scholarly journals Efficacy of a dengue vaccine candidate (TAK-003) in healthy children and adolescents two years after vaccination

2020 ◽  
Author(s):  
Eduardo López-Medina ◽  
Shibadas Biswal ◽  
Xavier Saez-Llorens ◽  
Charissa Borja-Tabora ◽  
Lulu Bravo ◽  
...  
Keyword(s):  
Age Groups ◽  
Healthy Children ◽  
Rt Pcr ◽  
Dengue Vaccine ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Second Year ◽  
To Receive ◽  
Ongoing Phase

Abstract Background Takeda’s dengue vaccine is under evaluation in an ongoing Phase 3 efficacy study; we present an update after 2 years. Methods 20,099 children (4–16 years old) were randomized to receive two doses of TAK-003 or placebo three months apart and are under long-term febrile surveillance to detect dengue by serotype-specific RT-PCR. (NCT02747927). Results Cumulative efficacy against dengue over ~27 months since first dose was 72.7% (95% CI: 67.1 – 77.3), which included efficacy of 67.0% (95% CI: 53.6 – 76.5) in dengue-naïve and 89.2% (82.4 – 93.3) against hospitalized dengue. In the second year after vaccination, a decline in efficacy was observed [56.2% (42.3 – 66.8)] with the largest decline in 4 – 5 year-old children [24.5% (-34.2 – 57.5)]; efficacy was 60.6% (43.8 – 72.4) in 6 – 11 year and 71.2% (41.0 – 85.9) in 12 – 16 year age groups. As TAK-003 efficacy varies by serotype, changes in serotype dominance partially contributed to the efficacy differences in year by year analysis. No related serious adverse events occurred during the second year. Conclusion TAK-003 demonstrated continued benefit independent of baseline serostatus in reducing dengue with some decline in efficacy during the second year. Three-year data will be important to see if efficacy stabilizes or declines further.

scholarly journals Three years efficacy and safety of Takeda’s dengue vaccine candidate (TAK-003)

2021 ◽  
Author(s):  
Luis Rivera ◽  
Shibadas Biswal ◽  
Xavier Sáez-Llorens ◽  
Humberto Reynales ◽  
Eduardo López-Medina ◽  
...  
Keyword(s):  
Vaccine Candidate ◽  
Efficacy And Safety ◽  
Dengue Vaccine ◽  
Serious Adverse Events ◽  
Post Vaccination ◽  
Safety Risks ◽  
Long Term Follow Up ◽  
To Receive

Abstract Background Takeda’s live attenuated tetravalent dengue vaccine candidate (TAK-003) is under evaluation in a long-term clinical trial across eight dengue-endemic countries. Previously, we have reported its efficacy and safety in both seronegative and seropositive participants and that its performance varies by serotype, with some decline in efficacy from first to second year post-vaccination. This exploratory analysis provides an update with cumulative and third year data. Methods Healthy 4–16 year-olds (n=20,099) were randomized 2:1 to receive TAK-003 or placebo (0, 3 month schedule). The protocol included baseline serostatus testing of all participants and detection of all symptomatic dengue throughout the trial with a serotype specific RT-PCR. Results Cumulative efficacy after three years was 62.0% (95% confidence interval: 56.6%, 66.7%) against virologically-confirmed dengue (VCD) and 83.6% (76.8%, 88.4%) against hospitalized VCD. Efficacy was 54.3% (41.9%, 64.1%) against VCD and 77.1% (58.6%, 87.3%) against hospitalized VCD in baseline seronegatives, and 65.0% (58.9%, 70.1%) against VCD and 86.0% (78.4%, 91.0%) against hospitalized VCD in seropositives. Efficacy against VCD during the third year declined to 44.7% (32.5%, 54.7%), while efficacy against hospitalized VCD was sustained at 70.8% (49.6%, 83.0%). Rates of serious adverse events were 2.9% in TAK-003 group and 3.5% in placebo group during the ongoing long-term follow-up (i.e. second half of the three years following vaccination), but none were related. No important safety risks were identified. Conclusions TAK-003 was efficacious against symptomatic dengue over three years. Efficacy declined over time but remained robust against hospitalized dengue. A booster dose evaluation is planned.

scholarly journals Long-term Safety and Immunogenicity of a Tetravalent Dengue Vaccine Candidate in Children and Adults: A Randomized, Placebo-Controlled, Phase 2 Study

