | Standard Deviation 0.2 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, Week 8, n=7, 20 | 1.0 Millimoles per liter (mmol/L) | Standard Deviation 1.9 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, Week 16, n=5, 16 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 0.1 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, Week 12, n=6, 17 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 0.3 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, Week 20, n=6, 14 | -0.0 Millimoles per liter (mmol/L) | Standard Deviation 0.2 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, End of Treatment, n=7, 20 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.5 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, End of Treatment, n=7, 20 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 0.2 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, Week 16, n=5, 16 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 0.5 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, safety follow-up, n=9, 22 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 0.2 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, Week 16, n=5, 16 | 2.6 Millimoles per liter (mmol/L) | Standard Deviation 1.7 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, Week 4, n=8, 19 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 0.3 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, Week 20, n=6, 14 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 0.8 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, Week 8, n=7, 20 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 0.5 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, safety follow-up, n=9, 21 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 3.4 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, Week 12, n=6, 17 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 0.4 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, End of Treatment, n=8, 20 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 0.5 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, Week 16, n=5, 16 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 0.5 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, Week 12, n=6, 17 | 2.5 Millimoles per liter (mmol/L) | Standard Deviation 3.6 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, Week 20, n=6, 14 | -0.0 Millimoles per liter (mmol/L) | Standard Deviation 0.6 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, safety follow-up, n=9, 22 | -0.0 Millimoles per liter (mmol/L) | Standard Deviation 0.5 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, End of Treatment, n=7, 20 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 0.4 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, Week 4, n=9, 19 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 0.5 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, safety follow-up, n=9, 22 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 0.3 |
| Matching Placebo | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, Week 4, n=9, 19 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.3 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, safety follow-up, n=9, 22 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 0.5 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, Week 4, n=9, 19 | 2.4 Millimoles per liter (mmol/L) | Standard Deviation 3.7 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, Week 8, n=7, 20 | 3.8 Millimoles per liter (mmol/L) | Standard Deviation 5.7 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, Week 12, n=6, 17 | 5.8 Millimoles per liter (mmol/L) | Standard Deviation 8.7 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, Week 16, n=5, 16 | 4.2 Millimoles per liter (mmol/L) | Standard Deviation 5.2 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, Week 20, n=6, 14 | 5.6 Millimoles per liter (mmol/L) | Standard Deviation 6.2 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, End of Treatment, n=7, 20 | 3.3 Millimoles per liter (mmol/L) | Standard Deviation 5.6 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Triglycerides, safety follow-up, n=9, 21 | 2.8 Millimoles per liter (mmol/L) | Standard Deviation 5.8 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, Week 4, n=9, 19 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 0.6 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, Week 8, n=7, 20 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 0.8 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, Week 12, n=6, 17 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 0.9 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, Week 16, n=5, 16 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 0.8 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, Week 20, n=6, 14 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 1.1 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, End of Treatment, n=8, 20 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 0.7 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | Total cholesterol, safety follow-up, n=9, 22 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 0.8 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, Week 4, n=8, 19 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 0.1 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, Week 8, n=7, 20 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 0.2 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, Week 12, n=6, 17 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 0.2 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, Week 16, n=5, 16 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 0.2 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, Week 20, n=6, 14 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 0.2 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, End of Treatment, n=7, 20 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 0.2 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | HDL cholesterol, safety follow-up, n=9, 22 | -0.0 Millimoles per liter (mmol/L) | Standard Deviation 0.2 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, Week 4, n=8, 19 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 0.5 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, Week 8, n=7, 20 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 0.6 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, Week 12, n=6, 17 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 0.6 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, Week 16, n=5, 16 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 0.5 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, Week 20, n=6, 14 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 0.9 |
| Alitretinoin 30 mg | Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29) | LDL cholesterol, End of Treatment, n=7, 20 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 0.6 |
Secondary
Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24)
The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24). Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.
