A Phase 2 interventional study of nicotinamide in Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus Rash, sponsored by Second Xiangya Hospital of Central South University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by Second Xiangya Hospital of Central South University · Phase 2, Interventional, and Treatment
This clinical study will test the efficacy and safety of nicotinamide for lupus-associated skin lesions refractory to the treatment of hydroxychloroquine plus low-dose corticosteroids in patients with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE).
Backgrounds: Lupus erythematosus (LE) is an autoimmune disease affecting various organs. Lupus-associated skin lesions are the dominant clinical manifestations of cutaneous lupus erythematosus (CLE) and also occur in 70%\~80% of patients with systemic lupus erythematosus (SLE), and usually involve the sunlight-exposure sites such as the face, neck and hands, which affects the personal appearance dramatically and causes substantial psychological impact to the patients.
While antimalarials such as hydroxychloroquine (HCQ) have been widely used as a first-line treatment for lupus-associated skin lesions, 30% of patients with lupus do not respond to this medication. Other available therapies such as corticosteroids and thalidomide can also be applied, however, their toxic side effects limit the clinical use. Recent studies by the investigators have shown that nicotinamide, a water-soluble vitamin whose side effects are considered as minimal, can protect MRL/lpr mice (a lupus-like mouse model) from skin lesions and autoantibody production. Thus it is hypothesized that nicotinamide treatment could be a novel therapy for lupus-associated skin lesions in patients with LE.
Design of Study: This is a single center, uncontrolled, open-label study to assess the efficacy and safety of nicotinamide for lupus-associated skin lesions refractory to the treatment of HCQ plus low-dose corticosteroids in patients with CLE or SLE.
Methods: For CLE or SLE patients with lupus-associated skin lesions scoring >=4 on the Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI) that have been refractory to the treatment of HCQ plus low-dose corticosteroids (\<=0.5 mg/kg/d) during the past two months, oral nicotinamide (500 mg twice daily) will be given consecutively for 3 months while the current regimen including HCQ and corticosteroids be maintained without change. The end points include clinical response and immunological changes, as well as safety.
Exclusion Criteria:
Patients will receive 10 nicotinamide tablets orally twice daily (nicotinamide 500 mg, p.o., Bid) for a period of 3 months. Each tablet contains 50 mg of nicotinamide.
Drug: nicotinamide
Drug: nicotinamide; Pharmaceutical form: tablet; Route of administration: oral
Also known as: Niacinamide
A change in Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI) activity score
The higher the RCLASI score, the worse of the lupus-associated skin lesion is.
Time frame: from baseline (at visit 0) to 3 months treatment (at visit 3)
A change in RCLASI activity score
The higher the RCLASI score, the worse of the lupus-associated skin lesion is.
Time frame: from baseline (at visit 0) to 1, 2, 4, and 6 months treatment (at visit 1, 2, 4, and 5), respectively
Response Rate and Remarkable Response Rate at 1, 2, 3, 4, and 6 months, respectively
Response is defined as a ≥ 4-point reduction or a ≥20% reduction in RCALSI activity score. Remarkable Response is defined as a ≥50% reduction in RCALSI activity score.
Time frame: 1 month, 2 months, 3 months, 4 months, and 6 months
Number of Relapses
Relapse means that if the patient's RCLASI activity score has a ≥ 4-point reduction or a ≥20% reduction than at baseline during the 3-month treatment, and then the RCLASI activity score increase to be no lower than at baseline after stopping using nicotinamide in the following 3 months.
Time frame: 4 months, 6 months
A change in Dermatology Life Quality Index (DLQI) score
DLQI reflect the quality of life related to skin manifestations.
Time frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively
A change in Physician's Global Assessment (PGA) score
Time frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively
A change in the percentage of different T helper cell (Th) subsets among CD4+ T lymphocytes
At each time point, the percentage of Th1, Th2, Th17, regulatory T cell (Treg), and follicular helper T cell (Tfh) subsets among CD4+ T lymphocytes in peripheral venous blood of the patient will be measured by flow cytometry. 5 ml of peripheral venous blood will be collected from the patient at each time point, of which 4.5 ml will be used in this flow cytometry assay.
Time frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively
A change in the serum level of cytokines interferon (IFN)γ, interleukin (IL)-4, IL-17A, transforming growth factor (TGF)-β, IL-10, IL-21, and IL-6
At each time point, the serum level of cytokines IFNγ, IL-4, IL-17A, TGF-β, IL-10, IL-21, and IL-6 in the patient's venous blood will be measured using enzyme linked immunosorbent assay (ELISA) or Bio-Plex methods. 5 ml of peripheral venous blood will be collected from the patient at each time point, of which 0.5 ml will be used in this ELISA or Bio-Plex assay.
Time frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively
A change in serum levels of complement 3 (C3), C4, and C1q
This is for evaluation of the potential effects of nicotinamide on serum levels of complements that are associated with lupus activity
Time frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively
A change in the results of urine sediment test
This is for evaluation of the potential effects of nicotinamide on renal damage.
Time frame: 1 month, 2 months, 3 months, 4 months, and 6 months
Dose reduction of concomitant corticosteroids
Time frame: from baseline (at visit 0) to 3 months, 4 months, and 6 months (at visit 3, 4, and 5), respectively
A change in SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus National Assessment version of the systemic lupus erythematosus disease activity index)
This outcome is only evaluated for patients with SLE.
Time frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively
A change in British Isles Lupus Assessment Group 2004 Index (BILAG-2004)
This outcome is only evaluated for patients with SLE.
Time frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively
Incidence of side effects
Possible side effects of nicotinamide include flushing and itching of the skin, cardiac arrhythmia, dizziness, nausea, epigastric discomfort, loss of appetite, elevated blood glucose, and elevated blood uric acid. The major side effects of HCQ that need to be monitored include retina toxicity.
Time frame: 3 months
Incidence of side effects
Possible side effects of nicotinamide include flushing and itching of the skin, cardiac arrhythmia, dizziness, nausea, epigastric discomfort, loss of appetite, elevated blood glucose, and elevated blood uric acid. The major side effects of HCQ that need to be monitored include retina toxicity.
Time frame: 6 months
Plan to share: No
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Lupus Erythematosus, Systemic→
Second Xiangya Hospital of Central South University