2020 ◽  
Author(s):  
Chukiat Sirivichayakul ◽  
Elizabeth A Barranco-Santana ◽  
Inés Esquilín Rivera ◽  
Jennifer Kilbury ◽  
Marsha Raanan ◽  
...  
Keyword(s):  
Vaccine Candidate ◽  
Controlled Trial ◽  
Natural Infection ◽  
Neutralizing Antibody ◽  
Healthy Children ◽  
Phase 2 ◽  
Dengue Vaccine ◽  
Serious Adverse Events ◽  
Antibody Titers

Abstract Background We report long-term safety and immunogenicity of Takeda’s tetravalent dengue vaccine candidate (TAK-003) in healthy children and adults living in dengue-endemic areas in Puerto Rico, Columbia, Singapore, and Thailand. Methods In part 1 of this phase 2, randomized, placebo-controlled trial we sequentially enrolled 1.5–45 year olds (n = 148) into 4 age-descending groups, randomized 2:1 to receive 2 doses of TAK-003 or placebo 90 days apart. In part 2, 1–11 year olds (n = 212) were enrolled and randomized 3:1 to TAK-003 or placebo groups. We assessed neutralizing antibody titers for the 4 dengue serotypes (DENV) up to month 36 in part 1, and symptomatic dengue and serious adverse events (SAEs) up to month 36 in both parts. Results At month 36, seropositivity rates were 97.3%, 98.7%, 88.0% and 56.0% for DENV-1, -2, -3 and -4, respectively. Seropositivity rates varied significantly for DENV-4 according to serostatus at baseline (89.5% in seropositives versus 21.6% in seronegatives). No vaccine-related SAEs were reported. Conclusions The trial demonstrated persistence of neutralizing antibody titers against TAK-003 over 3 years in children and adults living in dengue-endemic countries, with limited contribution from natural infection. TAK-003 was well tolerated. Clinical Trials Registration NCT01511250

scholarly journals A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Miwa Haranaka ◽  
James Baber ◽  
Yoichiro Ogama ◽  
Masako Yamaji ◽  
Masakazu Aizawa ◽  
...  
Keyword(s):  
Adverse Events ◽  
Phase 1 ◽  
Geometric Mean ◽  
Randomized Study ◽  
Age Groups ◽  
Serious Adverse Events ◽  
Robust Immune Response ◽  
Japanese Adults ◽  
To Receive ◽  
Ongoing Phase

AbstractWe report interim safety and immunogenicity findings from an ongoing phase 1/2 study of BNT162b2 in healthy Japanese adults. Participants were randomized 3:1 to receive 2 intramuscular injections of 30 μg BNT162b2 or placebo 21 days apart. Overall, 160 individuals were randomized: 119 received BNT162b2, and 41 received placebo. Participants were stratified by age: 20–64 years (n = 130) and 65–85 years (n = 30). More than 97% of BNT162b2 recipients received 2 doses. Local reactions and systemic events were generally transient and mild to moderate. Severe adverse events were uncommon; there were no serious adverse events. One month after dose 2, SARS-CoV-2 50% serum neutralizing geometric mean titers were 571 and 366, and geometric mean fold rises were 55.8 and 36.6, in the younger and older age groups, respectively. In summary, BNT162b2 has an acceptable safety profile and produces a robust immune response, regardless of age, in Japanese adults. (ClinicalTrials.gov, NCT04588480).

scholarly journals Evaluating the Long-Term Efficacy of COVID-19 Vaccines

2021 ◽  
Author(s):  
Dan-Yu Lin ◽  
Donglin Zeng ◽  
Peter B Gilbert
Keyword(s):  
Large Scale ◽  
Crossover Designs ◽  
Phase 3 ◽  
Term Efficacy ◽  
Timely Access ◽  
Efficacious Vaccine ◽  
Trial Participants ◽  
Ongoing Phase

Abstract Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic.1−3 However, the high vaccine efficacy (VE) reported by ongoing phase 3 placebo-controlled clinical trials is based on a median follow-up time of only about two months4−5 and thus does not pertain to long-term efficacy. To evaluate the duration of pro- tection while allowing trial participants timely access to efficacious vaccine, investigators can sequentially cross participants over from the placebo arm to the vaccine arm according to priority groups. Here, we show how to estimate potentially time-varying placebo-controlled VE in this type of staggered vaccination of participants. In addition, we compare the per- formance of blinded and unblinded crossover designs in estimating long-term VE.