Time frame: Baseline, Week 12, and EOT (Week 24)
Population: Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24) | NAPSI-bed, Week 12, n=7, 17 | -0.4 Scores on a scale | Standard Deviation 1.1 |
| Matching Placebo | Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24) | NAPSI-bed, End of Treatment, n=8, 18 | 0.4 Scores on a scale | Standard Deviation 2.2 |
| Matching Placebo | Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24) | NAPSI-matrix, Week 12, n=7, 17 | -1.4 Scores on a scale | Standard Deviation 3.8 |
| Matching Placebo | Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24) | NAPSI-matrix, End of Treatment, n=8, 18 | 0.8 Scores on a scale | Standard Deviation 5.5 |
| Alitretinoin 30 mg | Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24) | NAPSI-matrix, End of Treatment, n=8, 18 | -0.1 Scores on a scale | Standard Deviation 5 |
| Alitretinoin 30 mg | Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24) | NAPSI-bed, Week 12, n=7, 17 | 0.3 Scores on a scale | Standard Deviation 2.4 |
| Alitretinoin 30 mg | Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24) | NAPSI-matrix, Week 12, n=7, 17 | -0.5 Scores on a scale | Standard Deviation 2 |
| Alitretinoin 30 mg | Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24) | NAPSI-bed, End of Treatment, n=8, 18 | -0.3 Scores on a scale | Standard Deviation 1.6 |
Secondary
Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)
The assessment of suicidality was conducted using the CSSRS, a brief questionnaire designed to assess severity and change in suicidality using a semi-structured interview to probe participant responses. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation. CSSRS scores were reported at Baseline; Week 4, 8, 12, 16, 20; EOT (Week 24); and safety follow-up (Week 29). Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.
Time frame: Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)
Population: Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 12, n=3, 7 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 20, n=2, 6 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 8, n=3, 9 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | End of Treatment, n=2, 7 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 16, n=2, 7 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Safety follow-up, n=3, 9 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 4, n=3, 9 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Safety follow-up, n=3, 9 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 4, n=3, 9 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 8, n=3, 9 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 12, n=3, 7 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 16, n=2, 7 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 20, n=2, 6 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | End of Treatment, n=2, 7 | 0.0 Scores on a scale | Standard Deviation 0 |
Secondary
Change From Baseline in Heart Rate at EOT (Week 24)
HR is defined as the rate at which the heart beats. Change from Baseline is defined as the value at EOT minus the Baseline value.
Time frame: Baseline and EOT (Week 24)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Matching Placebo | Change From Baseline in Heart Rate at EOT (Week 24) | -3.1 bpm | Standard Deviation 10.4 |
| Alitretinoin 30 mg | Change From Baseline in Heart Rate at EOT (Week 24) | -0.2 bpm | Standard Deviation 10.2 |
Secondary
Change From Baseline in SBP and DBP at EOT (Week 24)
Change from Baseline is defined as the value at EOT minus the Baseline value.
Time frame: Baseline and EOT (Week 24)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Change From Baseline in SBP and DBP at EOT (Week 24) | SBP | 0.5 mmHg | Standard Deviation 12.5 |
| Matching Placebo | Change From Baseline in SBP and DBP at EOT (Week 24) | DBP | -0.5 mmHg | Standard Deviation 9.8 |
| Alitretinoin 30 mg | Change From Baseline in SBP and DBP at EOT (Week 24) | SBP | 0.7 mmHg | Standard Deviation 19.1 |
| Alitretinoin 30 mg | Change From Baseline in SBP and DBP at EOT (Week 24) | DBP | -4.2 mmHg | Standard Deviation 9.8 |
Secondary
Change From Baseline in the mPASI Score at EOT (Week 24) or at the Last Assessment
Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on redness, thickness, and scaliness scores of plaques (0-4 each) for head, upper extremities, trunk, lower extremities and area of psoriatic involvement score (0-6). Lowest possible mPASI score was 0 and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values. Change from Baseline is defined as the value at EOT minus baseline value.
Time frame: Baseline and EOT (Week 24) or the last assessment
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Matching Placebo | Change From Baseline in the mPASI Score at EOT (Week 24) or at the Last Assessment | -95.8 Scores on a scale | Standard Deviation 7.2 |
| Alitretinoin 30 mg | Change From Baseline in the mPASI Score at EOT (Week 24) or at the Last Assessment | -51.0 Scores on a scale | Standard Deviation 38.3 |
p-value: 0.235895% CI: [-49.083, 148.07]ANCOVA
Secondary
Change From Baseline in Weight at EOT (Week 24)
Change from Baseline is defined as the value at EOT minus the value at Baseline.
