Prurigo Nodularis
Conditions
Interventions
Test group 1:Rocatinlimab 300 mg
placebo group:placebo
Test group 2:Rocatinlimab 150 mg
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Subject or the subject’s legally authorized representative (if allowed, depending on the country concerned) has provided informed consent before initiation of any study-specific activities/procedures. 2.Age >=18 years (or >= legal age within the country if it is older than 18 years). 3.A clinical diagnosis of prurigo nodularis (as defined by core symptoms according to the United States expert panel consensus [Elmariah et al, 2021]), that has been present for at least 3 months before signing of informed consent. The prurigo nodularis defined core symptoms include pruritus for more than 6 weeks, evidence of chronic scratching, and presence of multiple pruriginous lesions and excoriated nodules. 4.Patient-reported average Worst-Itch NRS >=7 based on electronic daily diary assessment the last 7 days prior to day 1, at day 1 prerandomization. 5.Has >= 20 prurigo nodularis nodules in total with bilateral distribution on both legs, and/or both arms and/or trunk at initial screening and at day 1 prerandomization. 6.Prior to informed consent, history of inadequate response to TCS of medium or higher potency for prurigo nodularis (with or without TCI as appropriate) or for whom TCS is otherwise medically inadvisable (eg, because of important side effects or safety risks). - Inadequate response is defined as inability to achieve and/or maintain a low disease state (comparable to IGA CNPG-S score of <= 2) despite treatment with a daily regimen of medium-to-super potent TCS (+/- TCI as appropriate),applied for at least 14 days (or for the maximum duration recommended by the product prescribing information or local guidelines, whichever is shorter). - Subjects with any previous systemic treatment for prurigo nodularis or phototherapy for prurigo nodularis, independent of response, are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout. *Systemic treatment for prurigo nodularis is defined as those systemic and biologic treatments listed in Table 6-3. 7.Subject must have completed at least 4 days of daily diary entries within the 7 days preceding and including day 1 prerandomization.
Exclusion criteria
Exclusion criteria: 1.Skin or systemic morbidities, other than prurigo nodularis, that have been active or requiring treatment within the last 3 months, that interfere with the assessment of study outcomes, including but not limited to: (1) atopic dermatitis (signs or symptoms other than dry skin or requiring treatment is not allowed; use of emollients and/or history of AD is allowed) (2) a-1 antitrypsin deficiency (3) bullous autoimmune disease (4) coeliac disease (5) cholestatic liver disease (eg, primary biliary cirrhosis) (6) contact dermatitis (7) folliculitis (8) habitual picking/excoriation disorder (9) hidradenitis suppurativa (10) insect bites (11) iron deficiency anemia (12) lichen planus (13) lichen simplex chronicus (14) obstructive biliary disease (15) psoriasis (16) scabies (17) uncontrolled thyroid disease (18) venous stasis; 2.Prurigo nodularis secondary to medications. 3.Prurigo nodularis secondary to neurologic or psychiatric medical conditions (eg, notalgia paresthetica, brachioradial pruritus, neurotic excoriations, obsessive compulsive disorder, delusional parasitosis). 4.Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma). 5.History of major immunologic reaction (eg, serum sickness, anaphylaxis, or anaphylactic reaction) to any other biologic product or any excipient of rocatinlimab. 6.Known sensitivity to any of the products or components to be administered during dosing. 7.Diagnosis of a helminth parasitic infection within 6 months prior to day 1 prerandomization that had not been treated with or had failed to respond to standard of care therapy. 8.Evidence of human immunodeficiency virus (HIV) infection or positive for HIV antibodies at initial screening or current acquired, common variable or inherited, primary or secondary immunodeficiency. 9.Positive for hepatitis C virus (HCV) antibody at initial screening with confirmed positive HCV RNA. 10.Active and non-virally suppressed hepatitis B infection at initial screening, defined as detectable hepatitis B DNA polymerase chain reaction (PCR) test in a subject with detectable hepatitis B Surface Antigen (HBsAg) and/or antibodies to hepatitis B core (anti-HBc). Subjects with detectable HBsAg are required to be virally suppressed with an approved hepatitis B antiviral therapy during the study (For sites and subjects participating in the European Economic Area [EEA], please refer to Section 11.9 Appendix 9). 11.Positive or indeterminate QuantiFERON GOLD from central laboratory at initial screening. (1) Exception: A positive or indeterminate QuantiFERON test is allowed if ALL of the following are present at day 1 prerandomization per Screening Tuberculosis (TB) Risk Assessment Questionnaire provided by Amgen: (2) no symptoms of TB (3) documented history of a completed course of adequate prophylaxis (completed treatment for latent TB per local standard of care prior to start of investigational product) (4) no known exposure to a case of active TB after most recent prophylaxis (5) no evidence of active TB on chest radiograph (chest X-ray or computer tomography) obtained within 3 months prior to day 1 prerandomization For sites and subjects participating in the EEA, please refer to Section 11.9 (Appendix 9). 12.Active chronic or acute infection requiri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WI-NRS; | — |
Secondary
| Measure | Time frame |
|---|---|
| IGA-CNPG S; | — |
Countries
China
Contacts
Public ContactHang Li
Peking University First Hospital
Outcome results
None listed