scholarly journals Seroconversion rates following 2 doses of measles- mumps- rubella vaccination given at the ages 12 and 18 months: data for possible additional dose at older age

2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Hana Saffar ◽  
Sayed Jaber Mousavi ◽  
Hiva Saffar ◽  
Mohammad-Reza Parsaei ◽  
Gholam-Reza Ghorbani ◽  
...  
Keyword(s):  
Immune Responses ◽  
Age Groups ◽  
High Rate ◽  
Healthy Children ◽  
Mmr Vaccine ◽  
Vaccine Failure ◽  
Iranian Children ◽  
Rubella Vaccination ◽  
Infant Pair

Abstract Background Despite high rate of vaccination coverage with 2-doses of measles containing vaccine among Iranian children, outbreaks of measles occurred among different age groups and fully vaccinated subjects. Although the main reason for these outbreaks is unknown, however, vaccine failure was supposed to be an important cause. This study was designed to determine the seroconversion rates to measles- mumps- rubella (MMR) vaccine currently in use among Iranian children. Methods This prospective study was conducted among healthy children older than 12 months who were candidates of scheduled MMR vaccination. Blood samples were obtained from each mother- infant pair just before vaccination, and from infants 4–6 weeks after MMR1 and MMR2 immunization. Collected sera were tested for specific lgG antibodies against MMR agents using ELISA method. The proportion of seroprotected subjects among mother- infant pairs before vaccination as well as the prevalence rates of seroconversion after MMR1 and MMR2 vaccination were calculated. Collected data were analyzed using descriptive statistical methods. Results During 22-months study period, 92 mother- infant pairs were participated. Seroimmunity rates against MMR viruses were 85.8%, 84.7% and 86.9% for mothers, and 3.2%, 2.1% and 1.0% for children, respectively. After MMR1 vaccination from 52 seronegative children, 80.7%, 78.8% and 75% were seroconverted. These rates increased to 94.8%, 89.7% and 94.8% after the MMR2 vaccination. Also, the specific immunity was enhanced among seropositive children. Conclusion Majority of the mothers and few infants were immune to MMR viruses prior to MMR1 vaccination. Immune responses detected after MMR1 injection, and overall seroconversion rates achieved after 2-doses of MMR vaccination were less than expected and inadequate to preserve long-term protection against MMR agents.

Rituximab Therapy after Response to R-CHOP Induction Therapy for Patients with Previously Untreated Indolent Non-Hodgkin’s Lymphoma (NHL): Clinical Outcomes and Pharmacokinetics (PK)

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1295-1295
Author(s):  
Louis Fehrenbacher ◽  
Jonathan A. Polikoff ◽  
Robert Hermann ◽  
Haresh Jhangiani ◽  
Jean Bjerke ◽  
...  
Keyword(s):  
Phase Iii ◽  
Open Label ◽  
Community Based ◽  
Serious Adverse Events ◽  
Residual Concentration ◽  
Ann Arbor ◽  
Grade 3 ◽  
To Receive ◽  
Ongoing Phase

