Chronic Spontaneous UrticariaPhase 2NCT05335499
A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria
A Phase 2 study testing TAS5315 Dose 1, TAS5315 Dose 2 and TAS5315 Dose 3 in people with Chronic Spontaneous Urticaria, run by Taiho Pharmaceutical Co., Ltd. at 12 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines 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?
- TAS5315 Dose 1, TAS5315 Dose 2 and TAS5315 Dose 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 12 sitesJapan
- Study dates
- 28 Jun 2022to 22 Dec 2023
- 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
- Aged 18 to 75 years
- Diagnosis of chronic spontaneous urticaria (CSU)
- Presence of itch and hives for at least 6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines for CSU
- UAS7 score ≥ 16 and HSS7 score ≥ 8 during 7 days prior to study entry
- In-clinic UAS ≥ 4 on study entry
- Willing and able to complete and Participate Daily for the duration of the study
Who cannot join
- Diseases other than CSU with symptoms of urticaria or angioedema, including urticarial vasculitis, erythema multiforme, mastocytosis, or hereditary or acquired angioedema
- Atopic dermatitis, psoriasis, ichthyosis, or other skin disease associated with chronic itching
- Bleeding diathesis
- Uncontrolled hypertension disease states
- Treatment with omalizumab or other humanized anti-human IgE monoclonal antibody therapies used to treat CSU within 4 months prior to screening
- Nonresponse to omalizumab or other humanized anti-human IgE monoclonal antibody therapies
- Have been treated with other Bruton's Tyrosine Kinase inhibitors
- Pregnant or lactating women
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
A site selected by Taiho Pharmaceutical Co., Ltd.
Ehime
A site selected by Taiho Pharmaceutical Co., Ltd.
Fukuoka
A site selected by Taiho Pharmaceutical Co., Ltd.
Gunma
A site selected by Taiho Pharmaceutical Co., Ltd.
Hiroshima
A site selected by Taiho Pharmaceutical Co., Ltd.
Ishikawa
A site selected by Taiho Pharmaceutical Co., Ltd.
Kagawa
A site selected by Taiho Pharmaceutical Co., Ltd.
Kumamoto
A site selected by Taiho Pharmaceutical Co., Ltd.
Obihiro
A site selected by Taiho Pharmaceutical Co., Ltd.
Osaka
A site selected by Taiho Pharmaceutical Co., Ltd.
Sapporo
A site selected by Taiho Pharmaceutical Co., Ltd.
Tokyo
A site selected by Taiho Pharmaceutical Co., Ltd.
Yokohama
About this study
Official title: A Phase 2a, Randomized, Double-blind, Study of TAS5315 in Chronic Spontaneous Urticaria Patients With an Inadequate Response to H1-antihistamines
The purpose of this study is to evaluate the efficacy and safety of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines
Read the detailed description
The main purpose of this study is to assess the efficacy of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines compared with placebo as measured by the change from baseline in weekly Urticaria Activity Score (UAS7) at week 12
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- TAS5315 Dose 1, TAS5315 Dose 2, TAS5315 Dose 3, TAS5315 Dose 4, TAS5315 Dose 5
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS5315 Dose 1Drug
Treatment period: oral administration for 12 weeks, QD
TAS5315 Dose 2Drug
Treatment period: oral administration for 12 weeks, QD
TAS5315 Dose 3Drug
Treatment period: oral administration for 12 weeks, QD
TAS5315 Dose 4Drug
Treatment period: oral administration for 12 weeks, QD
TAS5315 Dose 5Drug
Treatment period: oral administration for 12 weeks, QD
PlaceboDrug
- Screening period: oral administration for 2 weeks, QD
- Treatment period: oral administration for 12 weeks, QD
| Study group | Role | What they receive |
|---|---|---|
| TAS5315 Dose 1 | Experimental | Not described Receives: Drug: TAS5315 Dose 1 |
| TAS5315 Dose 2 | Experimental | Not described Receives: Drug: TAS5315 Dose 2 |
| TAS5315 Dose 3 | Experimental | Not described Receives: Drug: TAS5315 Dose 3 |
| AS5315 Dose 4 | Experimental | Not described Receives: Drug: TAS5315 Dose 4 |
| TAS5315 Dose 5 | Experimental | Not described Receives: Drug: TAS5315 Dose 5 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12
The UAS7 is the sum of the HSS7 score (weekly Hives Severity Sore) and the ISS7 score (weekly Itch Severity Score). The range of the UAS7 score is 0 - 42.
