Atopic DermatitisPhase 2NCT03747575
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing MSTT1041A in people with Atopic Dermatitis, run by Genentech, Inc. at 21 sites in 3 countries.
Trial summary
This study will assess the efficacy and safety of MSTT1041A (astegolimab) in participants with moderate to severe atopic dermatitis (AD). The study consists of a screening period, a 16-week treatment period, and an 8-week follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- MSTT1041A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 6 Feb 2019to 5 May 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to comply with the study protocol
- Chronic AD that has been present for at least 3 years before the screening visit
- Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications (medications or treatments applied directly to part of the body) or for whom topical treatments are otherwise medically inadvisable
Who cannot join
- Prior treatment with MSTT1041A
- Treatment with any investigational therapy (with the exception of biologics) within 8 weeks or within 5 half-lives whichever is longer, before screening
- Treatment with any cell-depleting agents within 6 months before screening, or until lymphocyte count returns to normal, whichever is longer
- Treatment with other biologics within 3 months or 5 half-lives before screening, whichever is longer
- Comorbid conditions that may interfere with evaluation of investigational medicinal product
- History or evidence of substance abuse that would pose a risk to participant safety, interfere with the conduct of the study, have an impact on the study results, or affect the participant's ability to participate in the study
Show all 10Show fewer
- History of anaphylaxis, hypersensitivity to a biologic agent, or known hypersensitivity to any component of the MSTT1041A or placebo injection
- Planned surgical intervention during the course of the study
- Pregnant or breastfeeding, or intending to become pregnant during the study
- Participant who is a member of the investigational team or his/her immediate family
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States15 sites
Alabama Allergy & Asthma
Birmingham, Alabama, 35209
Asthma & Allergy; Associates, P.C.
Colorado Springs, Colorado, 80907
Skin Laser and Surgery Specialists of New York and New Jersey LLC - Interspond - PPDS
Hackensack, New Jersey, 07601
Center for Clinical Studies
Houston, Texas, 77004
Clinical Research Consortium Nevada
Las Vegas, Nevada, 89119
California Allergy and Asthma Medical Group - CRN
Los Angeles, California, 90025
Jonathan Corren MD, Inc.
Los Angeles, California, 90025
Dermatology Specialists Research, LLC
Louisville, Kentucky, 40241
South Coast Research Center, Inc.
Miami, Florida, 33136
Midwest Sinus Allergy and Asthma - CRN
Normal, Illinois, 61761
Harmony Clinical Research, Inc
North Miami Beach, Florida, 33162
GCP Global Clinical Professionals
St. Petersburg, Florida, 33702
Forward Clinical Trials
Tampa, Florida, 33624
Vital Prospects Clinical Research Institute PC - CRN
Tulsa, Oklahoma, 74136
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, 32789
Poland5 sites
Centrum Medyczne ALL-MED
Krakow, 30-033
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90-153
Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina; Klinika Dermatologii
Rzeszów, 35-055
Laser Clinic
Szczecin, 70-322
Wro Medica
Wroc?aw, 51-685
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of MSTT1041A in Patients With Moderate to Severe Atopic Dermatitis
This study will assess the efficacy and safety of MSTT1041A (astegolimab) in participants with moderate to severe atopic dermatitis (AD). The study consists of a screening period, a 16-week treatment period, and an 8-week follow-up period.
- Conditions
- Atopic Dermatitis
- Being tested
- MSTT1041A, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSTT1041ADrug
Also called astegolimab
Participants will receive subcutaneous (SC) MSTT1041A
PlaceboDrug
Participants will receive SC placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants will receive MSTT1041A Receives: Drug: MSTT1041A |
| Placebo | Placebo comparator | Participants will receive placebo matched to MSTT1041A Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change of Total Eczema Area and Severity Index (EASI) Score
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.
Measured: Baseline, Week 16
Secondary outcomes (8)
Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1
Measured: Baseline, Week 16
Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score
Measured: Baseline, Week 16
Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS)
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.
Measured: Baseline, Week 16
Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement
Measured: Baseline, Week 16
Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD)
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.
Measured: Baseline, Week 16
Percentage of Participants With Adverse Events (AE)
Measured: Up to Week 24
Serum Concentrations of MSTT1041A
Measured: At pre-defined intervals from baseline up to Week 24
Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs)
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start6 Feb 2019
- Primary completion11 Mar 2020
- Study completion5 May 2020
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 Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747575
- Sponsor's protocol ID
- GS40965
- Other IDs
- 2018-003429-27, 2018
- Status last verified
- Apr 2023
- First submitted
- 16 Nov 2018
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of MSTT1041A in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03747575
- Acronym / sponsor ID
- GS40965
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Posted 6 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy and safety of MSTT1041A (astegolimab) in participants with moderate to severe atopic dermatitis (AD). The study consists of a screening period, a 16-week treatment period, and an 8-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: MSTT1041AParticipants will receive MSTT1041A |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to MSTT1041A |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to comply with the study protocol
- Chronic AD that has been present for at least 3 years before the screening visit
- Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications (medications or treatments applied directly to part of the body) or for whom topical treatments are otherwise medically inadvisable
Key exclusion criteria (10 listed)
- Prior treatment with MSTT1041A
- Treatment with any investigational therapy (with the exception of biologics) within 8 weeks or within 5 half-lives whichever is longer, before screening
- Treatment with any cell-depleting agents within 6 months before screening, or until lymphocyte count returns to normal, whichever is longer
- Treatment with other biologics within 3 months or 5 half-lives before screening, whichever is longer
- Comorbid conditions that may interfere with evaluation of investigational medicinal product
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 |
|---|---|---|
| MSTT1041AAlso: astegolimabParticipants will receive subcutaneous (SC) MSTT1041A | Drug | Treatment |
| PlaceboParticipants will receive SC placebo | Drug | Placebo |
Primary outcome
Percent Change of Total Eczema Area and Severity Index (EASI) Score
Time frame: Baseline, Week 16
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.
8 secondary outcomes
Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1
Time frame: Baseline, Week 16
Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score
Time frame: Baseline, Week 16
Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS)
Time frame: Baseline, Week 16
Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement
Time frame: Baseline, Week 16
Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD)
Time frame: Baseline, Week 16
Percentage of Participants With Adverse Events (AE)
Time frame: Up to Week 24
Serum Concentrations of MSTT1041A
Time frame: At pre-defined intervals from baseline up to Week 24
Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs)
Time frame: Up to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm
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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.
Clinical Trials study director
Genentech, Inc.
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MSTT1041A in people with Atopic Dermatitis, run by Genentech, Inc. at 21 sites in 3 countries.
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 3 inclusion and 10 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Poland, Germany. 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. Some participants in this study may receive a placebo. 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 6 May 2023). 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?
Percent Change of Total Eczema Area and Severity Index (EASI) Score (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.