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Systemic Lupus ErythematosusPhase 2PENCILNCT06356740

Efficacy and Tolerance of Abacavir/Lamivudine Treatment in Patients With Systemic Lupus Erythematosus

A Phase 2 study testing Blood sample, Treatment :Abacavir 600 mg/lamivudine 300 mg and Lupus Impact Tracker questionnaire in people with Systemic Lupus Erythematosus, run by Hospices Civils de Lyon at 11 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Systemic lupus (SL) is a rare chronic autoimmune disease characterized by the production of autoantibodies directed against nuclear antigens, particularly native double-stranded deoxyribonucleic acid (DNA), and excessive production of antiviral cytokines: type I interferons, particularly interferon alpha (IFN-α). Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Blood sample, Treatment :Abacavir 600 mg/lamivudine 300 mg and Lupus Impact Tracker questionnaire
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
11 sitesFrance
Study dates
1 Sep 2024to 1 Jun 2029
Phase
Phase 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 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient ≥12 years old (weighing more than 25 kg) and ≤ 65 years old
  • Diagnosis of SL according to 2019 American College of rheumatology (ACR) / European Ligue against Rheumatism (EULAR) criteria (score >10)
  • Patient with SL in remission or with low clinical activity according to LLDAS disease criteria
  • For patients (including sexually active adolescents) of childbearing age, effective contraception (sexual abstinence, hormonal contraception, intrauterine device or hormone-releasing system, cap, diaphragm, sponge with spermicide, or condom) for the entire duration of treatment is required. Pregnancy tests will be performed according to the inclusion criteria.
  • Patient affiliated to a social security scheme
  • Free, informed and written consent signed by patient or parents/legal guardian

Who cannot join

  • Patients with HLA-B*5701 status (risk of allergy or hypersensitivity to Abacavir)
  • History of allergy or hypersensitivity to abacavir, lamivudine, or excipients (tablet core: microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica, talc; film coating: hypromellose, titanium dioxide (E171), macrogol, polysorbate 80).
  • Patients on anti-retroviral therapy
  • Patients with chronic HIV, HBV or HCV infection
  • Pregnant or breast-feeding woman
  • Patient treated with Lamivudine and/or Abacavir
Show all 12Show fewer
  • Patient treated with a cytidine analog
  • Patient on treatment containing Cladribine
  • Patient on treatment containing a trimethoprim/sulfamethoxazole combination
  • Patients with renal insufficiency (creatinine clearance < 50 ml/min)
  • Patients with moderate or severe hepatic impairment (prothrombin level <50%)
  • Patient participating in other interventional drug research

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alexandre BELOT contact

04 27 85 61 26 ext. +33

Alexandre.belot@chu-lyon.fr

Samira PLASSART contact

04 27 85 54 42 ext. +33

Samira.plassart@chu-lyon.fr

11 sites in 1 country

France11 sites

  • Groupe Hospitalier Pellegrin-CHU de Bordeaux

    Bordeaux, 33076

    Christophe RICHEZ, MD, PhD, 05 56 79 56 79 ext. +33, christophe.richez@chu-bordeaux.fr

    Christophe RICHEZ, MD, PhD

  • Hôpital Femme-Mère-Enfant (HCL)

    Bron, 69677

    Alexandre BELOT, MD, PhD, 04 27 85 61 26 ext. +33, Alexandre.belot@chu-lyon.fr

    Alexandre BELOT, MD, PhD

  • CHU de Clermont-Ferrand - Hôpital Gabriel Montpied

    Clermont-Ferrand, 63003

    Marc ANDRE, MD, PhD, 0473751440 ext. +33, mandre@chu-clermontferrand.fr

    Marc ANDRE, MD, PhD

  • CHU Nord de Grenoble - Albert Michallon

    Grenoble, 38043

    Laurence BOUILLET, MD, PhD, 04 76 76 76 40 ext. +33, lbouillet@chu-grenoble.fr

    Laurence BOUILLET, MD, PhD

  • Hôpital Claude Huriez

    Lille, 59037

    Éric HACHULLA, MD, PhD, 03 20 44 56 50 ext. +33, eric.hachulla@chru-lille.fr

    Éric HACHULLA, MD, PhD

  • Hôpital de la Croix-Rousse (HCL)

    Lyon, 69004

    Yvan JAMILLOUX, MD, PhD, 0426732636 ext. +33, yvan.jamilloux@chu-lyon.fr

    Yvan JAMILLOUX, MD, PhD

  • Hôpital Edouard Herriot (HCL)

    Lyon, 69437

    Thomas BARBA, MD, 0472119583 ext. +33, thomas.barba@chu-lyon.fr

    Thomas BARBA, MD

  • Hôpital Necker-Enfants malades

    Paris, 75015

    Brigitte BADER-MEUNIER, MD, 0144494332 ext. +33, brigitte.bader-meunier@aphp.fr

    Brigitte BADER-MEUNIER, MD

  • Hôpital Pitié-Salpêtrière

    Paris, 75651

    Zahir AMOURA, MD, PhD, 01 42 17 80 01 ext. +33, zahir.amoura@aphp.fr

    Zahir AMOURA, MD, PhD

  • Hôpital Lyon Sud (HCL)

    Pierre-Bénite, 69310

    Mael Richard, MD, 0478861352 ext. +33, mael.richard@chu-lyon.fr

    Mael Richard, MD

  • CHU de Saint-Etienne - Hôpital Nord

    Saint-Priest-en-Jarez, 42270

    Martin KILLIAN, MD, PhD, 04 77 82 91 79 ext. +33, martin.killian@chu-st-etienne.fr

    Martin KILLIAN, MD, PhD

Other trials in France

About this study

Official title: Randomized Pilot Trial to Evaluate the Efficacy and Tolerance of Abacavir/Lamivudine Treatment in Patients With Systemic Lupus Erythematosus (PENCIL)

Systemic lupus (SL) is a rare chronic autoimmune disease characterized by the production of autoantibodies directed against nuclear antigens, particularly native double-stranded deoxyribonucleic acid (DNA), and excessive production of antiviral cytokines: type I interferons, particularly interferon alpha (IFN-α). IFN-α production results from the excessive detection of nucleic acids (DNA or Ribonucleic Acid (RNA)) by endosomal or intracytoplasmic receptors that are capable of inducing interferon production. The precise mechanisms of cytoplasmic sensor activation remain unknown; however, recent work in the field of interferonopathies suggests a role for human endogenous retroviruses (HERVs). HERVs are remnants of ancient infections caused by exogenous retroviruses integrated into the genome during evolution and represent 8% of the human genome.Several studies have suggested a role for HERVs in the development and maintenance of an excessive immune response in lupus patients and other autoimmune diseases by affecting the type I interferons (I IFN) signalling pathway.

To date, none of the approved immunosuppressive drugs for Systemic Lupus Erythematosus (SLE) have been shown to be effective in the background treatment of SL or in preventing relapse. Consequently, there is an urgent need to identify new molecules and therapeutic avenues for disease-modifying therapies.

Read more

In this study, an innovative therapeutic strategy using a combination of nucleoside reverse transcriptase inhibitors (NRTIs), abacavir/lamivudine, is proposed to treat SLE. Thus, we propose a pilot Phase II, randomized, open-label study using NRTIs in patients with SL in remission or with low clinical activity, and evaluating a biological endpoint (IFN signature), which is a direct proxy for the drug's expected effect.

The main objective is to compare the addition of Abacavir/Lamivudine (Add-on) to standard care for 6 months, on the value of the interferon (IFN) transcriptomic signature of patients with systemic lupus with low activity as defined by the Lupus Low Disease Activity State (LLDAS).

Being tested
Blood sample, Treatment :Abacavir 600 mg/lamivudine 300 mg, Lupus Impact Tracker questionnaire
Keywords
Systemic lupus, Systemic Lupus Erythematosus, abacavir, lamivudine, nucleoside reverse transcriptase inhibitors
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.

  • Blood sampleBiological

    blood test to assess :

    • human leukocyte antigen (HLA)-B*5701 status to identify risk of allergy or hypersensitivity to abacavir (the study treatment)
    • IFN-signature ans IFN-alpha dosage
    • human immunodeficiency virus (HIV), hepatitis B virus (HBV) and Hepatitis C virus (HCV) serologies
    • Human chorionic gonadotropin (βHCG)
    • HERVs dosage A biological collection will also be created. The total volume of blood collected specifically for the research for the entire duration of the study is 62.5 millilitre (mL) maximum.

  • Treatment :Abacavir 600 mg/lamivudine 300 mgDrug

    Patients randomised to the experimental arm will be required to take 1 tablet (600 mg lamivudine and 300 mg abacavir) once daily for 6 months in addition to their usual treatment.

  • Lupus Impact Tracker questionnaireOther

    Patients will be asked to complete the Lupus Impact Tracker questionnaire at visit V1 (randomisation visit), visit 3 (at 6 months of treatment) and visit 4 (12 months after visit 1).

Study groups in NCT06356740
Study groupRoleWhat they receive
Abacavir 600 mg/lamivudine 300 mgExperimentalPatients randomized to this group will take 1 tablet (600 mg lamivudine and 300 mg abacavir) once daily for 6 months in addition to their usual treatment.
Receives: Biological: Blood sample; Drug: Treatment :Abacavir 600 mg/lamivudine 300 mg; Other: Lupus Impact Tracker questionnaire
Control group (standard of care)Active comparatorPatients randomized to this group will continue their usual treatment for lupus systemic.
Receives: Biological: Blood sample; Other: Lupus Impact Tracker questionnaire

What is being measured

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

  1. Absolute variation in interferon signature (IFN)

    Absolute change in interferon (IFN) signature will be assessed between the start of treatment (M0) and after 6 months of treatment (M6) in the total population (then in the pediatric population, then in the adult population)..

    Measured: At M6 (after 6 months of treatment)

Secondary outcomes (12)

  1. percentage of patients maintaining LLDAS criteria

    The percentage of patients maintaining LLDAS criteria will be assessed at M6 and M12 in the 2 arms.

    Measured: until 12 months after randomisation

  2. number of relapses

    number of relapses and time to relapse between M0 and M12 (collected continuously) will be assessed

    Measured: until 12 months after randomisation

  3. anti-native double-stranded DNA quantification

    Evaluation of the effect of treatment on lupus biomarkers by quantifying anti-native double-stranded DNA

    Measured: until 12 months after randomisation

  4. anti-extractable nuclear antigens (anti-ENA) quantification

    Evaluation of the effect of treatment on lupus biomarkers by quantifying anti-ENA

    Measured: until 12 months after randomisation

  5. interferon-α production quantification

    Evaluation of the effect of treatment on lupus biomarkers by interferon-α production

    Measured: until 12 months after randomisation

  6. Number of successful patients

    The number of patients in each arm achieving success will be assessed. Success is defined as a ≥50% reduction in IFN signature between M0 and M6.

    Measured: until 6 months after randomisation

  7. Cumulative dose of intravenous (IV) corticosteroids

    The impact of treatment on corticosteroid intake in the "Intervention" arm and the "No intervention" arm at M control arm will be assessed by observing the cumulative dose of intravenous (IV) and oral corticosteroids.

    Measured: until 12 months after randomisation

  8. Lupus Impact Tracker questionnaire score

    Quality of life will be assessed by comparing Lupus Impact Tracker™ questionnaire scores at M6 and M12 in the Intervention arm and control arm.

    The lupus impact tracker (LIT) is a 10-item patient reported outcome tool to measure the impact of systemic lupus erythematosus or its treatment on patients' daily lives. Each answer is marked from 0 to 4 points. The lower the Lupus Impact score, the less impact lupus is having on the life of patient.

    Measured: until 12 months after randomisation

  9. number of missed treatment

    Adherence to treatment will be assessed by recording the number of doses missed and the reasons for missed doses.

    Measured: until 6 months after randomisation

  10. number of adverse event (AE)

    To assess the safety and tolerability of the drug, the number of AE will be compared between the two randomisation arms.

    Measured: until 12 months after randomisation

  11. number of serious adverse event (SAE)

    To assess the safety and tolerability of the drug, the number of SAE will be compared between the two randomisation arms.

    Measured: until 12 months after randomisation

  12. HERVs transcription quantification

    The difference in HERVs copy number in the 2 arms will be assessed. A comparison between groups will be performed.

    Measured: until 12 months after randomisation

Timeline

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

  1. First posted10 Apr 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion1 Nov 2028 (estimated)
  4. Study completion1 Jun 2029 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label randomized, controlled study with 2 parallel arms (Add-on treatment versus standard of care treatment)
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06356740
Sponsor's protocol ID
69HCL22_0878
Other IDs
2023-508611-22-00, 2023
Acronym
PENCIL
Status last verified
Apr 2024
First submitted
4 Apr 2024
Last updated
10 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Blood sample, Treatment :Abacavir 600 mg/lamivudine 300 mg and Lupus Impact Tracker questionnaire in people with Systemic Lupus Erythematosus, run by Hospices Civils de Lyon at 11 sites in France.

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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 10 Apr 2024. 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 France. 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?

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?

Contact Alexandre BELOT (04 27 85 61 26 ext. +33, Alexandre.belot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute variation in interferon signature (IFN) (time frame: At M6 (after 6 months of treatment)). 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 NCT06356740.

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 10 Apr 2024.

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