(Zuberbier et al. 1995; Zuberbier et al., 2014)
Measured: Week 12
Secondary outcomes (6)
Complete absence of hives and itch (UAS7=0)
Measured: Over time from week 1 to week 12
Disease control (UAS7<=6)
Measured: Over time from week 1 to week 12
Mean change from baseline in weekly Angioedema Activity Score (AAS7)
The AAS is a validated tool to assess occurrence of episodes of angioedema. The AAS7 is a weekly AAS score (AAS7). Minimum and maximum possible AAS7 scores are 0-105.
Measured: Over time from week 1 to week 12
Mean change from baseline in Dermatology life quality index (DLQI)
DLQI is a 10-item dermatology-specific quality of life (QoL) measure. The range of the DLQI score is 0 - 30.
Measured: Over time from week 1 to week 12
Mean change from baseline in Urticaria control test (UCT)
UCT is 4-item measure, which assesses symptoms, quality of life, treatment effectiveness. The range of the UCT score is 0 - 16.
Measured: Over time from week 1 to week 12
Mean change from baseline in pharmacodynamics marker
Pharmacodynamics marker are IgG, IgM, IgA, IgE, CRP and D-dimer.
Measured: Over time from week 1to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start28 Jun 2022
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taiho Pharmaceutical Co., Ltd., Study director, Taiho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335499
- Sponsor's protocol ID
- 10063040
- Status last verified
- Feb 2024
- First submitted
- 12 Apr 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Taiho provides a platform for accepting researchers' requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018.
Publications
Zuberbier T, Chantraine-Hess S, Hartmann K, Czarnetzki BM. Pseudoallergen-free diet in the treatment of chronic urticaria. A prospective study. Acta Derm Venereol. 1995 Nov;75(6):484-7. doi: 10.2340/0001555575484487.
PubMed 8651031Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, Brzoza Z, Canonica GW, Church MK, Ensina LF, Gimenez-Arnau A, Godse K, Goncalo M, Grattan C, Hebert J, Hide M, Kaplan A, Kapp A, Abdul Latiff AH, Mathelier-Fusade P, Metz M, Nast A, Saini SS, Sanchez-Borges M, Schmid-Grendelmeier P, Simons FE, Staubach P, Sussman G, Toubi E, Vena GA, Wedi B, Zhu XJ, Maurer M; European Academy of Allergy and Clinical Immunology; Global Allergy and Asthma European Network; European Dermatology Forum; World Allergy Organization. The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy. 2014 Jul;69(7):868-87. doi: 10.1111/all.12313. Epub 2014 Apr 30.
PubMed 24785199
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Study of TAS5315 in Chronic Spontaneous Urticaria Patients With an Inadequate Response to H1-antihistamines
- ClinicalTrials.gov ID
- NCT05335499
- Acronym / sponsor ID
- 10063040
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 19 Apr 2022 (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.
