Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis (NCT NCT03747575)

NCT ID: NCT03747575

Last Updated: 2023-05-06

Results Overview

The Eczema Area and Severity Index (EASI) is a standardized instrument to evaluate the extent and severity of atopic dermatitis. An area score comprised of the percentage of skin affected by eczema for each of 4 body regions (head/neck, trunk, upper extremities, and lower extremities) is calculated with 0 = none, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 90-100%. Severity is scored for each of the 4 body regions by the summation of the intensity scores for 4 signs (redness, thickness, scratching, and lichenification), with 0 = none/absent, 1 = mild, 2 = moderate, and 3 = severe. The minimum final EASI score is 0 and the maximum score is 72.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 65 participants
• Primary outcome timeframe: Baseline, Week 16
• Results posted on: 2023-05-06

Participant Flow

Participant milestones

Measure	Placebo Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.	Treatment Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).
Overall Study STARTED	32	33
Overall Study COMPLETED	23	26
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Measure	Placebo Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.	Treatment Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).
Overall Study Withdrawal by Subject	6	3
Overall Study Lost to Follow-up	3	3
Overall Study Adverse Event	0	1

Baseline Characteristics

A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis

Baseline characteristics by cohort

Measure	Placebo n=32 Participants Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.	Treatment n=33 Participants Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	39.3 Years STANDARD_DEVIATION 14.4 • n=5 Participants	39.7 Years STANDARD_DEVIATION 15.2 • n=7 Participants	39.5 Years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	25 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization.

The Eczema Area and Severity Index (EASI) is a standardized instrument to evaluate the extent and severity of atopic dermatitis. An area score comprised of the percentage of skin affected by eczema for each of 4 body regions (head/neck, trunk, upper extremities, and lower extremities) is calculated with 0 = none, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 90-100%. Severity is scored for each of the 4 body regions by the summation of the intensity scores for 4 signs (redness, thickness, scratching, and lichenification), with 0 = none/absent, 1 = mild, 2 = moderate, and 3 = severe. The minimum final EASI score is 0 and the maximum score is 72.

Outcome measures

Measure	Treatment n=33 Participants Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).	Placebo n=32 Participants Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.
Percent Change of Total Eczema Area and Severity Index (EASI) Score	-51.47 Percentage Standard Error 8.639	-58.24 Percentage Standard Error 9.092

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization.

Outcome measures

Measure	Treatment n=33 Participants Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).	Placebo n=32 Participants Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.
Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1	15.2 Percentage	6.3 Percentage

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization.

Outcome measures

Measure	Treatment n=33 Participants Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).	Placebo n=32 Participants Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.
Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score	27.3 Percentage	18.8 Percentage

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization.

The Peak Pruritis Numerical Rating Scale (NRS) is a single-item patient-reported outcome (PRO) of itch severity rated on a scale of 0-10, with 0 = no itch and 10 = worst itch imaginable for the prior 24-hour period.

Outcome measures

Measure	Treatment n=33 Participants Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).	Placebo n=32 Participants Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.
Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS)	-31.22 Percentage Standard Error 7.376	-39.43 Percentage Standard Error 7.839

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization.

Outcome measures

Measure	Treatment n=33 Participants Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).	Placebo n=32 Participants Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.
Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement	-42.23 Percentage Standard Error 8.637	-38.87 Percentage Standard Error 9.134

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population - all participants randomized on Day 1, grouped by the treatment assigned at randomization.

SCORAD is a tool used to assess the extent and severity of eczema based on three aspects of disease severity: extent, intensity, and a subjective (PRO) symptoms. A total score (0-103) is calculated, with higher scores indicating a higher extent and severity of symptoms.

Outcome measures

Measure	Treatment n=33 Participants Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).	Placebo n=32 Participants Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.
Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD)	-35.45 Percentage Standard Error 6.837	-39.50 Percentage Standard Error 7.202

SECONDARY outcome

Timeframe: Up to Week 24

Population: Safety population - all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received.

Outcome measures

Measure	Treatment n=34 Participants Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).	Placebo n=31 Participants Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.
Percentage of Participants With Adverse Events (AE)	14 Participants	18 Participants

SECONDARY outcome

Timeframe: At pre-defined intervals from baseline up to Week 24

Population: PK population: The PK population included participants from the safety population with at least one available post-study treatment PK sample.

Outcome measures

Measure	Treatment n=33 Participants Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).	Placebo Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.
Serum Concentrations of MSTT1041A Day 1 Visit 2/prior to infusion	NA ug/mL Geometric Coefficient of Variation NA Summary statistics are not reportable for sampling time points in which more than one-third of the samples were less than reportable (LTR; the value of LTR was set to zero).	—
Serum Concentrations of MSTT1041A Week 1 Visit 3/prior to infusion	42.6 ug/mL Geometric Coefficient of Variation 34.4	—
Serum Concentrations of MSTT1041A Week 4 Visit 5/prior to infusion	37.6 ug/mL Geometric Coefficient of Variation 52.5	—
Serum Concentrations of MSTT1041A Week 8 Visit 7/prior to infusion	36.6 ug/mL Geometric Coefficient of Variation 54.5	—
Serum Concentrations of MSTT1041A Week 12 Visit 9/prior to infusion	40.1 ug/mL Geometric Coefficient of Variation 60.5	—
Serum Concentrations of MSTT1041A Week 16 Visit 11	38.2 ug/mL Geometric Coefficient of Variation 76.0	—
Serum Concentrations of MSTT1041A Subject disposition - period completion/early discontinuation	7.83 ug/mL Geometric Coefficient of Variation 151.2	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: Safety population - all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received.

Outcome measures

Measure	Treatment n=34 Participants Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).	Placebo n=31 Participants Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.
Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs)	1 Participants	0 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Treatment

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=31 participants at risk Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.	Treatment n=34 participants at risk Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).
Vascular disorders Aortic aneurysm	0.00% 0/31 • Up to Week 24 The safety population contained all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received.	2.9% 1/34 • Number of events 1 • Up to Week 24 The safety population contained all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received.

Other adverse events

Measure	Placebo n=31 participants at risk Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.	Treatment n=34 participants at risk Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).
Gastrointestinal disorders Abdominal pain	6.5% 2/31 • Number of events 2 • Up to Week 24 The safety population contained all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received.	0.00% 0/34 • Up to Week 24 The safety population contained all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received.
Infections and infestations Nasopharyngitis	9.7% 3/31 • Number of events 5 • Up to Week 24 The safety population contained all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received.	0.00% 0/34 • Up to Week 24 The safety population contained all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received.
Skin and subcutaneous tissue disorders Dermatitis atopic	16.1% 5/31 • Number of events 6 • Up to Week 24 The safety population contained all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received.	8.8% 3/34 • Number of events 3 • Up to Week 24 The safety population contained all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 1-800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER