A study to find out if Nemolizumab works in participants with systemic sclerosis and how safe it is

Switzerland, United States (ICTRP)

ID di studio ICTRP
NCT07047690 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
A 52-week, Multicenter, Randomized, Double-blind, Placebocontrolled, Dose-ranging Study of Nemolizumab in Adult Patients with Systemic Sclerosis (BASEC)

Titolo accademico
A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Nemolizumab in Adult Patients With Systemic Sclerosis (ICTRP)

Titolo pubblico
A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis (ICTRP)

Malattie studiate

Systemic Sclerosis

(ICTRP)

Intervento studiato

Drug: NemolizumabDrug: Placebo

(ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).

(ICTRP)

Criteri di inclusione/esclusione

Inclusion Criteria:

1. Participant must be 18 years of age or older, at the time of signing the Informed
Consent Form.

2. Classification of systemic sclerosis (SSc) as defined by the 2013 American College
of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria.

3. Modified Rodnan Skin Score.

1. Diffuse cutaneous systemic sclerosis (DcSSc) participants and modified Rodnan
Skin Score (mRSS) of greater than equal to (>=)12 and less than (<)30 at both
screening and baseline

2. Limited cutaneous systemic sclerosis (LcSSc) participants with mRSS >=8 at both
screening and baseline. LcSSc participants with positive anti-centromere at
screening are excluded.

4. Disease duration in DcSSc participants <= 5 years from screening and LcSSc
participants <=2 years from screening is defined as the time from the first
non-Raynaud's phenomenon manifestation of SSc.

5. Participants are permitted to receive the following background therapies stable for
at least 3 months prior to baseline, including any combination of the following:

1. Nintedanib (<150mg twice daily) and/or

2. One of the following:

1. Methotrexate (MTX) (<25mg weekly) or

2. Mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or mycophenolic
acid (MPA) (<3000mg daily MMF, <2160mg daily for MPS or MPA) NOTE: MTX
should not be used in combination with MMF/MPS/MPA

6. Participants with evidence for active or progressive disease.

7. Men (whose female partner can become pregnant) and women of childbearing potential
will be required to use effective means of contraception or commit to true
abstinence, when this is in line with preferred and usual lifestyle of the
participant, during the study and for at least 12 weeks after receiving the last
study treatment.

8. Female participants of non-childbearing potential

9. Signed informed consent

Exclusion Criteria:

1. Anti-centromere antibody positive at screening for participants with LcSSc.

2. Anti-RNA polymerase 3 antibody positive for participants with a disease duration
>18months.

3. Creatinine clearance <30 milli liter per minute [ml/min] (calculated by
Cockcroft-Gault formula).

4. Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core
antibody [HbcAb], hepatitis C [HCV] antibody with positive confirmatory test for
hepatitis C virus [HCV] antibody with positive HCV RNA, or human immunodeficiency
virus [HIV] antibody).

5. FVC <50% of predicted normal value, and DLCO <40% of predicted normal value
(corrected for Hb) at screening and baseline.

6. Known diagnosis of clinically significant respiratory disorders other than ILD,
including severe chronic obstructive pulmonary disease, severe asthma, recent
(within 3 months) severe respiratory infections or history of recurrent respiratory
infections, smoking, and any other respiratory condition that, in the opinion of the
investigator, could interfere with the study or pose a risk to the participant.

7. Currently listed and/or anticipated to be listed for lung transplantation within the
next 12 months.

8. Cardiovascular disease with clinically significant arrhythmia requiring therapy,
congestive heart failure (New York Heart Association Class III-IV functional
capacity), unstable angina, uncontrolled hypertension, Cor pulmonale, or symptomatic
pericardial effusion.