The purpose of this study is to evaluate the efficacy and safety of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines
Detailed description
The main purpose of this study is to assess the efficacy of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines compared with placebo as measured by the change from baseline in weekly Urticaria Activity Score (UAS7) at week 12
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TAS5315 Dose 1 | Experimental | Drug: TAS5315 Dose 1 |
| TAS5315 Dose 2 | Experimental | Drug: TAS5315 Dose 2 |
| TAS5315 Dose 3 | Experimental | Drug: TAS5315 Dose 3 |
| AS5315 Dose 4 | Experimental | Drug: TAS5315 Dose 4 |
| TAS5315 Dose 5 | Experimental | Drug: TAS5315 Dose 5 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 75 years
- Diagnosis of chronic spontaneous urticaria (CSU)
- Presence of itch and hives for at least 6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines for CSU
- UAS7 score ≥ 16 and HSS7 score ≥ 8 during 7 days prior to study entry
- In-clinic UAS ≥ 4 on study entry
Key exclusion criteria (8 listed)
- Diseases other than CSU with symptoms of urticaria or angioedema, including urticarial vasculitis, erythema multiforme, mastocytosis, or hereditary or acquired angioedema
- Atopic dermatitis, psoriasis, ichthyosis, or other skin disease associated with chronic itching
- Bleeding diathesis
- Uncontrolled hypertension disease states
- Treatment with omalizumab or other humanized anti-human IgE monoclonal antibody therapies used to treat CSU within 4 months prior to screening
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 |
|---|---|---|
| TAS5315 Dose 1Treatment period: oral administration for 12 weeks, QD | Drug | TAS5315 Dose 1 |
| TAS5315 Dose 2Treatment period: oral administration for 12 weeks, QD | Drug | TAS5315 Dose 2 |
| TAS5315 Dose 3Treatment period: oral administration for 12 weeks, QD | Drug | TAS5315 Dose 3 |
| TAS5315 Dose 4Treatment period: oral administration for 12 weeks, QD | Drug | AS5315 Dose 4 |
| TAS5315 Dose 5Treatment period: oral administration for 12 weeks, QD | Drug | TAS5315 Dose 5 |
| Placebo* Screening period: oral administration for 2 weeks, QD * Treatment period: oral administration for 12 weeks, QD | Drug | Placebo |
Primary outcome
Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12
Time frame: Week 12
The UAS7 is the sum of the HSS7 score (weekly Hives Severity Sore) and the ISS7 score (weekly Itch Severity Score). The range of the UAS7 score is 0 - 42. (Zuberbier et al. 1995; Zuberbier et al., 2014)
6 secondary outcomes
Complete absence of hives and itch (UAS7=0)
Time frame: Over time from week 1 to week 12
Disease control (UAS7<=6)
Time frame: Over time from week 1 to week 12
Mean change from baseline in weekly Angioedema Activity Score (AAS7)
Time frame: Over time from week 1 to week 12
Mean change from baseline in Dermatology life quality index (DLQI)
Time frame: Over time from week 1 to week 12
Mean change from baseline in Urticaria control test (UCT)
Time frame: Over time from week 1 to week 12
Mean change from baseline in pharmacodynamics marker
Time frame: Over time from week 1to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 8651031Zuberbier T, Chantraine-Hess S, Hartmann K, Czarnetzki BM. Pseudoallergen-free diet in the treatment of chronic urticaria. A prospective study. Acta Derm Venereol. 1995 Nov;75(6):484-7. doi: 10.2340/0001555575484487.
- Background: PubMed 24785199Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, Brzoza Z, Canonica GW, Church MK, Ensina LF, Gimenez-Arnau A, Godse K, Goncalo M, Grattan C, Hebert J, Hide M, Kaplan A, Kapp A, Abdul Latiff AH, Mathelier-Fusade P, Metz M, Nast A, Saini SS, Sanchez-Borges M, Schmid-Grendelmeier P, Simons FE, Staubach P, Sussman G, Toubi E, Vena GA, Wedi B, Zhu XJ, Maurer M; European Academy of Allergy and Clinical Immunology; Global Allergy and Asthma European Network; European Dermatology Forum; World Allergy Organization. The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy. 2014 Jul;69(7):868-87. doi: 10.1111/all.12313. Epub 2014 Apr 30.
- Copyright for UAS: Global Allergy and Asthma European Network (GA²LEN).Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Taiho provides a platform for accepting researchers' requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018.
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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.
Taiho Pharmaceutical Co., Ltd. study director
Taiho Pharmaceutical Co., Ltd.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAS5315 Dose 1, TAS5315 Dose 2 and TAS5315 Dose 3 in people with Chronic Spontaneous Urticaria, run by Taiho Pharmaceutical Co., Ltd. at 12 sites in Japan.
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 6 inclusion and 8 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 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05335499, which also lists 2 linked publications.
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 7 Aug 2024.