Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase 2, randomised, open-label, parallel-group, multicentre trial in which MC2-01 cream and calcipotriene [CAL]/betamethasone [BDP] ointment (comparator) is investigated in subjects with clinically diagnosed extensive psoriasis vulgaris.
The MC2-01 cream is designed for optimal patient satisfaction - it quickly absorbs into the skin leaving it nicely moisturized allowing patients to move on with daily routines. In this trial, the MC2-01 cream will be compared to a marketed calcipotriene [CAL]/betamethasone dipropionate [BDP] ointment. The purpose of the trial, is to determine the pharmacokinetic parameters of MC2-01 cream and the comparator under maximum use conditions.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MC2-01 Cream | Experimental | MC2-01 cream (CAL and BDP, w/w 0.005%/ 0.064%). |
|
| CAL/BDP combination | Active Comparator | CAL/BDP ointment (w/w 0.005%/0.064%). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MC2-01 Cream | Drug | MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene | Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | Week 4 |
| Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene | Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | Week 8 |
| Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate | Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | Week 4 |
| Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate | Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | Week 8 |
| Maximum Plasma Concentration (Cmax) of the Metabolite MC1080 | Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | Week 4 |
| Maximum Plasma Concentration (Cmax) of the Metabolite MC1080 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 4 Weeks of Treatment | The HPA axis evaluation is based on an Adrenocorticotropic hormone [ACTH] challenge test, defined by a 30 minutes ACTH stimulated cortisol value. Only subject with no HPA suppression at baseline were included in the analysis. The outcome measure lists the number of subjects with HPA suppression 30 minutes after ACTH challenge |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| George Han | Department of Dermatology, Mount Sinai Beth Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lenus Research and Medical Group | Sweetwater | Florida | 33172 | United States |
Prior to randomization, the subject entered a washout period (if required) where anti-psoriatic treatment and other relevant medication/treatments were discontinued as defined by the exclusion criteria. The washout/screening period lasted for up to 4 weeks depending on which disallowed treatments the subject received.
First Subject First Visit: 08Feb-2018. Last Subject Last Visit: 04-Aug-2018.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MC2-01 Cream | MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%). One application daily for 8 weeks. MC2-01 Cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) |
| FG001 | CAL/BDP Combination | CAL/BDP ointment (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%, w/w 0.005%/0.064%). One daily application for 4 weeks. CAL/BDP combination: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MC2-01 Cream | MC2-01 cream (CAL and BDP, w/w 0.005%/ 0.064%). MC2-01 Cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) |
| BG001 | CAL/BDP Combination | CAL/BDP ointment (w/w 0.005%/0.064%). CAL/BDP combination: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene | Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | 9 subjects were excluded from the PK evaluation at Week 4: 5 in the MC2-01 cream group and 4 in the active comparator group | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Week 4 |
|
AEs were collected/assessed from the time of the signature of the informed consent form by the subject during the screening visit (up to 4 weeks prior to treatment), during the treatment period (up to 8 weeks) and until the final follow-up visit had occurred (up to 4 weeks following end of treatment). All AEs that were considered related to the trial product would be followed until they were resolved, or until the medical condition of the subject was stable
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MC2-01 Cream | MC2-01 cream (CAL and BDP, w/w 0.005%/ 0.064%). MC2-01 Cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Birgitte Vestbjerg | MC2 Therapeutics | +45 2077 2575 | bve@mc2therapeutics.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 20, 2017 | Jul 24, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2018 | Aug 21, 2019 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CAL/BDP combination |
| Drug |
Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%) |
|
Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose |
| Week 8 |
| Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate | Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | Week 4 |
| Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate | Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | Week 8 |
| Week 4 |
| Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 8 Weeks of Treatment | The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. Out of a total of 32 subjects, 5 subjects were excluded from the analysis as they had HPA suppression at baseline | Week 8 |
| Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium | Changes from baseline of albumin-corrected serum calcium [mmol/L] | Baseline and week 4 |
| Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium | Changes from baseline in albumin-corrected serum calcium [mmol/L] | Baseline and week 8 |
| Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion | Changes from baseline of 24-hour urinary calcium excretion [mmol/day] | Baseline and week 4 |
| Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion | Changes from baseline of 24-hour urinary calcium excretion [mmol/day] | Baseline and week 8 |
| Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine | Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g) | Baseline and week 4 |
| Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine | Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g) | Baseline and week 8 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Physician's Global Assessment (PGA) | Severity of psoriasis at Baseline | Count of Participants | Participants |
|