9. History of myocardial infarction in the last 6 months prior to screening.

10. Pulmonary hypertension WHO Functional Class III or higher (as defined by WHO 2009)
requiring treatment.

11. Clinical signs of severe malabsorption in the opinion of the investigator or needing
parenteral nutrition.

12. History of scleroderma renal crisis (SRC) 6 months prior to screening.

13. Participants with underlying chronic liver disease (Child Pugh A, B, C hepatic
impairment).

14. Body weight of <30.0 kilogram (Kg) at screening or BL

15. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed,
or unwilling to use appropriate contraception measures during the study period

16. Previous treatment with nemolizumab

17. Participants with the primary diagnosis of a rheumatic autoimmune disease other than
SSc, including but not limited to rheumatoid arthritis, systemic lupus
erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren's
syndrome, anti-synthetase syndrome, or mixed CTD, as determined by the investigator
with consultation of the medical monitors

18. Systemic sclerosis-like illness including but not limited to localized scleroderma
(morphea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro
mucinous conditions (scleredema, scleromyxedema), scleroderma-like conditions that
are associated with environmental chemical and drug exposure (e.g., toxic rapeseed
oil, vinyl chloride, bleomycin, gadolinium-based contrast agents [nephrogenic
systemic fibrosis], or due to metabolic disease)

19. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product
(plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the study
treatment excipient

20. Known active bacterial, viral, fungal, or any major episode of infection requiring
hospitalization or treatment with IV antibiotics or antivirals within 4 weeks prior
to screening, or oral antibiotics within 2 weeks prior to screening. Participants
may be rescreened once the infection has resolved.

21. History of a primary immunodeficiency

22. History of Bone Morrow Transplantation. Chimeric Antigen Receptor (CAR)-T Cell
Therapy or any other genetically engineering cells

23. History of lymphoproliferative disease or history of malignancy of any organ system
within the last 5 years, except for (1) basal cell carcinoma, squamous cell
carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have
been treated and have no evidence of recurrence in the last 12 weeks before the BL
visit, or (2) actinic keratoses that have been treated

24. History of alcohol or substance abuse dependence or any condition that, in the
investigator's opinion makes the participant unreliable to following instructions
and complete the study

25. In the opinion of the investigator, the participant has any medical condition,
including clinically significant pulmonary abnormalities, or psychological
condition,or clinically significant laboratory abnormalities that could pose undue
risk to the participant, prevent study completion or adversely affect the validity
or interpretability of the study measurements or interfere with the study
assessments, or impede the participant's ability to complete the study.

26. Participant has not adhered to the restrictions in select treatments prior to
screening or is not expected to be compliant with restrictions during the study

(ICTRP)

non disponibile

Endpoint primari e secondari

Change From Baseline (BL) in Modified Rodnan Skin Score (mRSS) at Week 52

(ICTRP)

Change From Baseline in Forced Vital Capacity (FVC) at Week 52;Proportion of Responders to the Treatment Based on the Revised Composite Response Index in Systemic Sclerosis (rCRISS) at Week 52;Change From Baseline in mRSS at Weeks 8, 12, 24, 28, 36, 44, 52;Percent change from Baseline in mRSS at Week 52;Change from Baseline in Percent Predicted FVC (ppFVC) at Week 52;Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52;Percent Change From Baseline in Patient's Global Assessment (PGA) Score at Week 52;Percent Change From Baseline in Clinician's Global Assessment (CGA) Score at Week 52;Incidence and Severity of TEAEs, Treatment-Emergent SAEs, Treatment-Emergent AEs of Special Interest (AESIs), Significant SSc-Related TEAEs, TEAEs Leading to Investigational Product Discontinuation and Study Discontinuation.;Incidence of Abnormal Vital Signs;Incidence of Abnormal Laboratory Parameters;Incidence of Abnormal Electrocardiogram (ECG) Findings;Incidence of Abnormal Weight Change

(ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Galderma Research and Development, clinical.studies@galderma.com, 817-961-5000 (ICTRP)

ID secondari
SPR207796 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT07047690 (ICTRP)