PsoriasisEarly Phase 1NCT04414605
Oral Chinese Herbal Medicine Concurrent With Secukinumab for Severe Plaque Psoriasis
A Early Phase 1 study testing Gu Ben Hua Yu Fang decoction (Chinese herbal medicine) and Secukinumab Auto-Injector [Cosentyx] in people with Psoriasis, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
The aim of this study is to determine whether oral Chinese herbal medicine in combination secukinumab is effective and safe in the treatment of severe psoriasis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis
- What is being tested?
- Gu Ben Hua Yu Fang decoction (Chinese herbal medicine) and Secukinumab Auto-Injector [Cosentyx]
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2020to 31 Dec 2021
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Psoriasis Area and Severity Index (PASI) score≥10
- Meet the requirement of using secukinumab; without the history of inflammatory bowel disease (IBD)
- Written/signed informed consent
Who cannot join
- 1. Unsuitable for the treatment of secukinumab
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510000
Chuanjian Lu, PhD, (8620)81887233 ext. 31223, luchuanjian888@vip.sina.com
Zehuai Wen, PhD, （86）13903008091, wenzehuai@139.com
About this study
Official title: Oral Chinese Herbal Medicine Formula (Gu Ben Hua Yu Fang) Concurrent With Secukinumab for Severe Plaque Psoriasis
The aim of this study is to determine whether oral Chinese herbal medicine in combination secukinumab is effective and safe in the treatment of severe psoriasis.
Read the detailed description
The aim of this study is to determine whether oral Chinese herbal medicine in combination with secukinumab is effective and safe in the treatment of severe psoriasis. Eligible participants will be treated with oral Chinese herbal medicine and secukinumab concurrently. No controlled group will be set up in this trial. The primary outcome is time to relapse. Secondary outcomes include Psoriasis Area and Severity Index (PASI) 75/90, PASI score reduction rate, physician's global assessment (PGA) score, body surface area (BSA) score, visual analogue scale (VAS) score, dermatology life quality index (QLQI) and Skindex 16.
- Conditions
- Psoriasis
- Being tested
- Gu Ben Hua Yu Fang decoction (Chinese herbal medicine), Secukinumab Auto-Injector [Cosentyx]
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gu Ben Hua Yu Fang decoction (Chinese herbal medicine)Drug
Also called Chinese herbal medicine decoction
Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice daily. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection.
Secukinumab Auto-Injector [Cosentyx]Drug
Also called Cosentyx
Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg).
| Study group | Role | What they receive |
|---|---|---|
| Chinese herbal medicine in combination with secukinumab | Experimental | Oral Chinese herbal medicine (Gu Ben Hua Yu Fang decoction) and secukinumab will be used concurrently. The treatment duration for both secukinumab and oral Chinese herbal medicine is up to 16 weeks. Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg). Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice a day. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection. Receives: Drug: Gu Ben Hua Yu Fang decoction (Chinese herbal medicine); Drug: Secukinumab Auto-Injector [Cosentyx] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median time to relapse
Median time to relapse is a time interval. The time interval will be recorded between the end of treatment and the occurrence of relapse. Relapse was defined as loss of > 50% of maximum Psoriasis Area and Severity Index (PASI) improvement compared with pretreatment baseline.
Measured: Through study completion, an average of 1 year
Secondary outcomes (9)
Psoriasis Area and Severity Index (PASI) score
The improvement in Psoriasis Area and Severity Index (PASI) score from baseline after treatment; the scale scores ranged from 0-72. The higher the scores are, the more severe the patients suffer
Measured: Assessment will be conducted at week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year
PASI-75
The proportion of patients who achieve at least 75% improvement in PASI score from baseline.
Measured: 16 weeks after treatment
PASI-90
The proportion of patients who achieve at least 90% improvement in PASI score from baseline.
Measured: 16 weeks after treatment
Physician's global assessment (PGA) score
Physician's global assessment for the condition
Measured: Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.
Pruritus Scores on the Visual Analogue Scale
Pruritus will be assessed using the Visual Analogue Scales; The Scale scores ranged from 0-10; the higher the scores are, the more itching the patients suffer.