Time frame: Baseline and EOT (Week 24)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Matching Placebo | Change From Baseline in Weight at EOT (Week 24) | -0.8 kg | Standard Deviation 3.2 |
| Alitretinoin 30 mg | Change From Baseline in Weight at EOT (Week 24) | -0.5 kg | Standard Deviation 1.4 |
Secondary
Mean Body Weight at Screening, Baseline ,and EOT (Week 24)
Body weight was measured at Screening, Baseline, and EOT.
Time frame: Screening, Baseline, and EOT (Week 24)
Population: Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Mean Body Weight at Screening, Baseline ,and EOT (Week 24) | Screening, n=9, 24 | 89.3 Kilograms (kg) | Standard Deviation 15.5 |
| Matching Placebo | Mean Body Weight at Screening, Baseline ,and EOT (Week 24) | Baseline, n=8, 24 | 89.6 Kilograms (kg) | Standard Deviation 16.6 |
| Matching Placebo | Mean Body Weight at Screening, Baseline ,and EOT (Week 24) | EOT, n=8, 19 | 88.9 Kilograms (kg) | Standard Deviation 16.5 |
| Alitretinoin 30 mg | Mean Body Weight at Screening, Baseline ,and EOT (Week 24) | Screening, n=9, 24 | 72.8 Kilograms (kg) | Standard Deviation 12.6 |
| Alitretinoin 30 mg | Mean Body Weight at Screening, Baseline ,and EOT (Week 24) | Baseline, n=8, 24 | 72.9 Kilograms (kg) | Standard Deviation 12.9 |
| Alitretinoin 30 mg | Mean Body Weight at Screening, Baseline ,and EOT (Week 24) | EOT, n=8, 19 | 73.8 Kilograms (kg) | Standard Deviation 13.4 |
Secondary
Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)
The CES-D scale is a short, self-report scale designed to measure depressive symptomatology in the general population. The CES-D consists of 20 questions. Participants were instructed to circle the number for each statement that best described how often they felt or behaved a particular way during the past week. The score was the sum of the weights of the 20 items. Responses range from 0 to 3 for each item (0=rarely or none of the time, 1=some or little of the time, 2=moderately or much of the time, 3=most or almost all the time). The CES-D score ranges from 0 to 60, with higher scores indicating greater depression. Participants with a CES-D score of 20 or higher were re-evaluated within 2 weeks. If a CES-D score of 20 or higher was confirmed on the second occasion, and if the score represents an increase over Baseline of 4 points or more, study treatment was interrupted and the participants were referred for psychiatric evaluation.
Time frame: Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)
Population: Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Baseline, n=9, 24 | 7.0 Scores on a scale | Standard Deviation 5.9 |
| Matching Placebo | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 16, n=6, 16 | 3.8 Scores on a scale | Standard Deviation 4.8 |
| Matching Placebo | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 8, n=7, 20 | 2.7 Scores on a scale | Standard Deviation 2.8 |
| Matching Placebo | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 20, n=6, 14 | 4.0 Scores on a scale | Standard Deviation 3.6 |
| Matching Placebo | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 4, n=9, 20 | 5.0 Scores on a scale | Standard Deviation 4.7 |
| Matching Placebo | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | End of Treatment, n=8, 20 | 7.4 Scores on a scale | Standard Deviation 9 |
| Matching Placebo | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 12, n=7, 17 | 4.0 Scores on a scale | Standard Deviation 5.7 |
| Matching Placebo | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Safety follow up, n=9, 22 | 4.4 Scores on a scale | Standard Deviation 3.9 |
| Matching Placebo | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Screening, n=9, 23 | 7.2 Scores on a scale | Standard Deviation 6.6 |
| Alitretinoin 30 mg | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Safety follow up, n=9, 22 | 4.6 Scores on a scale | Standard Deviation 6.7 |
| Alitretinoin 30 mg | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Screening, n=9, 23 | 5.7 Scores on a scale | Standard Deviation 4.7 |
| Alitretinoin 30 mg | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Baseline, n=9, 24 | 4.5 Scores on a scale | Standard Deviation 5.9 |
| Alitretinoin 30 mg | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 4, n=9, 20 | 2.9 Scores on a scale | Standard Deviation 3.5 |
| Alitretinoin 30 mg | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 8, n=7, 20 | 3.8 Scores on a scale | Standard Deviation 6.7 |
| Alitretinoin 30 mg | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 12, n=7, 17 | 4.2 Scores on a scale | Standard Deviation 6.6 |
| Alitretinoin 30 mg | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 16, n=6, 16 | 2.9 Scores on a scale | Standard Deviation 5.5 |
| Alitretinoin 30 mg | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 20, n=6, 14 | 3.6 Scores on a scale | Standard Deviation 5.2 |
| Alitretinoin 30 mg | Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | End of Treatment, n=8, 20 | 3.0 Scores on a scale | Standard Deviation 5.4 |
Secondary
Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)
The assessment of suicidality was conducted using the CSSRS, a brief questionnaire designed to assess severity and change in suicidality using a semi-structured interview to probe participant responses. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation. CSSRS scores were reported at Screening; Baseline; Week 4, 8, 12, 16, 20; EOT (Week 24);and safety follow-up (Week 29).
