Clinical Trial Results:
A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to Vehicle and Active Comparator in Subjects with Mild-to-Moderate Psoriasis Vulgaris
Summary
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EudraCT number |
2018-001970-66 |
Trial protocol |
CZ |
Global end of trial date |
02 Oct 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Nov 2020
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First version publication date |
30 Nov 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MC2-01-C7
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03802344 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
IND number: 127152 | ||
Sponsors
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Sponsor organisation name |
MC2 Therapeutics Ltd
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Sponsor organisation address |
C/O Agern Allé 24-26, Hørsholm, Denmark, 2970
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Public contact |
Senior Project Manager, Clinical Operations, MC2 Therapeutics Ltd, +45 20157033, isa@mc2Therapeutics.com
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Scientific contact |
Senior Project Manager, Clinical Operations, MC2 Therapeutics Ltd, +45 20157033, isa@mc2Therapeutics.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Oct 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Oct 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Oct 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective is to evaluate the efficacy of MC2-01 cream compared to active comparator in subjects with psoriasis vulgaris.
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Protection of trial subjects |
The MC2-01 cream contains two well-known active compounds (CAL/BDP) in a novel topical formulation.
The efficacy and safety profile of the combination is well established and have proven to be safe and
efficacious, and available data for MC2-01 cream suggest a very benign safety profile resembling that
known from the approved CAL/BDP products. A cream formulation of CAL and BDP may benefit subjects by providing improved convenience and ease of use resulting in increased patient adherence to therapy which will improve real-life treatment outcome.
Diavobet gel is used as comparator for this trial. The common AE (>1%) is pruritus. Other uncommon AEs are folliculitis, skin infections, exacerbation of psoriasis, dermatitis, erythema, rash, skin irritation, skin burning sensation, application site pain, as well as eye irritation (i.e. ≥0.1% and < 1%).
It was thus considered that the benefit of obtaining clinical data for this trial outweighed any potential risks.
AEs were collected/assessed from the time of the signature of the informed consent form by the subject and
until the final follow-up visit. 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.
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Background therapy |
- | ||
Evidence for comparator |
Daivobet gel was used as comparator product. It is a approved product with a well known safety profile. | ||
Actual start date of recruitment |
12 Dec 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 129
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Country: Number of subjects enrolled |
Czech Republic: 147
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Country: Number of subjects enrolled |
Germany: 214
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Worldwide total number of subjects |
490
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EEA total number of subjects |
490
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
407
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From 65 to 84 years |
83
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85 years and over |
0
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Recruitment
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Recruitment details |
All subjects approached for the study were either ongoing or new patients referred to the clinics with the diagnosis Psoriasis Vulgaris. | ||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
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. | ||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Treatment period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Assessor | ||||||||||||||||||||||||||||||||
Blinding implementation details |
Due to difference in formulation and packaging, the investigator and staff could not see the IP. Several precautions was taken to maintain the blind. To keep the staff blinded, packing and labelling of the outer box was be identical for all IPs, but the content varied. Handling of individual IPs was therefore be handled by a designated third unblinded person. This person was only involved in the handling of IP and did not perform any trial related assessment.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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MC2-01 Cream | ||||||||||||||||||||||||||||||||
Arm description |
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks. | ||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
MC2-01 Cream
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Topical use
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Dosage and administration details |
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream
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Arm title
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Active Comparator | ||||||||||||||||||||||||||||||||
Arm description |
Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks. | ||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Devobet/Devobet gel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Gel
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Routes of administration |
Topical use
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Dosage and administration details |
Devobet / Devobet gel: (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%)
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Arm title
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Vehicle | ||||||||||||||||||||||||||||||||
Arm description |
Vehicle One application daily for 8 weeks. | ||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Vehicle
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Topical use
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Dosage and administration details |
One application daily for 8 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
MC2-01 Cream
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Reporting group description |
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Active Comparator
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Reporting group description |
Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Vehicle
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Reporting group description |
Vehicle One application daily for 8 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
MC2-01 Cream
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Reporting group description |
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks. | ||
Reporting group title |
Active Comparator
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Reporting group description |
Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks. | ||
Reporting group title |
Vehicle
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Reporting group description |
Vehicle One application daily for 8 weeks. |
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End point title |
mPASI | ||||||||||||||||
End point description |
Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score.
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.
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End point type |
Primary
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End point timeframe |
The percent change in mPASI score is defined as the Baseline minus the Week 8 divided by Baseline score multiplied by 100 (this value is negative)
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Statistical analysis title |
mPASI | ||||||||||||||||
Comparison groups |
Active Comparator v MC2-01 Cream v Vehicle
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Number of subjects included in analysis |
490
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
ANCOVA | ||||||||||||||||
Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
- | ||||||||||||||||
upper limit |
- |
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Adverse events information
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Timeframe for reporting adverse events |
AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the final follow-up visit.
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Adverse event reporting additional description |
AEs that were considered related to the trial product would be followed until they were resolved, or until the medical condition was stable.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
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Reporting groups
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Reporting group title |
MC2-01 Cream
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Reporting group description |
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Reporting group title |
Cal/BDP Combination
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Reporting group description |
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Reporting group title |
Vehicle
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Reporting group description |
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |