Trial Outcomes & Findings for A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream in Adolescent Subjects (NCT NCT03819218)

NCT ID: NCT03819218

Last Updated: 2021-03-19

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: Week 4
• Results posted on: 2021-03-19

Participant Flow

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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
Overall Study Protocol Violation	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	MC2-01 Cream n=7 Participants MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
Age, Continuous	14.7 years STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Czechia	5 participants n=5 Participants
Region of Enrollment Germany	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: The HPA population was defined as all subjects in the safety population that showed a normal HPA function at the screening visit.

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

Outcome measures

Measure	MC2-01 Cream n=6 Participants MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 4	0 Participants

PRIMARY outcome

Timeframe: Week 8

Population: The HPA population was defined as all subjects in the safety population that showed a normal HPA function at the screening visit.

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

Outcome measures

Measure	MC2-01 Cream n=6 Participants MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 8	0 Participants

PRIMARY outcome

Timeframe: Week 4

Population: 7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.

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

Outcome measures

Measure	MC2-01 Cream n=7 Participants MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
Change in S-Calcium Metabolism at Week 4	-0.037 mmol/L Standard Deviation 0.084

PRIMARY outcome

Timeframe: Week 8

Population: 7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.

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

Outcome measures

Measure	MC2-01 Cream n=7 Participants MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
Change in S-Calcium Metabolism at Week 8	-0.027 mmol/L Standard Deviation 0.060

PRIMARY outcome

Timeframe: Week 4

Population: 7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.

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

Outcome measures

Measure	MC2-01 Cream n=7 Participants MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
Change in U-Calcium Metabolism at Week 4	0.115 mol/mol Standard Deviation 0.426

PRIMARY outcome

Timeframe: Week 8

Population: 7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.

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

Outcome measures

Measure	MC2-01 Cream n=7 Participants MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
Change in U-Calcium Metabolism at Week 8	0.058 mol/mol Standard Deviation 0,186

SECONDARY outcome

Timeframe: Week 4

Population: The Maximum Plasma Concentration \[Cmax\] of the metabolite of BDP, betamethasone 17-propionate, was quantifiable in 3 out of 6 (50 %) participants only, thus the data only reflects result from 3 participants. The 3 remaining participants had values below Lower Limit of Quantification (LLOQ).

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

Outcome measures

Measure	MC2-01 Cream n=6 Participants MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
The Maximum Plasma Concentration [Cmax] of Betamethasone 17-propionate at Week 4	37.53 pg/mL Standard Deviation 22.82

SECONDARY outcome

Timeframe: Week 4

Population: The Maximum Plasma Concentration \[Cmax\] of the metabolite of BDP, betamethasone 17-propionate, was quantifiable in 3 out of 6 (50 %) participants only, thus the data only reflects result from 3 participants. The 3 remaining participants had values below Lower Limit of Quantification (LLOQ).

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

Outcome measures

Measure	MC2-01 Cream n=6 Participants MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks MC2-01 cream: MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
Time to Maximum Plasma Drug Concentration [Tmax] of Betamethasone 17-propionate at Week 4	2.333 Hours Standard Deviation 1.155

Adverse Events

MC2-01 Cream

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MC2-01 Cream n=7 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 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
Infections and infestations Nasopharyngitis	14.3% 1/7 • Number of events 1 • 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.
Infections and infestations Tonsillitis	14.3% 1/7 • Number of events 1 • 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.
Renal and urinary disorders Dysuria	14.3% 1/7 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Acne	14.3% 1/7 • Number of events 1 • 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.

Additional Information

Irene Sandholdt

MC2 Therapeutics

Phone: +45 2015 7033

Email: isa@mc2therapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60