Time frame: Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24), and safety follow-up (Week 29)
Population: Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | End of Treatment, n=2, 7 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 4, n=3, 09 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Screening, n=3, 10 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 8, n=3, 09 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Safety follow up, n=3, 9 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 12, n=3, 07 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Baseline, n=3, 10 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 16, n=2, 07 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 20, n=2, 6 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 16, n=2, 07 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 20, n=2, 6 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | End of Treatment, n=2, 7 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Safety follow up, n=3, 9 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Screening, n=3, 10 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Baseline, n=3, 10 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 4, n=3, 09 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 8, n=3, 09 | 0.0 Scores on a scale | Standard Deviation 0 |
| Alitretinoin 30 mg | Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 12, n=3, 07 | 0.0 Scores on a scale | Standard Deviation 0 |
Secondary
Mean Heart Rate (HR) at Baseline, Screening, and EOT (Week 24)
HR is defined as the rate at which the heart beats.
Time frame: Screening, Baseline, and EOT (Week 24)
Population: Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Mean Heart Rate (HR) at Baseline, Screening, and EOT (Week 24) | Screening, n=9, 23 | 68.3 Beats per minute (bpm) | Standard Deviation 6 |
| Matching Placebo | Mean Heart Rate (HR) at Baseline, Screening, and EOT (Week 24) | Baseline, n=9, 24 | 72.3 Beats per minute (bpm) | Standard Deviation 6.2 |
| Matching Placebo | Mean Heart Rate (HR) at Baseline, Screening, and EOT (Week 24) | EOT, n=8, 20 | 70.1 Beats per minute (bpm) | Standard Deviation 6.6 |
| Alitretinoin 30 mg | Mean Heart Rate (HR) at Baseline, Screening, and EOT (Week 24) | Screening, n=9, 23 | 74.0 Beats per minute (bpm) | Standard Deviation 7.3 |
| Alitretinoin 30 mg | Mean Heart Rate (HR) at Baseline, Screening, and EOT (Week 24) | Baseline, n=9, 24 | 75.2 Beats per minute (bpm) | Standard Deviation 8.8 |
| Alitretinoin 30 mg | Mean Heart Rate (HR) at Baseline, Screening, and EOT (Week 24) | EOT, n=8, 20 | 74.7 Beats per minute (bpm) | Standard Deviation 7.8 |
Secondary
Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)
Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on the redness, thickness, and scaliness scores of plaques (0-4 each) for the head, upper extremities, trunk, and lower extremities and the area of psoriatic involvement score (0-6). The lowest possible mPASI score was zero and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values.
Time frame: Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)
Population: Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Week 8, n=7, 20 | 0.0 Scores on a scale | Standard Deviation 0.1 |
| Matching Placebo | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Week 16, n=6, 16 | 0.0 Scores on a scale | Standard Deviation 0 |
| Matching Placebo | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Week 4, n=9, 20 | 0.3 Scores on a scale | Standard Deviation 0.6 |
| Matching Placebo | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Week 20, n=6, 14 | 0.0 Scores on a scale | Standard Deviation 0.1 |
| Matching Placebo | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Week 12, n=7, 17 | 0.0 Scores on a scale | Standard Deviation 0.1 |
| Matching Placebo | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | End of Treatment, n=8, 20 | 0.7 Scores on a scale | Standard Deviation 1.9 |
| Matching Placebo | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Baseline, n=9, 21 | 0.2 Scores on a scale | Standard Deviation 0.4 |
| Alitretinoin 30 mg | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | End of Treatment, n=8, 20 | 0.3 Scores on a scale | Standard Deviation 0.7 |
| Alitretinoin 30 mg | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Baseline, n=9, 21 | 0.5 Scores on a scale | Standard Deviation 0.9 |
| Alitretinoin 30 mg | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Week 4, n=9, 20 | 0.4 Scores on a scale | Standard Deviation 0.9 |
| Alitretinoin 30 mg | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Week 8, n=7, 20 | 0.4 Scores on a scale | Standard Deviation 0.9 |
| Alitretinoin 30 mg | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Week 12, n=7, 17 | 0.4 Scores on a scale | Standard Deviation 0.9 |
| Alitretinoin 30 mg | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Week 16, n=6, 16 | 0.2 Scores on a scale | Standard Deviation 0.5 |
| Alitretinoin 30 mg | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Week 20, n=6, 14 | 0.1 Scores on a scale | Standard Deviation 0.3 |
p-value: 0.12Wilcoxon test: Exact Test
Secondary
Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24)
The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24).
