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New Drugs Online Report for tildrakizumab
Information
Generic Name:
tildrakizumab 
Trade Name:  
Synonym: SCH 900222, MK-3222 
Entry Type: New molecular entity  
 
Developmental Status
UK: Phase III Clinical Trials 
EU: Phase III Clinical Trials 
US: Phase III Clinical Trials 
UK launch Plans: Available only to registered users
Actual UK launch date:  
Comments
Nov 12: PIII programme starts Dec 12 [1]. 
22/11/2012 09:37:27
 
Trial or other data
NCT01936688 is a 28-week, PIII, randomized, active comparator (etenercept) and placebo-controlled study to evaluate the efficacy and safety/tolerability of subcutaneous MK-3222 (100 or 200mg), followed by an optional long-term safety extension study (a further 192 weeks), in 1050 subjects with moderate-to-severe chronic plaque psoriasis (Protocol No. MK-3222-012). The primary outcome is PASI-75 and a PGA score of clear or minimal with ≥2 grade reduction at week 12. The study starts Sep 13 and is due to complete Oct 19 (primary outcome data collection Jul 2014 [2]. 
24/09/2013 17:45:28
Nov 12: NCT01729754 is a 52-week, PIII, randomized, active comparator and placebo-controlled study of tildrakizumab, followed by an optional long-term safety extension study, in 1,050 subjects with moderate-to-severe chronic plaque psoriasis. The study is in 3 parts: in part 1 (Week 0 to 12) there are 4 arms: tildrakizumab 200mg or 100mg, etanercept placebo or etanercept 50mg; in part 2 (Week 12 to 28), patients originally on etanercept placebo will be re-randomised to tildrakizumab every 12 weeks and those on etanercept 50mg will continue; in part 3 (Week 28 to 52), subjects on tildrakizumab will be re-randomised to tildrakizumab 100 or 200mg, or treatment discontinued, depending on PASI response. Those on etanercept without a PASI 75 response will transfer to tildrakizumab. Eligible participants who enroll in the extension study will have an additional treatment period of up to 192 weeks and followed for an additional 20 weeks. They will receive tildrakizumab100mg or 200mg (whichever they were on in part 3) every 12 weeks up to study Week 244 according. The primary outcomes are: PASI 75 response and PGA score of clear or minimal with ≥2 grade reduction from baseline, both at 12 weeks; and number of patients having AEs or discontinuing therapy because of AEs up to weeks 12 and 244. The study starts Jan 13 and is due to complete Jul 19 (primary data collection Jun 15) [1]. 
22/11/2012 10:58:33
Nov 12: NCT01722331 is a 64-week, PIII, randomized, placebo-controlled of subcutaneous tildrakizumab, followed by an optional long-term safety extension study, in 885 subjects with moderate-to-severe chronic plaque psoriasis (Protocol No. MK-3222-010). The primary outcomes are: the proportion of patients achieving a PASI 75 score and a Physician´s Global Assessment (PGA) score of clear or minimal with ≥2 grade reduction from baseline, both at 12 weeks; and number of patients having AEs or discontinuing therapy because of AEs to day 246. MK-3222 will be given at 1 dose of 100mg or 200mg at weeks 0 and 4 then every 12 weeks. Inclusion criteria include: candidate for phototherapy or systemic therapy; and for the extension study subjects must have completed Part 3 of the base study and achieved ≥PASI-50 response. The study starts Dec 12 and is due to complete Mar 19 [1]. 
22/11/2012 09:37:01
   
References  
Available only to registered users
Category
BNF Category:
Preparations for eczema and psoriasis (13.05)
Pharmacology: monoclonal antibody, interleukin-23 (IL-23) inhibitor  
Epidemiology: Prevalence is thought to vary among ethnic groups, with a higher prevalence among Scandinavian populations. Approximately 2% of Europeans have psoriasis: plaque psoriasis is the most common type, representing 90% of cases  
Indication: Psoriasis 
Additional Details:  
 
Method(s) of Administration
Subcutaneous 
 
Company Information
Name: Merck Sharp & Dohme 
US Name: Merck Sharp & Dohme 
 
NICE Information
Anticipated Commissioning route (England)
In timetable: -  
   

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