Trial Outcomes & Findings for This Trial is a Randomised, Multicentre, Investigator-blind, Vehicle and Comparator-controlled, Parallel-group Trial With the Purpose of Evaluation Efficacy, Safety and Convenience of the MC2-01 Cream (NCT NCT03802344)

Last Updated: 2020-12-16

Results Overview

The extent and severity of the participant's psoriasis is assessed using a modified PASI scoring system (minus scalp, face, and flexures) at each 3 areas (arms, trunk and legs) using a scale from 0 - 6, where 0 = no psoriasis involvement and 6 = 90-100% involvement. The severity is assessed at the 3 areas for each of the sign redness, thickness and scaliness using a scale from 0 - 4, where 0 represents none and 4 represents very severe. The mPASI score is calculated from the individual scores by use of the following equation: Arms 0.2 (Redness + Thickness + Scaliness) E = X Trunk 0.3 (Redness + Thickness + Scaliness) E = Y Legs 0.4 (Redness + Thickness + Scaliness) E = Z The sum of X + Y + Z = m-PASI score resulting in a minimum score of 0 and a maximum score (worst possible) of 64.8. The percent change in mPASI score is defined as the Baseline minus the Week 8 divided by Baseline score multiplied by 100 (if a reduction is seen the value will be presented as a negative number)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

498 participants

Primary outcome timeframe

8 Weeks

Results posted on

2020-12-16

Participant Flow

First Subject First Visit: 12-Dec-2018. Last Subject Last Visit: 02-Oct-2019.

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 could last for up to 30 days, depending on which disallowed treatments the subject received. 498 subjects signed the Informed consent form, 490 subjects were randomized and randomly assigned into 3 treatment groups (MC2-01 cream, active comparator, MC2-01 vehicle).

Participant milestones

Participant milestones
Measure	MC2-01 Cream MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream	Cal/BDP Combination Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%	Vehicle One application daily for 8 weeks Vehicle: Vehicle
Overall Study STARTED	213	209	68
Overall Study COMPLETED	205	203	55
Overall Study NOT COMPLETED	8	6	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This Trial is a Randomised, Multicentre, Investigator-blind, Vehicle and Comparator-controlled, Parallel-group Trial With the Purpose of Evaluation Efficacy, Safety and Convenience of the MC2-01 Cream

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MC2-01 Cream n=213 Participants MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream	Cal/BDP Combination n=209 Participants Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%	Vehicle n=68 Participants One application daily for 8 weeks Vehicle: Vehicle	Total n=490 Participants Total of all reporting groups
Age, Continuous	48.6 years STANDARD_DEVIATION 13.7 • n=5 Participants	51.5 years STANDARD_DEVIATION 14.8 • n=7 Participants	50.8 years STANDARD_DEVIATION 13.1 • n=5 Participants	50.2 years STANDARD_DEVIATION 14.02 • n=4 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	96 Participants n=7 Participants	22 Participants n=5 Participants	195 Participants n=4 Participants
Sex: Female, Male Male	136 Participants n=5 Participants	113 Participants n=7 Participants	46 Participants n=5 Participants	295 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	213 Participants n=5 Participants	209 Participants n=7 Participants	68 Participants n=5 Participants	490 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	211 Participants n=5 Participants	205 Participants n=7 Participants	65 Participants n=5 Participants	481 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Race · Gipsy	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · North African	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment Czechia	64 participants n=5 Participants	63 participants n=7 Participants	20 participants n=5 Participants	147 participants n=4 Participants
Region of Enrollment Germany	94 participants n=5 Participants	90 participants n=7 Participants	30 participants n=5 Participants	214 participants n=4 Participants
Region of Enrollment Poland	55 participants n=5 Participants	56 participants n=7 Participants	18 participants n=5 Participants	129 participants n=4 Participants
Fitzpatrick Skin Type I	6 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Fitzpatrick Skin Type II	104 Participants n=5 Participants	103 Participants n=7 Participants	29 Participants n=5 Participants	236 Participants n=4 Participants
Fitzpatrick Skin Type III	77 Participants n=5 Participants	76 Participants n=7 Participants	25 Participants n=5 Participants	178 Participants n=4 Participants
Fitzpatrick Skin Type IV	20 Participants n=5 Participants	19 Participants n=7 Participants	9 Participants n=5 Participants	48 Participants n=4 Participants
Fitzpatrick Skin Type V	6 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	18 Participants n=4 Participants
Fitzpatrick Skin Type VI	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: 8 Weeks

Population: The analysis was based on the FAS population.

