Psoriasis VulgarisPhase 2NCT03462927

A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream

A Phase 2 study testing MC2-01 Cream and CAL/BDP combination in people with Psoriasis Vulgaris, run by MC2 Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis Vulgaris
What is being tested?: MC2-01 Cream and CAL/BDP combination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteUnited States
Study dates: 8 Feb 2018to 4 Aug 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have provided written informed consent.
Generally healthy males or non-pregnant females, of any race or ethnicity, who are at least 18 years of age at the time of screening.
At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration involving scalp and body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 100 g of trial medication per week.
Have a Physician's Global Assessment [PGA] of severity of at least moderate on the trunk, limbs and/or scalp, at Visit 1/Day 0.
Have a treatment area between 20% and 30% of the body surface area [BSA] on the trunk, limbs and/or scalp, excluding psoriatic lesions on the face, genitals, and intertriginous areas, at Visit 1/Day 0.

Who cannot join

Current diagnosis of unstable forms of psoriasis
Other inflammatory skin disease in the treatment area
Pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas
Planned exposure to natural or artificial sunlight
Phototherapy and ultraviolet B radiation within 4 weeks prior to Visit 1/Baseline and during the trial;
Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders;

Show all 19Show fewer

Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin within 4 weeks prior to Visit 1/Day 0 during the trial period.
Planned initiation of, or changes to concomitant medication that could affect calcium metabolism during the trial;
Planned initiation of, or changes to, concomitant estrogen therapy during the trial;
Strong systemic cytochrome P450 3A4 (CYP 3A4) inhibitors within 4 weeks prior to Vist 1/Day 0 and during the trial period;
Use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to Visit 1/Day 0 and during the trial period;
Systemic treatment with biological therapies
Initiation of, or expected changes to, concomitant medication that may affect psoriasis during the trial period;
Depression and endocrine disorders known to affect cortisol levels or HPA axis integrity, non-nocturnal sleep patterns
Systemic medication that suppresses the immune system within 4 weeks prior to the Visit 1/Day 0 and during the trial period;
Clinical signs of skin infection with bacteria, viruses, or fungi;
Known human immunodeficiency virus [HIV] infection;
Known or suspected of hypersensitivity to any component of the test product or reference product;
Any chronic or acute medical condition that may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial;

Trial locations and contacts

1 site in 1 country.

United States1 site

Lenus Research and Medical Group
Sweetwater, Florida, 33172

Other trials in United States

About this study

Official title: A Randomised, Open-label, Maximal Use Trial, Evaluating the Pharmacokinetic Profile of Active Ingredients and Their Metabolites After Application of MC2-01 Cream Compared With Active Comparator in Subjects With Extensive Psoriasis Vulgaris

Read the detailed description

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.

Conditions: Psoriasis Vulgaris
Being tested: MC2-01 Cream, CAL/BDP combination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MC2-01 CreamDrug
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)
CAL/BDP combinationDrug
Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)

Study groups in NCT03462927
Study group	Role	What they receive
MC2-01 Cream	Experimental	MC2-01 cream (CAL and BDP, w/w 0.005%/ 0.064%). Receives: Drug: MC2-01 Cream
CAL/BDP combination	Active comparator	CAL/BDP ointment (w/w 0.005%/0.064%). Receives: Drug: CAL/BDP combination

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 4
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
Measured: 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
Measured: 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
Measured: Week 8

Secondary outcomes (8)

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
Measured: 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
Measured: Week 8
Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium
Changes from baseline of albumin-corrected serum calcium [mmol/L]
Measured: Baseline and week 4
Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium
Changes from baseline in albumin-corrected serum calcium [mmol/L]
Measured: Baseline and week 8
Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion
Changes from baseline of 24-hour urinary calcium excretion [mmol/day]
Measured: Baseline and week 4
Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion
Changes from baseline of 24-hour urinary calcium excretion [mmol/day]
Measured: 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)
Measured: 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)
Measured: Baseline and week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 20184 Aug 2018

