Trial Outcomes & Findings for A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream (NCT NCT03308799)

Last Updated: 2024-12-09

Results Overview

Psoriasis treatment success rate is measured at week 8 by the use of a Physician Global Assessment (PGA) score. Success is defined as a decrease from Baseline of minimum 2 point on a scale from 0 - 4, where: 0 = Clear; 1 = Almost clear; 2 = Mild Plaque thickening; 3 = Moderate Plaque thickening, 4 = Severe Plaque thickening. The number of participants referred in the data sets are the number of participants, who achieved a successful treatment success.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

794 participants

Primary outcome timeframe

Baseline and 8 weeks

Results posted on

2024-12-09

Participant Flow

First Subject First Visit: 03-Oct-2017. Last Subject Last Visit: 08-Jun-2018.

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.

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 CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). 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
Overall Study STARTED	342	337	115
Overall Study COMPLETED	320	309	94
Overall Study NOT COMPLETED	22	28	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MC2-01 Cream n=342 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=337 Participants CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks. CAL/BDP combination: calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%	Vehicle n=115 Participants One application daily for 8 weeks. Vehicle	Total n=794 Participants Total of all reporting groups
Age, Continuous	52.0 Years STANDARD_DEVIATION 14.4 • n=5 Participants	52.6 Years STANDARD_DEVIATION 13.7 • n=7 Participants	50.4 Years STANDARD_DEVIATION 14.3 • n=5 Participants	52.0 Years STANDARD_DEVIATION 14.1 • n=4 Participants
Sex: Female, Male Female	139 Participants n=5 Participants	116 Participants n=7 Participants	44 Participants n=5 Participants	299 Participants n=4 Participants
Sex: Female, Male Male	203 Participants n=5 Participants	221 Participants n=7 Participants	71 Participants n=5 Participants	495 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	290 Participants n=5 Participants	299 Participants n=7 Participants	102 Participants n=5 Participants	691 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	34 Participants n=5 Participants	20 Participants n=7 Participants	11 Participants n=5 Participants	65 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	10 Participants n=5 Participants	10 Participants n=7 Participants	1 Participants n=5 Participants	21 Participants n=4 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Race · Mutiple	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	342 participants n=5 Participants	337 participants n=7 Participants	115 participants n=5 Participants	794 participants n=4 Participants
Baseline PGA Mild psoriasis	68 Participants n=5 Participants	57 Participants n=7 Participants	20 Participants n=5 Participants	145 Participants n=4 Participants
Baseline PGA Moderate psoriasis	274 Participants n=5 Participants	280 Participants n=7 Participants	95 Participants n=5 Participants	649 Participants n=4 Participants
Baseline mPASI	7.3 Calculated score STANDARD_DEVIATION 3.9 • n=5 Participants	7.7 Calculated score STANDARD_DEVIATION 4.1 • n=7 Participants	7.1 Calculated score STANDARD_DEVIATION 4.1 • n=5 Participants	7.4 Calculated score STANDARD_DEVIATION 4.0 • n=4 Participants
Baseline BSA	7.3 Percentage STANDARD_DEVIATION 6.0 • n=5 Participants	8.4 Percentage STANDARD_DEVIATION 7.0 • n=7 Participants	7.5 Percentage STANDARD_DEVIATION 6.1 • n=5 Participants	7.8 Percentage STANDARD_DEVIATION 6.5 • n=4 Participants
Fitzpatrick Skin Type I	21 Participants n=5 Participants	21 Participants n=7 Participants	9 Participants n=5 Participants	51 Participants n=4 Participants
Fitzpatrick Skin Type II	86 Participants n=5 Participants	88 Participants n=7 Participants	30 Participants n=5 Participants	204 Participants n=4 Participants
Fitzpatrick Skin Type III	104 Participants n=5 Participants	112 Participants n=7 Participants	37 Participants n=5 Participants	253 Participants n=4 Participants
Fitzpatrick Skin Type IV	87 Participants n=5 Participants	73 Participants n=7 Participants	23 Participants n=5 Participants	183 Participants n=4 Participants
Fitzpatrick Skin Type V	30 Participants n=5 Participants	28 Participants n=7 Participants	9 Participants n=5 Participants	67 Participants n=4 Participants
Fitzpatrick Skin Type VI	14 Participants n=5 Participants	15 Participants n=7 Participants	7 Participants n=5 Participants	36 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: The analysis was based on the PP population.

Outcome measures

Outcome measures
Measure	MC2-01 Cream n=302 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=279 Participants CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks. CAL/BDP combination: calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%	Vehicle n=88 Participants One application daily for 8 weeks. Vehicle
Number of Participants With a Decrease in the Physicians Global Assessment (PGA) Score of Minimum 2 Points on a Scale From 0-4 From Baseline to Week 8	121 Count of participants	67 Count of participants	4 Count of participants

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: The analysis was based on the PP population.

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 each 3 areas (arms, trunk and legs) 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

Outcome measures

Outcome measures
Measure	MC2-01 Cream n=302 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=279 Participants CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks. CAL/BDP combination: calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%	Vehicle n=88 Participants One application daily for 8 weeks. Vehicle
Percentage Change in mPASI Score	64.8 Percentage of change Standard Deviation 28.7	52.3 Percentage of change Standard Deviation 33.3	25.7 Percentage of change Standard Deviation 35.3

SECONDARY outcome

Timeframe: 8 weeks

Population: The analysis population is defined as those patients from the PP population that have used study medication within 7 days prior to the day of assessment.

Subject assessment of treatment convenience using a Psoriasis Treatment Convenience Scale is defined as a sum of questions 1-5, where each question is scored on a scale from 1-10. How easy was the treatment to apply to the skin? "Very difficult" is 1 and "Very easy" is 10 How greasy was the treatment when applying it to the skin? "Very greasy" is 1 and "Not greasy" is 10 How moisturised did your skin feel after applying the treatment? "Not moisturized" is 1 and "Very moisturized" is 10 How greasy did your skin feel after applying the treatment? "Very greasy" is 1 and "Not greasy" is 10 How much did treating your skin disrupt your daily routine? "Very disturbing" is 1 and "Not disturbing" is 10

Outcome measures

Outcome measures
Measure	MC2-01 Cream n=295 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=275 Participants CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks. CAL/BDP combination: calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%	Vehicle n=87 Participants One application daily for 8 weeks. Vehicle
Psoriasis Treatment Convenience Scale	41.6 score on a scale Standard Deviation 6.6	37.8 score on a scale Standard Deviation 7.6	37.2 score on a scale Standard Deviation 7.1

Adverse Events

MC2-01 Cream

Serious events: 9 serious events

Other events: 0 other events

Deaths: 1 deaths

CAL/BDP Combination

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle

Serious events: 5 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Birgitte Vestbjerg

MC2 Therapeutics

Phone: +45 2077 2575

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less or equal to 60 days from the time submitted to the sponsor for review. At the end of the Review Period, the sponsor may reasonably require that publication be delayed to permit the filing of patent application. Publication shall not be delayed more than 90 days after receipt of the proposed publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	MC2-01 Cream n=342 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=337 participants at risk CAL/BDP (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks. CAL/BDP combination: calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%	Vehicle n=115 participants at risk One application daily for 8 weeks. Vehicle
Skin and subcutaneous tissue disorders Abscess	0.29% 1/342 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.30% 1/337 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Cardiac disorders Angina Pectoris	0.29% 1/342 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.30% 1/337 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma	0.29% 1/342 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/337 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Musculoskeletal and connective tissue disorders Cervical Vertebral Fracture	0.29% 1/342 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/337 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Nervous system disorders Epilepsy	0.29% 1/342 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/337 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Infections and infestations Nosocomial infection	0.29% 1/342 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/337 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Renal and urinary disorders Acute Kidney injury	0.29% 1/342 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/337 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Infections and infestations Pneumonia	0.29% 1/342 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.30% 1/337 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Cardiac disorders Myocardial Infarction	0.29% 1/342 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/337 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.87% 1/115 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Metabolism and nutrition disorders Dehydration	0.00% 0/342 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.30% 1/337 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Infections and infestations Pyrexia	0.00% 0/342 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.30% 1/337 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Skin and subcutaneous tissue disorders Application site cellulitis	0.00% 0/342 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.30% 1/337 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.87% 1/115 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/342 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.30% 1/337 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Renal and urinary disorders Nephrolithiasis	0.00% 0/342 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.30% 1/337 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Cardiac disorders Atrial Fibrillation	0.00% 0/342 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.30% 1/337 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Gastrointestinal disorders Diverculitis	0.00% 0/342 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.30% 1/337 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma	0.00% 0/342 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.30% 1/337 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/115 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Gastrointestinal disorders Cholecystitis	0.00% 0/342 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/337 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.87% 1/115 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Cardiac disorders Ischaemic stroke	0.00% 0/342 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/337 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.87% 1/115 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.
Cardiac disorders Death	0.00% 0/342 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.00% 0/337 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.	0.87% 1/115 • Number of events 1 • AEs were collected/assessed during the screening period (up to 4 weeks) and during the 8 weeks treatment period.