Adalimumab Treatment for Patients with Hidradenitis Suppurativa at high risk of Progressing to Severe Disease: An Unblinded Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary outcome: Development of severe HS over a two-year period Endpoint: Percentage of subjects with non-severe HS at baseline who progress to severe HS at any time from baseline (Week 0) until visit 10 (Week 104) in the Adalimumab arm compared with the SOC arm. For this purpose, severe HS will be defined as having either: 1. Hurley stage 3: Multiple interconnected sinus tracts and nodules/abscesses throughout the affected area. or 2. an IHS4 score ≥11 points
研究概览
简要总结
The primary objective is to answer the following research question: In adults with non-severe hidradenitis suppurativa (HS) but a high risk of progression to severe disease, does treatment with adalimumab, compared with standard of care (SOC [doxycycline]), reduce the proportion of patients who progress to severe disease over a 104-week period?
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Must be able to understand written and spoken Danish • Patient must previously have had their HS diagnosis verified by a dermatologist, or have it verified by the Investigator at the screening visit/baseline • High risk of progressing to severe HS according to the risk algorithm • Active HS lesion present at screening and baseline • IHS4 score < 11 and Hurley stage < 3 • Blood test within institutional reference ranges: o Hemoglobin (Hb): 7,3-9,5 mmol/L (female), 8,3-10,5 mmol/L (male) o Leukocytes with differential count (Leu+ Diff): 3,5-8,8 x 10^9 /L o C-reactive protein (CRP): < 10 mg/L o Thrombocytes (Trc): 145-390 x 10^9 /L o Alanine transaminase (ALAT): 10-45 U/L (female), 10-70 (male) o Aspartate transaminase (ASAT): 15-35 U/L (female), 15-45 (male) o Alkaline phosphatase (BP): 35-105 U/L o Bilirubin (BF): 3-18 µmol/L (female), 3-25 µmol/L (male) o Creatinine: 50-90 µmol/L (female), 60-105 µmol/L (male) o Sodium (Na): 137 – 144 mmol/L o Potassium (K): 3,5 – 4,4 mmol/L o Hepatitis-B serology: HBsAg and HBV DNA negative o Hepatitis-C serology: Anti-HCV and HCV RNA negative o Varicella zoster virus (VZV): IgG positive o Antinuclear antibodies (ANA): Negative <0,7 o Human Immunodeficiency virus (HIV): Negative test for HIV-1 and HIV-2 antibodies o Tuberculosis (TB): Negative IGRA test • No prior biological treatment for HS • HS-patient at Gentofte Hospital • Signed informed consent before inclusion • Patients must be cognitively intact enough to independently answer questions in the questionnaires • Women of childbearing potential must be willing to use a highly effective form of birth control throughout the trial and for at least 12 weeks after last administration of the study drug. • > 18 years old
排除标准
- •Sensitivity/allergy towards either SOC or Adalimumab ingredients • Other contraindication according to Adalimumab’s EU Summary of product characteristics (SmPC) dossier including: o Ongoing acute or chronic infection o Moderate to severe congestive heart failure (NYHA class III or IV) o Treatment with a live vaccine within 3 months prior to study drug administration o History of demyelinating neurological disease • Concurrent immune suppression with another biological agent , e.g. Anakinra, Ixekizumab, Secukinumab or Ustekinumab • Prior systemic HS treatment still in effect (a five-half-live washout period must have transpired before baseline inclusion) • Concurrent topical treatment for HS • Pathological chest x-ray with signs of granulomatous disease, malignancy, chronic lung disease e.g. moderate to severe pulmonary fibrosis, emphysema, cardiovascular abnormalities, pleural effusions • Positive medical history of cancer excluding non-melanoma skin cancer • Blood tests outside of acceptable limits (Hb, Leu+ Diff, CRP, Trc, ALAT, ASAT, BP, BF, Creatinine, Na, K, Hepatitis-B, Hepatitis-C, VZV, ANA, HIV) • Positive test for tuberculosis • Low risk of progressing to severe HS according to the risk algorithm • Hurley Stage III • IHS4 score ≥11 points • Prior biological treatment for HS, e.g. Adalimumab, Anakinra, Ixekizumab, Secukinumab or Ustekinumab • Pregnancy • Breastfeeding • Wish or plan to become pregnant during the two-year study period • Planned surgical treatment of HS in the treated areas • Comorbidities who according to the Investigator makes the participants unsuited for participation in a clinical trial • Patient unable to provide informed consent
结局指标
主要结局
The primary outcome: Development of severe HS over a two-year period Endpoint: Percentage of subjects with non-severe HS at baseline who progress to severe HS at any time from baseline (Week 0) until visit 10 (Week 104) in the Adalimumab arm compared with the SOC arm. For this purpose, severe HS will be defined as having either: 1. Hurley stage 3: Multiple interconnected sinus tracts and nodules/abscesses throughout the affected area. or 2. an IHS4 score ≥11 points
The primary outcome: Development of severe HS over a two-year period Endpoint: Percentage of subjects with non-severe HS at baseline who progress to severe HS at any time from baseline (Week 0) until visit 10 (Week 104) in the Adalimumab arm compared with the SOC arm. For this purpose, severe HS will be defined as having either: 1. Hurley stage 3: Multiple interconnected sinus tracts and nodules/abscesses throughout the affected area. or 2. an IHS4 score ≥11 points
次要结局
未报告次要终点
研究者
Rune Kjærsgaard Andersen
Scientific
Gentofte Hospital