| Baseline Body Surface Area (BSA) | Percentage involvement of psoriasis on the BSA at Baseline | Mean | Standard Deviation | Percentage of psoriasis involvement |
|
| Fitzpatrick Skin Type | Measure Description: Fitzpatrick Skin Type was recorded at baseline using the following classification: I = Pale white skin, blue/hazel eyes, blond/red hair; II = Fair skin, blue eyes; III = Darker white skin; IV = Light brown skin; V = Brown skin; VI = Dark brown or black skin | Count of Participants | Participants |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene | Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | As per protocol, only subjects assigned to the MC2-01 cream had samples for PK testing collected at week 8. Only subjects that had a computable value of the PK parameter have been included in the analysis | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Week 8 |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate | Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | 9 subjects were excluded from the PK evaluation at Week 4: 5 in the MC2-01 cream group and 4 in the active comparator group | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Week 4 |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate | Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | As per protocol, only subjects assigned to the MC2-01 cream had samples for PK testing collected at week 8. Only subjects that had a computable value of the PK parameter have been included in the analysis | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Week 8 |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of the Metabolite MC1080 | Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | 9 subjects were excluded from the PK evaluation at Week 4: 5 in the MC2-01 cream group and 4 in active comparator group | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Week 4 |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of the Metabolite MC1080 | Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | As per protocol, only subjects assigned to the MC2-01 cream had samples for PK testing collected at week 8. Only subjects that had a computable value of the PK parameter have been included in the analysis | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Week 8 |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate | Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | 9 subjects were excluded from the PK evaluation at Week 4: 5 in the MC2-01 cream group and 4 in active comparator group | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Week 4 |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate | Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose | As per protocol, only subjects assigned to the MC2-01 cream had samples for PK testing collected at week 8. Only subjects that had a computable value of the PK parameter have been included in the analysis | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Week 8 |
|
|
|
| Secondary | Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 4 Weeks of Treatment | The HPA axis evaluation is based on an Adrenocorticotropic hormone [ACTH] challenge test, defined by a 30 minutes ACTH stimulated cortisol value. Only subject with no HPA suppression at baseline were included in the analysis. The outcome measure lists the number of subjects with HPA suppression 30 minutes after ACTH challenge | The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. No data were collected from the CAL/BDP Ointment group. Out of a total of 32 subjects, 5 subjects were excluded from the analysis as they had HPA suppression at baseline | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Secondary | Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 8 Weeks of Treatment | The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. Out of a total of 32 subjects, 5 subjects were excluded from the analysis as they had HPA suppression at baseline | The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. No data were collected from the CAL/BDP Ointment group. Out of a total of 32 subjects, 6 subjects were excluded from the analysis; 5 as they had HPA suppression at baseline and 1 who withdrew consent | Posted | Count of Participants | Participants | Week 8 |
|
|
|
| Secondary | Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium | Changes from baseline of albumin-corrected serum calcium [mmol/L] | As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 5 subjects in the MC2-01 cream group were excluded from the analysis | Posted | Mean | Standard Deviation | mmol/L | Baseline and week 4 |
|
|
|
| Secondary | Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium | Changes from baseline in albumin-corrected serum calcium [mmol/L] | As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 6 subjects in the MC2-01 cream group were excluded from the analysis | Posted | Mean | Standard Deviation | mmol/L | Baseline and week 8 |
|
|
|
| Secondary | Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion | Changes from baseline of 24-hour urinary calcium excretion [mmol/day] | As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 8 subjects in the MC2-01 cream group were excluded from the analysis | Posted | Mean | Standard Deviation | mmol/day | Baseline and week 4 |
|
|
|
| Secondary | Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion | Changes from baseline of 24-hour urinary calcium excretion [mmol/day] | As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 12 subjects in the MC2-01 cream group were excluded from the analysis | Posted | Mean | Standard Deviation | mmol/day | Baseline and week 8 |
|
|
|
| Secondary | Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine | Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g) | As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 8 subjects in the MC2-01 cream group were excluded from the analysis | Posted | Mean | Standard Deviation | mmol/g | Baseline and week 4 |
|
|
|
| Secondary | Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine | Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g) | As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 12 subjects in the MC2-01 cream group were excluded from the analysis | Posted | Mean | Standard Deviation | mmol/g | Baseline and week 8 |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | CAL/BDP Combination | CAL/BDP ointment (w/w 0.005%/0.064%). CAL/BDP combination: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%) | 0 | 31 | 1 | 31 | 0 | 31 |
Not provided