First posted13 Mar 2018
Study start8 Feb 2018
Primary completion4 Aug 2018
Study completion4 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03462927
Sponsor's protocol ID: MC2-01-C3
Status last verified: Dec 2019
First submitted: 20 Feb 2018
Last updated: 24 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
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Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
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All Psoriasis Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Open-label, Maximal Use Trial, Evaluating the Pharmacokinetic Profile of Active Ingredients and Their Metabolites After Application of MC2-01 Cream Compared With Active Comparator in Subjects With Extensive Psoriasis Vulgaris
ClinicalTrials.gov ID: NCT03462927
Acronym / sponsor ID: MC2-01-C3
Conditions: Psoriasis Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: MC2 TherapeuticsIndustry (pharma, biotech, devices)
Study start: 8 Feb 2018 (actual)
Primary completion: 4 Aug 2018 (actual)
Study completion: 4 Aug 2018 (actual)
First posted: 13 Mar 2018 (actual)
Results: Posted 24 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MC2-01 Cream	Experimental	Drug: MC2-01 CreamMC2-01 cream (CAL and BDP, w/w 0.005%/ 0.064%).
CAL/BDP combination	Active comparator	Drug: CAL/BDP combinationCAL/BDP ointment (w/w 0.005%/0.064%).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Have provided written informed consent.
Generally healthy males or non-pregnant females, of any race or ethnicity, who are at least 18 years of age at the time of screening.
At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration involving scalp and body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 100 g of trial medication per week.
Have a Physician's Global Assessment [PGA] of severity of at least moderate on the trunk, limbs and/or scalp, at Visit 1/Day 0.
Have a treatment area between 20% and 30% of the body surface area [BSA] on the trunk, limbs and/or scalp, excluding psoriatic lesions on the face, genitals, and intertriginous areas, at Visit 1/Day 0.

Key exclusion criteria (19 listed)

Current diagnosis of unstable forms of psoriasis
Other inflammatory skin disease in the treatment area
Pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas
Planned exposure to natural or artificial sunlight
Phototherapy and ultraviolet B radiation within 4 weeks prior to Visit 1/Baseline and during the trial;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MC2-01 CreamMC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)	Drug	MC2-01 Cream
CAL/BDP combinationCalcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)	Drug	CAL/BDP combination

Primary outcome

Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene
Time frame: Week 4
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
Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene
Time frame: Week 8
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
Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate
Time frame: Week 4
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
Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate
Time frame: Week 8
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
Maximum Plasma Concentration (Cmax) of the Metabolite MC1080
Time frame: Week 4
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
Maximum Plasma Concentration (Cmax) of the Metabolite MC1080
Time frame: Week 8
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
Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate
Time frame: Week 4
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
Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate
Time frame: Week 8
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

8 secondary outcomes

Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 4 Weeks of Treatment
Time frame: Week 4
Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 8 Weeks of Treatment
Time frame: Week 8
Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium
Time frame: Baseline and week 4
Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium
Time frame: Baseline and week 8
Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion
Time frame: Baseline and week 4
Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion
Time frame: Baseline and week 8
Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine
Time frame: Baseline and week 4
Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine
Time frame: Baseline and week 8

Results and safety

Results posted to the registry on 24 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MC2-01 Cream	32	26
CAL/BDP Combination	31	29

Primary outcome: Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene

Time frame: Week 4. Geometric mean (95% Confidence Interval). Unit: pg/mL

Measure	MC2-01 Cream n = 27	CAL/BDP Ointment n = 27
Value	30.2 (29.8 to 30.7)	30.0 (30 to 30)

Population analysed: 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

Primary outcome: Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene

Time frame: Week 8. Geometric mean (95% Confidence Interval). Unit: pg/mL

Measure	MC2-01 Cream n = 19
Value	30.0 (30.0 to 30.0)

Population analysed: 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

Primary outcome: Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate

Time frame: Week 4. Geometric mean (95% Confidence Interval). Unit: pg/mL

Measure	MC2-01 Cream n = 27	CAL/BDP Combination n = 27
Value	21.5 (19.5 to 23.7)	23.1 (19.0 to 28.1)

Population analysed: 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

Primary outcome: Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate

Time frame: Week 8. Geometric mean (95% Confidence Interval). Unit: pg/mL

Measure	MC2-01 Cream n = 19
Value	20.0 (20.0 to 20.0)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MC2-01 Cream	0 of 32 (0%)	0 of 32 (0%)	0 of 32
CAL/BDP Combination	1 of 31 (3.2%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Psoriasis Vulgaris

Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
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RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
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RecruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

George Han principal investigator

Department of Dermatology, Mount Sinai Beth Israel

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MC2-01 Cream and CAL/BDP combination in people with Psoriasis Vulgaris, run by MC2 Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene (time frame: Week 4). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03462927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.