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Relapsing PolychondritisPhase 2NCT04077736

Low-dose Recombinant Human IL-2 for the Treatment of Relapsing Polychondritis

A Phase 2 study testing Interleukin-2 in people with Relapsing Polychondritis, run by Peking University People's Hospital at 1 site 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

Relapsing polychondritis (RP) is a rare, systemic autoimmune disorder characterized by episodic inflammation of cartilaginous structures. Pro-inflammatory chemokines involved in the recruitment of monocytes and modulation of macrophage function, such as monocyte chemoattractant protein-1, macrophage inflammatory… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Relapsing Polychondritis
What is being tested?
Interleukin-2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
1 Nov 2019to 30 Oct 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female ≥18 and ≤70 years
  • Meet the revised Michet criteria
  • Patients had an inadequate response to standard treatment for ≥ 4 weeks. The background treatment included corticosteroids (≤0.5 mg/ kg), immunosuppressants ( methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil leflunomide, or cyclophosphamide)
  • Negative urine pregnancy test
  • Written informed consent form

Who cannot join

  • Any subject who meets any of the following criteria shall be excluded:
  • Use rituximab or other monoclonal antibodies within 1.6 months.
  • 1 months after treatment with high dose glucocorticoid (> 1 mg/kg/d).
  • Serious complications: heart failure (≥ New York Heart Association（NYHA） III grade), renal insufficiency (creatinine clearance rate ≤ 30 ml/min), liver function insufficiency (serum alanine transaminase or glutamic-pyruvic transaminaseT > 3 times normal upper limit, or total bilirubin > normal upper limit)
  • Other serious, progressive or uncontrollable hematological, gastrointestinal, endocrine, lung, heart, nerve, or brain diseases (including demyelination diseases, such as multiple sclerosis).
  • Known allergies, hyperresponsiveness or IL-2 or its excipients are intolerant.
Show all 14Show fewer
  • Severe infections (including, but not limited to, hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus, tuberculosis infection), hospitalization for infection, or intravenous antibiotics 2 months before the first dose of treatment.
  • Chest imaging showed abnormalities in malignant tumors or current active infections (including tuberculosis) within 3 months before the first use of the study.
  • Infected with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, consult a doctor with expertise in the treatment of HIV or hepatitis C virus infection.
  • There has been any known malignant tumor or history of malignant tumor in the past 5 years (with the exception of non-melanoma skin cancer, non-melanoma skin cancer with no sign of recurrence or surgically cured cervical tumor within 3 months of use of the first study preparation).
  • There are uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past three years, which may hinder the successful completion of the study.
  • Within 3 months before the first injection of the research agent, during the study period or within 4 months after the last injection of the research agent, any live virus or bacterial vaccine is received or expected to be received. Bacillus Calmette-Guerin was vaccinated within 12 months after screening.
  • Pregnant and lactating women (WCBP) are reluctant to use medically approved contraceptives during and 12 months after treatment.
  • Men whose partners have fertility potential but do not want to use appropriate medically approved contraceptives during and within 12 months of treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Rheumatology and Immunology, Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

Other trials in China

About this study

Official title: A Pilot Study of Low Dose IL-2 in the Treatment of Relapsing Polychondritis

Relapsing polychondritis (RP) is a rare, systemic autoimmune disorder characterized by episodic inflammation of cartilaginous structures. Pro-inflammatory chemokines involved in the recruitment of monocytes and modulation of macrophage function, such as monocyte chemoattractant protein-1, macrophage inflammatory protein 1β, and interleukin (IL)-8, are significantly elevated in active RP compared with controls.The activation of monocytes and macrophages may play an important role in the pathophysiology of RP. The levels of serum Th1 cytokines (interferon, IL-2 (IL-2) and IL-12 (IL-12) were significantly correlated with disease status，which suggested that RP may be a Th1-mediated disease process. IL-2 is a kind of lymphocyte growth factor. At lower doses, regulatory T cells exhibit dominant amplification because of their more sensitivity to IL-2. Regulatory T cells can inhibit the growth of effector T cells and then play an immunosuppressive role. The investigators hypothesized that low-dose IL-2 could be a novel therapy in active RP patients. This clinical study will explore the efficacy and immunological evaluation of low dose IL-2 in the treatment of RP.

Read the detailed description

Ten patients with active RP at 18 to 70 years of age were enrolled. Without changing the original treatment plan, IL-2 1 million units was administered subcutaneously five days every week for 4 weeks and then once a week for 8 weeks. The clinical symptoms, disease score scale, laboratory parameters, immune cell subsets and cytokines should be monitored during the treatment.

Being tested
Interleukin-2
Keywords
Relapsing polychondritis，IL-2
Medical subject headings
Polychondritis, Relapsing

What participants receive

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

  • Interleukin-2Drug

    Also called Recombinant Human Interleukin-2

    low dose interleukin-2 injected subcutaneously, at a dose of 1 million IU five days per week for 4 weeks (day1-5, 8-12, 15-19, 22-26) and then once a week for 8 weeks (day33, 40, 47, 54, 61, 68, 75, 82).

Study groups in NCT04077736
Study groupRoleWhat they receive
Interleukin-2Experimentallow dose interleukin-2 injected subcutaneously, at a dose of 1 million IU five days per week for 4 weeks (day1-5, 8-12, 15-19, 22-26) and then once a week for 8 weeks (day33, 40, 47, 54, 61, 68, 75, 82).
Receives: Drug: Interleukin-2

What is being measured

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

  1. Foxp3+Treg cells: change in percentage of total lymphocytes

    Treg refers to regulatory T cells

    Measured: week 12

Secondary outcomes (2)

  1. Relapsing Polychondritis Disease Activity Index

    Relapsing Polychondritis Disease Activity Index

    Measured: week 12

  2. safety assessment

    Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor,drug-induced liver and kidney damage.

    Measured: week 12

Timeline

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

  1. First posted4 Sep 2019
  2. Study start1 Nov 2019
  3. Primary completion10 Oct 2023
  4. Study completion30 Oct 2023

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04077736
Sponsor's protocol ID
2019PHB089-02
Status last verified
Feb 2024
First submitted
1 Sep 2019
Last updated
26 Feb 2024
Results posted
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 2 study testing Interleukin-2 in people with Relapsing Polychondritis, run by Peking University People's Hospital 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 5 inclusion and 14 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 26 Feb 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. 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?

Foxp3+Treg cells: change in percentage of total lymphocytes (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 NCT04077736.

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 26 Feb 2024.

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