Time frame: Baseline, Week 12, and EOT (Week 24)
Population: Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | NAPSI-bed, Baseline, n=9, 20 | 1.1 Scores on a scale | Standard Deviation 2.3 |
| Matching Placebo | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | NAPSI-bed, Week 12, n=7, 17 | 0.4 Scores on a scale | Standard Deviation 1.1 |
| Matching Placebo | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | NAPSI-bed, End of Treatment, n=8, 19 | 1.6 Scores on a scale | Standard Deviation 2.8 |
| Matching Placebo | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | NAPSI-matrix, Baseline, n=9, 20 | 3.9 Scores on a scale | Standard Deviation 6.2 |
| Matching Placebo | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | NAPSI-matrix, Week 12, n=7, 17 | 2.1 Scores on a scale | Standard Deviation 3.7 |
| Matching Placebo | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | NAPSI-matrix, End of Treatment, n=8, 19 | 4.3 Scores on a scale | Standard Deviation 6 |
| Alitretinoin 30 mg | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | NAPSI-matrix, Week 12, n=7, 17 | 2.6 Scores on a scale | Standard Deviation 6 |
| Alitretinoin 30 mg | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | NAPSI-bed, Baseline, n=9, 20 | 1.2 Scores on a scale | Standard Deviation 1.9 |
| Alitretinoin 30 mg | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | NAPSI-matrix, Baseline, n=9, 20 | 3.6 Scores on a scale | Standard Deviation 6.2 |
| Alitretinoin 30 mg | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | NAPSI-bed, Week 12, n=7, 17 | 1.3 Scores on a scale | Standard Deviation 3.3 |
| Alitretinoin 30 mg | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | NAPSI-matrix, End of Treatment, n=8, 19 | 2.6 Scores on a scale | Standard Deviation 6 |
| Alitretinoin 30 mg | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | NAPSI-bed, End of Treatment, n=8, 19 | 0.9 Scores on a scale | Standard Deviation 2 |
Secondary
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24)
SBP and DBP were assessed at Screening, Baseline, and EOT.
Time frame: Screening, Baseline, and EOT (Week 24)
Population: Safety Population. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24) | SBP, Screening, n=9, 23 | 130.8 Millimeters of mercury (mmHg) | Standard Deviation 13.7 |
| Matching Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24) | SBP, Baseline, n=9, 24 | 122.8 Millimeters of mercury (mmHg) | Standard Deviation 14 |
| Matching Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24) | SBP, EOT, n=8, 20 | 122.4 Millimeters of mercury (mmHg) | Standard Deviation 13.7 |
| Matching Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24) | DBP, Screening, n=9, 23 | 78.0 Millimeters of mercury (mmHg) | Standard Deviation 10.7 |
| Matching Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24) | DBP, Baseline, n=9, 24 | 77.4 Millimeters of mercury (mmHg) | Standard Deviation 12.2 |
| Matching Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24) | DBP, EOT, n=8, 20 | 76.0 Millimeters of mercury (mmHg) | Standard Deviation 12.2 |
| Alitretinoin 30 mg | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24) | DBP, Baseline, n=9, 24 | 79.1 Millimeters of mercury (mmHg) | Standard Deviation 7.5 |
| Alitretinoin 30 mg | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24) | SBP, Screening, n=9, 23 | 131.3 Millimeters of mercury (mmHg) | Standard Deviation 16.3 |
| Alitretinoin 30 mg | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24) | DBP, Screening, n=9, 23 | 79.7 Millimeters of mercury (mmHg) | Standard Deviation 9.6 |
| Alitretinoin 30 mg | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24) | SBP, Baseline, n=9, 24 | 126.3 Millimeters of mercury (mmHg) | Standard Deviation 16.1 |
| Alitretinoin 30 mg | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24) | DBP, EOT, n=8, 20 | 75.4 Millimeters of mercury (mmHg) | Standard Deviation 10.5 |
| Alitretinoin 30 mg | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24) | SBP, EOT, n=8, 20 | 128.7 Millimeters of mercury (mmHg) | Standard Deviation 21.4 |
Secondary
Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)
Serum pregnancy tests were performed at each visit for females of childbearing potential.