Outcome measures

Outcome measures
Measure	MC2-01 Cream n=213 Participants MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream	Cal/BDP Combination n=209 Participants Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%	Vehicle n=68 Participants One application daily for 8 weeks Vehicle: Vehicle
Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score	-67.5 Percentage change from Baseline Standard Error 20.8	-63.5 Percentage change from Baseline Standard Error 22.2	-11.7 Percentage change from Baseline Standard Error 21.9

SECONDARY outcome

Timeframe: 8 Weeks

Population: The analysis was based on the FAS population.

PTCS measures the impact and convenience of the treatment. The scale consists of 6 disease-specific questions, which individually will be rated on a 1-10 points scale, where a score of 1 represents the lowest satisfactory response with the treatment and 10 represents the highest satisfactory response. The questions are: Q1. How easy was the treatment to apply to the skin?; Q2. How greasy was the treatment when applying it to the skin?; Q3. How moisturized did your skin feel after apolying the treatment?; Q4. How greasy did your skin feel after applying the treatment?; Q5. How much did treating you skin disrupt your daily routine?; Q6. Overall, how satisfied were you with the medical treatment? The total PTCS score is calculated as the sum of the first 5 questions, ranging from 5 \[low satisfaction\] to 50 \[high satisfaction\].

Outcome measures

Outcome measures
Measure	MC2-01 Cream n=213 Participants MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream	Cal/BDP Combination n=209 Participants Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%	Vehicle n=68 Participants One application daily for 8 weeks Vehicle: Vehicle
The Psoriasis Treatment Convenience Scale (PTCS)	38.6 score on a scale Standard Deviation 6.2	36.1 score on a scale Standard Deviation 7.0	36.2 score on a scale Standard Deviation 7.6

Adverse Events

MC2-01 Cream

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Cal/BDP Combination

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Vehicle

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MC2-01 Cream n=213 participants at risk MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream	Cal/BDP Combination n=209 participants at risk Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%	Vehicle n=68 participants at risk One application daily for 8 weeks Vehicle: Vehicle
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular seminoma	0.47% 1/213 • Number of events 1 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.	0.00% 0/209 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.	0.00% 0/68 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.
Infections and infestations Herpes zoster meningitis	0.00% 0/213 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.	0.48% 1/209 • Number of events 1 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.	0.00% 0/68 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.
Musculoskeletal and connective tissue disorders Humerus fracture	0.00% 0/213 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.	0.48% 1/209 • Number of events 1 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.	0.00% 0/68 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.
Infections and infestations Pulmonary tuberculosis	0.00% 0/213 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.	0.48% 1/209 • Number of events 1 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.	0.00% 0/68 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.
Gastrointestinal disorders Cholesystitis acute	0.00% 0/213 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.	0.00% 0/209 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.	1.5% 1/68 • Number of events 1 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.

Other adverse events

Other adverse events
Measure	MC2-01 Cream n=213 participants at risk MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream	Cal/BDP Combination n=209 participants at risk Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks Cal/BDP combination: Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%	Vehicle n=68 participants at risk One application daily for 8 weeks Vehicle: Vehicle
Infections and infestations Nasopharyngitis	4.7% 10/213 • Number of events 10 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.	5.3% 11/209 • Number of events 11 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.	1.5% 1/68 • Number of events 1 • AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the end of the trial, i.e. until the Follow-up visit at Week 10. 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.

Additional Information

Irene Sandholdt

MC2 Therapeutics

Phone: +45 2015 7033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place