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Systemic Lupus ErythematosusPhase 1/2NCT04305197

A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)

A Phase 1/2 study testing ICP-022 in people with Systemic Lupus Erythematosus, run by Beijing InnoCare Pharma Tech Co., Ltd. at 11 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to assess the Safety, Tolerability, PK/PD and preliminary Efficacy of ICP-022 in Subjects with Systemic Lupus Erythematosus (SLE) Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
ICP-022
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
11 sitesChina
Study dates
9 Jul 2020to 28 Apr 2022
Phase
Phase 1/2
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

  • Male or female subjects aged 18 to 75
  • diagnosis of with SLE at least 6 months at screening visit
  • SLEDAE-2K≥5
  • Is receiving standard treatment for SLE and has been receiving treatment for at least 3 months.
  • At least one SLE activity manifestation (as assessed by SLEDAE-2K)

Who cannot join

  • Failure to comply with the requirements of the programme
  • A female or male partner who is pregnant or breastfeeding or who plans to become pregnant during the study period
  • Previously treated with a BTK inhibitor
  • Neuropsychiatric lupus (NPSLE)
  • Has other autoimmune diseases other than SLE
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100000

  • Peking University third hospital

    Beijing, Beijing Municipality, 100000

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • Guangdong General Hospital

    Guangzhou, Guangdong

  • Gulou Hospital Affiliated to Medical College of Nanjing University

    Nanjing, Jiangsu, 210000

  • Huashan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

  • University of Hong Kong Shenzhen Hospital

    Shenzhen, Guangdong

  • The First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase Ib/IIa Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerance, Pharmacokinetics/ Pharmacodynamics(PK/PD) of ICP-022 in Patients With Mild and Moderate Systemic Lupus Erythematosus

The purpose of the study is to assess the Safety, Tolerability, PK/PD and preliminary Efficacy of ICP-022 in Subjects with Systemic Lupus Erythematosus (SLE)

Being tested
ICP-022, Placebos
Keywords
Mild to Moderate
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.

  • ICP-022Drug

    Also called Orelabrutinib

    Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period

  • ICP-022Drug

    Also called Orelabrutinib

    Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period

  • ICP-022Drug

    Also called Orelabrutinib

    Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period

  • PlacebosDrug

    Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period

Study groups in NCT04305197
Study groupRoleWhat they receive
Lower DoseExperimentalNot described
Receives: Drug: ICP-022
Medium DoseExperimentalNot described
Receives: Drug: ICP-022
Higher DoseExperimentalNot described
Receives: Drug: ICP-022
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Up to 28 Days after the last dose of study drug

  2. Number of Patients with Treatment-emergent Adverse Event(TEAEs) according to severity

    Measured: Up to 28 Days after the last dose of study drug

  3. Number of participants with clinically significant physical examination abnormalities

    Measured: Up to 28 Days after the last dose of study drug

  4. Number of participants with clinically significant vital signs abnormalities

    Measured: Up to 28 Days after the last dose of study drug

  5. Number of participants with clinically significant ECG abnormalities

    Measured: Up to 28 Days after the last dose of study drug

  6. Number of participants with clinically significant laboratory examination abnormalities

    Measured: Up to 28 Days after the last dose of study drug

Secondary outcomes (17)

  1. Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4)

    Measured: 12 Weeks

  2. Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6)

    Measured: 12 Weeks

  3. Occupancy rate of Bruton Tyrosine Kinase(BTK)

    Measured: 14 Days

  4. Serum Immunoglobulin (Ig) level

    Measured: 12 Weeks

  5. Changes from Baseline in Ig levels

    Measured: 12 Weeks

  6. Changes from Baseline in C3

    Measured: 12 Weeks

  7. Changes from Baseline in C4

    Measured: 12 Weeks

  8. Changes from Baseline in serum dsDNA

    Measured: 12 Weeks

  9. Changes from Baseline in Anti-nuclear Antibodies

    Measured: 12 Weeks

  10. Changes from Baseline in Interferon-α(INF-α) level

    Changes from Baseline in cytokine levels

    Measured: 12 Weeks

  11. Changes from Baseline in Interleukin-6(IL-6) level

    Changes from Baseline in cytokine levels

    Measured: 12 Weeks

  12. Changes from Baseline in total B cell counts

    Measured: 12 Weeks

  13. Change from Baseline in Beffs count

    Measured: 12 Weeks

  14. Changes from baseline in Bregs count

    Measured: 12 Weeks

  15. Changes from Baseline in Bregs to Beffs ratio

    Measured: 12 Weeks

  16. Changes from Baseline in Erythrocyte Sedimentation Rate(ESR)

    Measured: 12 Weeks

  17. The plasma concentration-time curve

    Measured: 14 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2020
  2. Study start9 Jul 2020
  3. Primary completion28 Apr 2022
  4. Study completion28 Apr 2022

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04305197
Sponsor's protocol ID
ICP-CL-00109
Status last verified
Nov 2022
First submitted
10 Mar 2020
Last updated
30 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li R, Li X, Zhu X, Liu S, Zhang X, Xie C, Fu Z, Huang A, Sun L, Liu D, Zhao J, Wu L, Li Z. Orelabrutinib for systemic lupus erythematosus: A randomised, double-blind, placebo-controlled study. J Autoimmun. 2026 Jun;161:103578. doi: 10.1016/j.jaut.2026.103578. Epub 2026 May 29.

    PubMed 42214214

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ICP-022 in people with Systemic Lupus Erythematosus, run by Beijing InnoCare Pharma Tech Co., Ltd. at 11 sites 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 5 inclusion and 6 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 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 28 Days after the last dose of study drug). The study lists 6 primary outcomes in all. 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 NCT04305197, which also lists 1 linked publication.

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 30 Nov 2022.

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