Systemic Lupus ErythematosusPhase 2NCT03396393
Exploratory Study of DHA in Systemic Lupus Erythematosus Patients
A Phase 2 study testing Dihydroartemisinin tablet in people with Systemic Lupus Erythematosus, run by Kunming Pharmaceuticals, Inc..
Trial summary
The primary objective of the study is to assess the efficacy of DHA in patients with SLE. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Dihydroartemisinin tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Dec 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology;
- Positive antinuclear antibodies (ANA);
- Activity Index (SLEDAI) score must be 6-11 points, inclusive;
- Stable dose of prednisone (<30mg/d) for at least one month ;
- Active mild to moderate SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG);
- Males or females between 18 and 65 years old;
- Weight of 45 kg or greater.
Who cannot join
- Active Severe Lupus as defined by BILAG Index Level A or two or more of Level B in any body system/organ;
- Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections;
- Presence of active central nervous system (CNS) disease requiring treatment;
- Subjects with active, severe SLE disease activity which involves the renal system;
- Substance abuse or dependence;
- History of malignant cancer within the last 5 years;
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- Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion;
- Subjects received any live vaccination within the 30 days prior to Visit 2;
- Subjects received intravenous immunoglobulin (IVIg) or,plasmapheresis,or High dose prednisone or equivalent (> 100 mg/day) within 90 days prior to Visit 2;
- Subjects who have had therapy with cyclophosphamide within 180 days prior to Visit 2 .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Efficacy of Dihydroartemisinin Tablets in Patients With Systemic Lupus Erythematosus
The primary objective of the study is to assess the efficacy of DHA in patients with SLE.
Read the detailed description
This is a Phase 2, multicentre, randomised, double-blind, placebo-controlled study to evaluate the Safety, Pharmacokinetics and Efficacy of four oral treatment regimens of DHA versus placebo while taking standard of care (SOC) treatment with corticosteroids in adult subjects with Systemic Lupus Erythematosus (SLE).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Dihydroartemisinin tablet, Placebo tablet
- Keywords
- Dihydroartemisinin;Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin tabletDrug
Also called No other names
DHA tablet
Placebo tabletDrug
Also called No other names
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Dihydroartemisinin 40mg | Experimental | Randomized 30 patients will be received Dihydroartemisinin tablets 40mg in oral continuously from Week 0 to Week 24 in addition to SOC. Receives: Drug: Dihydroartemisinin tablet |
| Dihydroartemisinin 80mg | Experimental | Randomized 30 patients will be received Dihydroartemisinin tablets 80mg in oral continuously from Week 0 to Week 24 in addition to SOC. Receives: Drug: Dihydroartemisinin tablet |
| Dihydroartemisinin 120mg | Experimental | Randomized 30 patients will be received Dihydroartemisinin tablets 120mg in oral continuously from Week 0 to Week 24 in addition to SOC. Receives: Drug: Dihydroartemisinin tablet |
| placebo | Placebo comparator | Randomized 30 patients will be received placebo tablets in oral continuously from Week 0 to Week 24 in addition to SOC. Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
SRI,Response at Week 24 according to a combined response index
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
Measured: week 24
Secondary outcomes (4)
Change from baseline in SLEDAI score
Change from baseline in SLEDAI score at week 4,8,12,16,20,24
Measured: week 4,8,12,16,20,24
Change from baseline in PAG score
Change from baseline in PAG score at week 4,8,12,16,20,24
Measured: week 4,8,12,16,20,24
Number of days of daily prednisone dose Less than or equal to 7.5 mg/day
Number of days of daily prednisone dose Less than or equal to 7.5 mg/day from baseline over 24 weeks
Measured: Baseline, Week 24
Percent of subjects with UPRO <0.5g/24h
Percent of subjects with UPRO <0.5g/24h from baseline at Week 4,12,24
Measured: Week 4,12,24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study startMar 2018 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Model description
- Patients will be received DHA 40mg or DHA 80mg or DHA 120mg or placebo continuously for 24 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fengchun Zhang, Prof., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396393
- Sponsor's protocol ID
- KY41078-201
- Status last verified
- Jan 2018
- First submitted
- 4 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study has not been decided.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Efficacy of Dihydroartemisinin Tablets in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT03396393
- Acronym / sponsor ID
- KY41078-201
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Dihydroartemisinin;Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kunming Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2018 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Jan 2018 (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 primary objective of the study is to assess the efficacy of DHA in patients with SLE.
Detailed description
This is a Phase 2, multicentre, randomised, double-blind, placebo-controlled study to evaluate the Safety, Pharmacokinetics and Efficacy of four oral treatment regimens of DHA versus placebo while taking standard of care (SOC) treatment with corticosteroids in adult subjects with Systemic Lupus Erythematosus (SLE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Patients will be received DHA 40mg or DHA 80mg or DHA 120mg or placebo continuously for 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Dihydroartemisinin 40mg | Experimental | Drug: Dihydroartemisinin tabletRandomized 30 patients will be received Dihydroartemisinin tablets 40mg in oral continuously from Week 0 to Week 24 in addition to SOC. |
| Dihydroartemisinin 80mg | Experimental | Drug: Dihydroartemisinin tabletRandomized 30 patients will be received Dihydroartemisinin tablets 80mg in oral continuously from Week 0 to Week 24 in addition to SOC. |
| Dihydroartemisinin 120mg | Experimental | Drug: Dihydroartemisinin tabletRandomized 30 patients will be received Dihydroartemisinin tablets 120mg in oral continuously from Week 0 to Week 24 in addition to SOC. |
| placebo | Placebo comparator | Drug: Placebo tabletRandomized 30 patients will be received placebo tablets in oral continuously from Week 0 to Week 24 in addition to SOC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology;
- Positive antinuclear antibodies (ANA);
- Activity Index (SLEDAI) score must be 6-11 points, inclusive;
- Stable dose of prednisone (<30mg/d) for at least one month ;
- Active mild to moderate SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG);
Key exclusion criteria (10 listed)
- Active Severe Lupus as defined by BILAG Index Level A or two or more of Level B in any body system/organ;
- Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections;
- Presence of active central nervous system (CNS) disease requiring treatment;
- Subjects with active, severe SLE disease activity which involves the renal system;
- Substance abuse or dependence;
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 |
|---|---|---|
| Dihydroartemisinin tabletAlso: No other namesDHA tablet | Drug | Dihydroartemisinin 120mg, Dihydroartemisinin 40mg, Dihydroartemisinin 80mg |
| Placebo tabletAlso: No other namesPlacebo tablet | Drug | placebo |
Primary outcome
SRI,Response at Week 24 according to a combined response index
Time frame: week 24
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
4 secondary outcomes
Change from baseline in SLEDAI score
Time frame: week 4,8,12,16,20,24
Change from baseline in PAG score
Time frame: week 4,8,12,16,20,24
Number of days of daily prednisone dose Less than or equal to 7.5 mg/day
Time frame: Baseline, Week 24
Percent of subjects with UPRO <0.5g/24h
Time frame: Week 4,12,24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: Undecided. This study has not been decided.
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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.
Fengchun Zhang, Prof. principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dihydroartemisinin tablet in people with Systemic Lupus Erythematosus, run by Kunming Pharmaceuticals, 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 7 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: status not confirmed, as of the sponsor's last update on 23 Jan 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinyan Li, Ph.D (+86-13817688857, xinyan.li@holley.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SRI,Response at Week 24 according to a combined response index (time frame: week 24). 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 23 Jan 2018.