Time frame: Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); safety follow-up (Week 29)
Population: Safety population. Only female participants were analysed for serum pregnancy test.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Baseline | 4 Participants |
| Matching Placebo | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 16 | 3 Participants |
| Matching Placebo | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 8 | 3 Participants |
| Matching Placebo | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 20 | 2 Participants |
| Matching Placebo | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 4 | 4 Participants |
| Matching Placebo | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | EOT | 4 Participants |
| Matching Placebo | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 12 | 3 Participants |
| Matching Placebo | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Safety follow-up | 4 Participants |
| Matching Placebo | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Screening | 4 Participants |
| Alitretinoin 30 mg | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Safety follow-up | 5 Participants |
| Alitretinoin 30 mg | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Screening | 7 Participants |
| Alitretinoin 30 mg | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Baseline | 7 Participants |
| Alitretinoin 30 mg | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 4 | 4 Participants |
| Alitretinoin 30 mg | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 8 | 4 Participants |
| Alitretinoin 30 mg | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 12 | 3 Participants |
| Alitretinoin 30 mg | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 16 | 2 Participants |
| Alitretinoin 30 mg | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | Week 20 | 2 Participants |
| Alitretinoin 30 mg | Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29) | EOT | 4 Participants |
Secondary
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment
An AE was any adverse change from the participant's Baseline (pre-treatment) clinical condition, including intercurrent illness, which occurred during the course of a clinical study after written informed consent had been given, whether considered related to treatment or not. The relationship of AEs to the study treatment was assessed as unrelated, remotely related, possibly related, and probably related. For an AE to be considered serious, it fell into one or more of the following categories: results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, and is a congenital abnormality or birth defect.
Time frame: From Baseline until safety follow up (Week 29)
Population: Safety Population: all randomized participants who received at least one dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment | Any AE | 8 Participants |
| Matching Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment | Any AE remotely related to study medication | 6 Participants |
| Matching Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment | Any SAE | 0 Participants |
| Matching Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment | Any SAE remotely related to study medication | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment | Any SAE remotely related to study medication | 1 Participants |
| Alitretinoin 30 mg | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment | Any AE | 18 Participants |
| Alitretinoin 30 mg | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment | Any SAE | 1 Participants |
| Alitretinoin 30 mg | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment | Any AE remotely related to study medication | 15 Participants |
Secondary
Number of Participants With mPASI 50 Response and mPASI 75 Response
Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). The fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated. mPASI 50 response and mPASI 75 response is defined as a 50% and 75% decrease, respectively, in the mPASI score from Baseline.
Time frame: From Baseline until EOT (Week 24)
Population: Full analysis set. Participants with lesions in areas of the body other than the hands and feet were assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo | Number of Participants With mPASI 50 Response and mPASI 75 Response | mPASI 50 response | 3 Participants |
| Matching Placebo | Number of Participants With mPASI 50 Response and mPASI 75 Response | mPASI 75 response | 3 Participants |
| Alitretinoin 30 mg | Number of Participants With mPASI 50 Response and mPASI 75 Response | mPASI 50 response | 2 Participants |
| Alitretinoin 30 mg | Number of Participants With mPASI 50 Response and mPASI 75 Response | mPASI 75 response | 2 Participants |
p-value: 0.1667Fisher Exact
p-value: 0.1667Fisher Exact
Secondary
Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal
A physical examination for each participant was performed at Baseline and at EOT (Week 24). The primary investigator classified physical status as either normal or abnormal.
