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Lupus Erythematosus, SystemicPhase 1/2NCT06015230

Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE

A Phase 1/2 study testing low dose GR1603 in phase Ⅰb, high dose GR1603 in phaseⅠb and low dose GR1603 in phase Ⅱ in people with Lupus Erythematosus, Systemic, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A Study to Investigate the Tolerability, Safety,Pharmacokinetics and efficacy of GR1603 in subjects with Systemic Lupus Erythematosus ； GR1603 injection is a monoclonal antibody targeting IFNAR1, which can block IFNAR binding to type I interferons such as IFNα and be used to treat systemic lupus erythematosus. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
low dose GR1603 in phase Ⅰb, high dose GR1603 in phaseⅠb and low dose GR1603 in phase Ⅱ
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
136 participants
Where
1 siteChina
Study dates
8 Mar 2022to 4 Oct 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of SLE according to the ACR 1997 ≥24 weeks
  • Active moderate to severe SLE
  • At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.

Who cannot join

  • Active severe or unstable neuropsychiatric SLE
  • Clinically significant laboratory test
  • Clinically significant active infection

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking union Medical Hosipital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Phase Ⅰb/Ⅱ, Randomized, Double-blind, Placebo-controlled Study to Investigate the Tolerability, Safety,Pharmacokinetics and Efficacy of an Intravenous Treatment Regimen of GR1603 in Subjects with Systemic Lupus Erythematosus

A Study to Investigate the Tolerability, Safety,Pharmacokinetics and efficacy of GR1603 in subjects with Systemic Lupus Erythematosus ； GR1603 injection is a monoclonal antibody targeting IFNAR1, which can block IFNAR binding to type I interferons such as IFNα and be used to treat systemic lupus erythematosus.

Read the detailed description

This is a Phase Ib/Ⅱ,double blind, multiple-dose study to evaluate the pharmacokinetics (PK), safety，tolerability and efficacy of intravenously administered GR1603 in participants with active SLE despite receiving standard of care .

Phase Ib is a multi-dose escalation phase in which 16 subjects are scheduled to enroll.

A total of 120 subjects were randomly assigned to GR1603 injection low dose group, high dose group or placebo group in phase Ⅱ.

Being tested
low dose GR1603 in phase Ⅰb, high dose GR1603 in phaseⅠb, low dose GR1603 in phase Ⅱ, high dose GR1603 in phase Ⅱ, Placebo in phase Ⅱ
Keywords
IFNR, Autoimmune Diseases, SLE
Medical subject headings
Lupus Erythematosus, Systemic, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low dose GR1603 in phase ⅠbBiological

    6 subjects in GR1603 low dose，2 subjects in placebo

  • high dose GR1603 in phaseⅠbBiological

    6 subjects in GR1603 high dose，2 subjects in placebo

  • low dose GR1603 in phase ⅡBiological

    low dose GR1603 monthly

  • high dose GR1603 in phase ⅡBiological

    high dose GR1603 monthly

  • Placebo in phase ⅡBiological

    Placebo

Study groups in NCT06015230
Study groupRoleWhat they receive
Treatment group 1-ⅠbExperimental6 subjects in GR1603 low dose，2 subjects in placebo
Receives: Biological: low dose GR1603 in phase Ⅰb
Treatment group 2-ⅠbExperimental6 subjects in GR1603 high dose，2 subjects in placebo
Receives: Biological: high dose GR1603 in phaseⅠb
treatment group 3-ⅡExperimentallow dose GR1603 monthly
Receives: Biological: low dose GR1603 in phase Ⅱ
treatment group 4-ⅡExperimentalhigh dose GR1603 monthly
Receives: Biological: high dose GR1603 in phase Ⅱ
treatment group 5-ⅡPlacebo comparatorplacebo
Receives: Biological: Placebo in phase Ⅱ

What is being measured

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

  1. Adverse events(phase Ib)

    to characterise the safety and tolerability of GR1603,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination

    Measured: up to week 16

  2. Number of participants who achieved BICLA response (phase Ⅱ)

    BICLA respnse:reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B

    Measured: week 24

Secondary outcomes (12)

  1. Cmax(phaseⅠb）

    Pharmacokinetic indices

    Measured: up to week 16

  2. AUC0-t(phaseⅠb）

    Pharmacokinetic indices

    Measured: up to week 16

  3. AUC0-∞(phaseⅠb）

    Pharmacokinetic indices

    Measured: up to week 16

  4. AUCss(phaseⅠb）

    Pharmacokinetic indices

    Measured: up to week 16

  5. Tmax(phaseⅠb）

    Pharmacokinetic indices

    Measured: up to week 16

  6. t1/2z(phaseⅠb）

    Pharmacokinetic indices

    Measured: up to week 16

  7. Vz(phaseⅠb）

    Pharmacokinetic indices

    Measured: up to week 16

  8. CLz(phaseⅠb）

    Pharmacokinetic indices

    Measured: up to week 16

  9. Number of participants who achieved SRI (4)(phase Ⅱ)

    An SRI (4) responder defined as a participant who had a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than or equal to 4 points;

    Measured: up to week 28

  10. Number of participants who achieved BICLA response(phase Ⅱ)

    BICLA respnse:reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B

    Measured: up to week 28

  11. Number of participants with a ≥50% reduction in CLASI activity score (phase Ⅱ)

    CLASI:Cutaneous Lupus Erythematosus Disease Area and Severity Index

    Measured: up to week 28

  12. Flare rate(phase Ⅱ）

    A flare was defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG-2004 B items compared to the previous visit

    Measured: up to week 28

Timeline

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

  1. First posted29 Aug 2023
  2. Study start8 Mar 2022
  3. Primary completion10 Jun 2028 (estimated)
  4. Study completion4 Oct 2028 (estimated)

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06015230
Sponsor's protocol ID
GR1603-002
Status last verified
Sep 2024
First submitted
1 Jun 2023
Last updated
25 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing low dose GR1603 in phase Ⅰb, high dose GR1603 in phaseⅠb and low dose GR1603 in phase Ⅱ in people with Lupus Erythematosus, Systemic, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. 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 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2024. 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Adverse events(phase Ib) (time frame: up to week 16). The study lists 2 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 NCT06015230.

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 25 Sep 2024.

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