Chronic Spontaneous UrticariaPhase 2NCT05129423
A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria
A Phase 2 study testing MTPS9579A in people with Chronic Spontaneous Urticaria, run by Genentech, Inc..
Trial summary
This pilot and dose-ranging study will evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A compared with placebo in participants with chronic spontaneous urticaria (CSU) refractory to antihistamines. This study comprises two parts. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- MTPS9579A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2022to 31 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Diagnosis of CSU refractory to sgH1-AHs at the time of randomization
- Demonstrated ability to comply with the required use of the eDiary for the duration of the study
- For patients on H2 antihistamines or LTRAs for non-CSU indications, treatment at a stable dose for >=2 weeks prior to screening, with no anticipated changes throughout duration of study, including the screening period
- For women of childbearing potential: agreement to remain abstinent or use contraception
- For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
Who cannot join
- Previous participation in a clinical trial of MTPS9579A
- Chronic urticaria with known cause or other disease with symptoms of urticaria or angioedema
- Other skin disease associated with chronic itching
- Uncontrolled disease where flares are commonly treated with systemic corticosteroids
- History or evidence of any clinically significant medical condition/disease or abnormalities in laboratory tests that, in the investigator's judgment, preclude the patient's safe participation and completion of the study, or interferes with the conduct and interpretation of the study
- History of anaphylaxis without clearly identifiable avoidable antigen
- History of anaphylaxis to any biologic therapy for any indication
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot and Dose-Ranging Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria
This pilot and dose-ranging study will evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A compared with placebo in participants with chronic spontaneous urticaria (CSU) refractory to antihistamines. This study comprises two parts. In Part 1, participants will be randomized to receive MTPS9579A or placebo. On the basis of positive results from Part 1, a dose-ranging Part 2 may be opened, where participants will be randomized to receive one of four MTPS9579A doses or placebo.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- MTPS9579A, Placebo
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTPS9579ADrug
MTPS9579A will be administered.
PlaceboDrug
Placebo matched with MTPS9579A will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: MTPS9579A Dose A | Experimental | In Part 1, participants will receive MTPS9579A dose A every 4 weeks from randomization to Week 12. Receives: Drug: MTPS9579A |
| Part 1: Placebo | Placebo comparator | In Part 1, participants will receive placebo matched with MTPS9579A, every 4 weeks from randomization through Week 12. Receives: Drug: Placebo |
| Part 2: MTPS9579A Dose A | Experimental | In Part 2, participants will receive MTPS9579A dose A, every 4 weeks from randomization to Week 12. Receives: Drug: MTPS9579A |
| Part 2: MTPS9579A Dose B | Experimental | In Part 2, participants will receive MTPS9579A dose B, every 4 weeks from randomization to Week 12. Receives: Drug: MTPS9579A |
| Part 2: MTPS9579A Dose C | Experimental | In Part 2, participants will receive MTPS9579A dose C, every 4 weeks from randomization to Week 12. Receives: Drug: MTPS9579A |
| Part 2: MTPS9579A Dose D | Experimental | In Part 2, participants will receive MTPS9579A dose D, every 4 weeks from randomization to Week 12. Receives: Drug: MTPS9579A |
| Part 2: Placebo Dose A | Placebo comparator | In Part 2, participants will receive placebo matched with MTPS9579A dose A and B, every 4 weeks from randomization through Week 12. Receives: Drug: Placebo |
| Part 2: Placebo Dose B | Placebo comparator | In Part 2, participants will receive placebo matched with MTPS9579A dose C and D, every 4 weeks from randomization through Week 12. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the UAS7
Change from baseline in the Urticaria Activity Score summed over 7 days (UAS7) at Week 12.
Measured: Week 12
Secondary outcomes (6)
Proportion of Participants With Well-Controlled Urticaria
Proportion of participants with well-controlled urticaria (UAS7<=6) at Week 12.
Measured: Week 12
Proportion of Participants Who Achieve Complete Response
Proportion of participants who achieve complete response (UAS7=0) at Week 12.
Measured: Week 12
Percentage of Participants With Adverse Events
Percentage of participants with adverse events.
Measured: Up to approximately 96 weeks
Serum Concentration of MTPS9579A
Measured: Through Week 20
Prevalence of Anti-Drug Antibodies (ADAs)
Measured: Through Week 20
Incidence of ADAs
Measured: Through Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start31 Jul 2022 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Why it stopped: Development of MTPS9579A was terminated for strategic/business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129423
- Sponsor's protocol ID
- GA43512
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2021
- Last updated
- 18 Nov 2022
- Results posted
- No
- 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 Sharing of Clinical Study 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 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot and Dose-Ranging Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT05129423
- Acronym / sponsor ID
- GA43512
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Development of MTPS9579A was terminated for strategic/business reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2022 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot and dose-ranging study will evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A compared with placebo in participants with chronic spontaneous urticaria (CSU) refractory to antihistamines. This study comprises two parts. In Part 1, participants will be randomized to receive MTPS9579A or placebo. On the basis of positive results from Part 1, a dose-ranging Part 2 may be opened, where participants will be randomized to receive one of four MTPS9579A doses or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1: MTPS9579A Dose A | Experimental | Drug: MTPS9579AIn Part 1, participants will receive MTPS9579A dose A every 4 weeks from randomization to Week 12. |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboIn Part 1, participants will receive placebo matched with MTPS9579A, every 4 weeks from randomization through Week 12. |
| Part 2: MTPS9579A Dose A | Experimental | Drug: MTPS9579AIn Part 2, participants will receive MTPS9579A dose A, every 4 weeks from randomization to Week 12. |
| Part 2: MTPS9579A Dose B | Experimental | Drug: MTPS9579AIn Part 2, participants will receive MTPS9579A dose B, every 4 weeks from randomization to Week 12. |
| Part 2: MTPS9579A Dose C | Experimental | Drug: MTPS9579AIn Part 2, participants will receive MTPS9579A dose C, every 4 weeks from randomization to Week 12. |
| Part 2: MTPS9579A Dose D | Experimental | Drug: MTPS9579AIn Part 2, participants will receive MTPS9579A dose D, every 4 weeks from randomization to Week 12. |
| Part 2: Placebo Dose A | Placebo comparator | Drug: PlaceboIn Part 2, participants will receive placebo matched with MTPS9579A dose A and B, every 4 weeks from randomization through Week 12. |
| Part 2: Placebo Dose B | Placebo comparator | Drug: PlaceboIn Part 2, participants will receive placebo matched with MTPS9579A dose C and D, every 4 weeks from randomization through Week 12. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of CSU refractory to sgH1-AHs at the time of randomization
- Demonstrated ability to comply with the required use of the eDiary for the duration of the study
- For patients on H2 antihistamines or LTRAs for non-CSU indications, treatment at a stable dose for >=2 weeks prior to screening, with no anticipated changes throughout duration of study, including the screening period
- For women of childbearing potential: agreement to remain abstinent or use contraception
- For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
Key exclusion criteria (7 listed)
- Previous participation in a clinical trial of MTPS9579A
- Chronic urticaria with known cause or other disease with symptoms of urticaria or angioedema
- Other skin disease associated with chronic itching
- Uncontrolled disease where flares are commonly treated with systemic corticosteroids
- History or evidence of any clinically significant medical condition/disease or abnormalities in laboratory tests that, in the investigator's judgment, preclude the patient's safe participation and completion of the study, or interferes with the conduct and interpretation of the study
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 |
|---|---|---|
| MTPS9579AMTPS9579A will be administered. | Drug | Part 1: MTPS9579A Dose A, Part 2: MTPS9579A Dose A, Part 2: MTPS9579A Dose B, Part 2: MTPS9579A Dose C, Part 2: MTPS9579A Dose D |
| PlaceboPlacebo matched with MTPS9579A will be administered. | Drug | Part 1: Placebo, Part 2: Placebo Dose A, Part 2: Placebo Dose B |
Primary outcome
Change From Baseline in the UAS7
Time frame: Week 12
Change from baseline in the Urticaria Activity Score summed over 7 days (UAS7) at Week 12.
6 secondary outcomes
Proportion of Participants With Well-Controlled Urticaria
Time frame: Week 12
Proportion of Participants Who Achieve Complete Response
Time frame: Week 12
Percentage of Participants With Adverse Events
Time frame: Up to approximately 96 weeks
Serum Concentration of MTPS9579A
Time frame: Through Week 20
Prevalence of Anti-Drug Antibodies (ADAs)
Time frame: Through Week 20
Incidence of ADAs
Time frame: Through Week 20
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- 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 Sharing of Clinical Study 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
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MTPS9579A in people with Chronic Spontaneous Urticaria, run by Genentech, Inc..
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 7 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: withdrawn, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change From Baseline in the UAS7 (time frame: Week 12). 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 18 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.