Time frame: Baseline and EOT (Week 24)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo | Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal | Baseline normal, worst post-Baseline normal | 6 Participants |
| Matching Placebo | Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal | Baseline normal, worst post-Baseline abnormal | 1 Participants |
| Matching Placebo | Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal | Baseline abnormal, worst post-Baseline normal | 1 Participants |
| Matching Placebo | Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal | Baseline abnormal, worst post-Baseline abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal | Baseline abnormal, worst post-Baseline abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal | Baseline normal, worst post-Baseline normal | 18 Participants |
| Alitretinoin 30 mg | Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal | Baseline abnormal, worst post-Baseline normal | 1 Participants |
| Alitretinoin 30 mg | Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal | Baseline normal, worst post-Baseline abnormal | 0 Participants |
Secondary
Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24)
Laboratory parameters included triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, LDL/HDL ratio, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and amylase and lipase. The central laboratory classified a finding as either abnormal or normal.
Time frame: From Baseline until EOT (Week 24)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | HDL cholesterol BL normal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | LDL/HDL ratio BL abnormal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Total cholesterol BL normal, shift to abnormal | 1 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | ALT BL normal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | HDL cholesterol BL abnormal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | ALT BL abnormal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Triglycerides, BL abnormal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | AST BL normal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | AST BL abnormal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | LDL cholesterol BL normal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Bilirubin BL normal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Total cholesterol BL abnormal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Bilirubin BL abnormal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | LDL cholesterol BL abnormal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Amylase BL normal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Triglycerides, BL normal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Lipase BL normal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | LDL/HDL ratio BL normal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Lipase BL abnormal, shift to abnormal | 0 Participants |
| Matching Placebo | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Amylase BL abnormal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Lipase BL abnormal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Amylase BL abnormal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | AST BL normal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Triglycerides, BL normal, shift to abnormal | 2 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Triglycerides, BL abnormal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Total cholesterol BL normal, shift to abnormal | 1 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Total cholesterol BL abnormal, shift to abnormal | 1 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | HDL cholesterol BL normal, shift to abnormal | 1 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | HDL cholesterol BL abnormal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | LDL cholesterol BL normal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | LDL cholesterol BL abnormal, shift to abnormal | 1 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | LDL/HDL ratio BL normal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | LDL/HDL ratio BL abnormal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | ALT BL normal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | ALT BL abnormal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | AST BL abnormal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Bilirubin BL normal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Bilirubin BL abnormal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Amylase BL normal, shift to abnormal | 0 Participants |
| Alitretinoin 30 mg | Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24) | Lipase BL normal, shift to abnormal | 0 Participants |
Secondary
Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24)
The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the EOT visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole.
Time frame: Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)
Population: Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Matching Placebo | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Week 8, n=7, 20 | 69.7 Pustule count | Standard Deviation 30.8 |
| Matching Placebo | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Week 16, n=6, 16 | 26.8 Pustule count | Standard Deviation 25.5 |
| Matching Placebo | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Week 4, n=9, 20 | 71.6 Pustule count | Standard Deviation 66.5 |
| Matching Placebo | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Week 20, n=6, 14 | 35.8 Pustule count | Standard Deviation 37.7 |
| Matching Placebo | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Week 12, n=7, 17 | 70.4 Pustule count | Standard Deviation 63.2 |
| Matching Placebo | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | End of Treatment, n=8, 20 | 55.4 Pustule count | Standard Deviation 104.5 |
| Matching Placebo | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Baseline, n=9, 22 | 82.7 Pustule count | Standard Deviation 59.1 |
| Alitretinoin 30 mg | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | End of Treatment, n=8, 20 | 33.6 Pustule count | Standard Deviation 49.6 |
| Alitretinoin 30 mg | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Baseline, n=9, 22 | 106.0 Pustule count | Standard Deviation 128.2 |
| Alitretinoin 30 mg | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Week 4, n=9, 20 | 31.0 Pustule count | Standard Deviation 43.5 |
| Alitretinoin 30 mg | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Week 8, n=7, 20 | 30.4 Pustule count | Standard Deviation 38.6 |
| Alitretinoin 30 mg | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Week 12, n=7, 17 | 21.5 Pustule count | Standard Deviation 37.8 |
| Alitretinoin 30 mg | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Week 16, n=6, 16 | 26.0 Pustule count | Standard Deviation 42 |
| Alitretinoin 30 mg | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Week 20, n=6, 14 | 30.5 Pustule count | Standard Deviation 51.2 |