Measured: Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.
BSA
the Body Surface Area
Measured: Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.
Dermatology Life Quality Index (DLQI)
Questionnaire for disease-specific quality of life
Measured: Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
Skindex16
Questionnaire for disease-specific quality of life
Measured: Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
patients' attitudes, expectation and experience
Semi-structured individual interview will be conducted to explore patients' understanding and expectation for the combination therapy used in this study. Patients' experience of using the combination therapy will be recorded as well.
Measured: Interview will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start4 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Chuanjian Lu, PhD, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414605
- Sponsor's protocol ID
- BF2020-068-02
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Chinese Herbal Medicine Formula (Gu Ben Hua Yu Fang) Concurrent With Secukinumab for Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04414605
- Acronym / sponsor ID
- BF2020-068-02
- Conditions
- Psoriasis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 Jun 2020 (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 aim of this study is to determine whether oral Chinese herbal medicine in combination secukinumab is effective and safe in the treatment of severe psoriasis.
Detailed description
The aim of this study is to determine whether oral Chinese herbal medicine in combination with secukinumab is effective and safe in the treatment of severe psoriasis. Eligible participants will be treated with oral Chinese herbal medicine and secukinumab concurrently. No controlled group will be set up in this trial. The primary outcome is time to relapse. Secondary outcomes include Psoriasis Area and Severity Index (PASI) 75/90, PASI score reduction rate, physician's global assessment (PGA) score, body surface area (BSA) score, visual analogue scale (VAS) score, dermatology life quality index (QLQI) and Skindex 16.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese herbal medicine in combination with secukinumab | Experimental | Drug: Gu Ben Hua Yu Fang decoction (Chinese herbal medicine), Drug: Secukinumab Auto-Injector [Cosentyx]Oral Chinese herbal medicine (Gu Ben Hua Yu Fang decoction) and secukinumab will be used concurrently. The treatment duration for both secukinumab and oral Chinese herbal medicine is up to 16 weeks. Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg). Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice a day. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Psoriasis Area and Severity Index (PASI) score≥10
- Meet the requirement of using secukinumab; without the history of inflammatory bowel disease (IBD)
- Written/signed informed consent
Key exclusion criteria (1 listed)
- 1. Unsuitable for the treatment of secukinumab
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 |
|---|---|---|
| Gu Ben Hua Yu Fang decoction (Chinese herbal medicine)Also: Chinese herbal medicine decoctionChinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice daily. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection. | Drug | Chinese herbal medicine in combination with secukinumab |
| Secukinumab Auto-Injector [Cosentyx]Also: CosentyxSecukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg). | Drug | Chinese herbal medicine in combination with secukinumab |
Primary outcome
Median time to relapse
Time frame: Through study completion, an average of 1 year
Median time to relapse is a time interval. The time interval will be recorded between the end of treatment and the occurrence of relapse. Relapse was defined as loss of > 50% of maximum Psoriasis Area and Severity Index (PASI) improvement compared with pretreatment baseline.
9 secondary outcomes
Psoriasis Area and Severity Index (PASI) score
Time frame: Assessment will be conducted at week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year
PASI-75
Time frame: 16 weeks after treatment
PASI-90
Time frame: 16 weeks after treatment
Physician's global assessment (PGA) score
Time frame: Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.
Pruritus Scores on the Visual Analogue Scale
Time frame: Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.
BSA
Time frame: Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.
Dermatology Life Quality Index (DLQI)
Time frame: Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
Skindex16
Time frame: Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
patients' attitudes, expectation and experience
Time frame: Interview will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
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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.
Chuanjian Lu, PhD principal investigator
Guangdong Provincial Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gu Ben Hua Yu Fang decoction (Chinese herbal medicine) and Secukinumab Auto-Injector [Cosentyx] in people with Psoriasis, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuanjian Lu, PhD (+8620-81887233 ext. 31223, luchuanjian888@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median time to relapse (time frame: Through study completion, an average of 1 year). 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 2 Mar 2021.