NCT03819218

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

Terminated Phase 2 Results posted Last updated 19 March 2021

What this trial tests

Phase 2 trial testing MC2-01 cream in Psoriasis Vulgaris in 7 participants. Terminated before completion.

Timeline

27 December 2018

Primary endpoint
11 December 2020

11 December 2020

Quick facts

Lead sponsor	MC2 Therapeutics
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	27 December 2018
Primary completion	11 December 2020
Estimated completion	11 December 2020
Sites	2 locations across Germany, Czechia

Drugs / interventions tested

• MC2-01 cream — full drug profile →

Conditions studied

• Psoriasis Vulgaris — all drugs for Psoriasis Vulgaris →

Sponsor

MC2 Therapeutics — full company profile →

Who can join

Adults 12 to 16, any sex, with Psoriasis Vulgaris. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 4 Primary · Week 4

Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression. The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL

Group	Value	95% CI
MC2-01 Cream	0

Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 8 Primary · Week 8

Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression. The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL

Group	Value	95% CI
MC2-01 Cream	0

Change in S-Calcium Metabolism at Week 4 Primary · Week 4

Change from Baseline to Week 4 in albumin-corrected S-calcium

Group	Value	95% CI
MC2-01 Cream	-0.037	± 0.084

Change in S-Calcium Metabolism at Week 8 Primary · Week 8

Change from Baseline to Week 8 in albumin-corrected S-calcium

Group	Value	95% CI
MC2-01 Cream	-0.027	± 0.060

Change in U-Calcium Metabolism at Week 4 Primary · Week 4

Change from Baseline to Week 4 in Urinary Calcium/Creatinine ratio (mol/mol)

Group	Value	95% CI
MC2-01 Cream	0.115	± 0.426

Change in U-Calcium Metabolism at Week 8 Primary · Week 8

Change from Baseline to Week 8 in Urinary Calcium/Creatinine ratio (mol/mol)

Group	Value	95% CI
MC2-01 Cream	0.058	± 0,186

The Maximum Plasma Concentration [Cmax] of Betamethasone 17-propionate at Week 4 Secondary · Week 4

The Maximum Plasma Concentration \[Cmax\] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.

Group	Value	95% CI
MC2-01 Cream	37.53	± 22.82

Time to Maximum Plasma Drug Concentration [Tmax] of Betamethasone 17-propionate at Week 4 Secondary · Week 4

Time to maximum plasma drug concentration \[Tmax\] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.

Group	Value	95% CI
MC2-01 Cream	2.333	± 1.155

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs were collected/assessed from the time of the signature of the informed consent form by the participant and until the final follow-up visit has occurred, i.e. up to in total up to 18 weeks, including a screening period of up to 6 weeks, a treatment period of 8 weeks and a follow-up period of 4 weeks. AEs that were considered related to the trial product would be followed until they were resolved, or until the medical condition of the participant was stable.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MC2-01 Cream

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (4 terms — click to expand)

Reaction	System	MC2-01 Cream
Nasopharyngitis	Infections and infestations	—
Tonsillitis	Infections and infestations	—
Dysuria	Renal and urinary disorders	—
Acne	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03819218 adverse events section.

Sponsor's own description

This is a phase 2, open-label, single-group, multicentre trial in which the investigational product, MC2-01 cream, is investigated in adolescent subjects (age 12 to 16 years, 11 months) with clinically diagnosed extensive psoriasis vulgaris.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.