Abstract The addition of rituximab (R) therapy significantly improves PFS in patients with relapsedl/refractory disease responding after CHOP as well as responders after R-CHOP induction (van Oers, 2005). The aim of this study was to assess, in patients with previously untreated indolent NHL, the safety, efficacy and PK of additional R therapy in responders to R-CHOP induction. Between 10/01 and 08/06, 102 patients aged 28–84 (mean 57 yr) yrs with Ann Arbor Stage III (28.4%) or IV (71.6%) indolent NHL were treated on this Phase II single-arm, open-label, multi-center, community-based trial. Baseline LDH and β2 microglobulin were above normal in 20.6% and 66.3% of patients, respectively. Treatment consisted of 6 cycles of R-CHOP (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2, and doxorubicin 50 mg/m2 all IV on Day 1 of each 21-day cycle; prednisone 100 mg/d po Days 1–5; and R 375 mg/m2 IV 2–3 days prior to first dose of CHOP and thereafter on Day 1 of each cycle). Patients with ongoing response (CR/CRu or PR) received R 375 mg/m2 weekly x 4, repeated every 6 months x 2 yrs, for a total of up to 16 R doses, within 28 days after completion of R-CHOP. Median follow-up was 39 mos. ORR after R-CHOP was 86.3% (95% CI: 78.3, 92.1), with CR/CRu 48% (95% CI: 38.0, 58.2). As measured from initiation of R-CHOP, PFS at 2 and 3 yrs was 75.2% (95% CI: 64.0, 83.3) and 67.3% (95% CI: 54.6, 77.2), respectively. OS at 2 and 3 yrs was 92.9% (95% CI: 85.7, 96.6) and 89.4% (95% CI: 81.2, 94.2), respectively. Infusion-related toxicity with R given after R-CHOP was less frequent than seen with R-CHOP in this study. The overall incidence of serious adverse events during R therapy given after R-CHOP was 8.5%, including 3 NCI-CTC grade 3/4 events: viral encephalitis (n=1), patellar fracture (n=1) & development of colon cancer (n=1). Serum R concentrations were collected over serial timepoints from 12 patients. Both pre- and end of infusion serum R concentrations were similar across cycles 2–4 of R therapy given after R-CHOP. R concentration was higher just prior to infusion of the first R dose given after R-CHOP due to residual concentration from the R-CHOP treatment. Concentrations were very low (< 10 ug/mL) just prior to initiation of the subsequent R cycles. During R therapy given after R-CHOP, serum R concentrations were similar to those previously reported during R monotherapy treatment (Berinstein, 1998). In summary, this study demonstrated that R therapy given after R-CHOP to be generally well-tolerated, and associated with 75.2% PFS and 92.9% OS at 2 yrs, and 67.3% PFS and 89.4% OS at 3 yrs. Moreover, the current study demonstrates that PK data from R induction can be extrapolated to R given after R-CHOP. The benefit of adding additional R therapy to responders to R-chemotherapy will be addressed in the analysis of the ongoing Phase III PRIMA study, wherein patients with advanced follicular lymphoma who respond to R-chemotherapy induction are randomized to receive further R therapy vs. observation.

scholarly journals Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison

2014 ◽  
Vol 2014 ◽  
pp. 1-11 ◽  
Author(s):  
David H. Adams ◽  
Lu Zhang ◽  
Brian A. Millen ◽  
Bruce J. Kinon ◽  
Juan-Carlos Gomez
Keyword(s):  
Weight Gain ◽  
Adverse Events ◽  
Term Treatment ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Treatment Groups ◽  
Long Term Treatment ◽  
Blind Comparison

We tested the hypothesis that long-term treatment with pomaglumetad methionil would demonstrate significantly less weight gain than aripiprazole in patients with schizophrenia. In this 24-week, multicenter, randomized, double-blind, Phase 3 study, 678 schizophrenia patients were randomized to either pomaglumetad methionil (n=516) or aripiprazole (n=162). Treatment groups were also compared on efficacy and various safety measures, including serious adverse events (SAEs), discontinuation due to adverse events (AEs), treatment-emergent adverse events (TEAEs), extrapyramidal symptoms (EPS), and suicide-related thoughts and behaviors. The pomaglumetad methionil group showed significantly greater weight loss at Week 24 (Visit 12) compared with the aripiprazole group (−2.8 ± 0.4 versus 0.4 ± 0.6;P<0.001). However, change in Positive and Negative Syndrome Scale (PANSS) total scores for aripiprazole was significantly greater than for pomaglumetad methionil (−15.58 ± 1.58 versus −12.03 ± 0.99;P=0.045). The incidences of SAEs (8.2% versus 3.1%;P=0.032) and discontinuation due to AEs (16.2% versus 8.7%;P=0.020) were significantly higher for pomaglumetad methionil compared with aripiprazole. No statistically significant differences in the incidence of TEAEs, EPS, or suicidal ideation or behavior were noted between treatment groups. In conclusion, long-term treatment with pomaglumetad methionil resulted in significantly less weight gain than aripiprazole. This trial is registered with ClinicalTrials.govNCT01328093.

scholarly journals Seroconversion rates following 2 doses of Measles- Mumps- Rubella Vaccination Given at the Ages 12 and 18 Months: Data for possible additional dose at older age

2021 ◽  
Author(s):  
Hana Saffar ◽  
Sayed Jaber Mousavi ◽  
Hiva Saffar ◽  
Mohammad-Reza Parsaei ◽  
Gholam-Reza Ghorbani ◽  
...  
Keyword(s):  
Age Groups ◽  
High Rate ◽  
Healthy Children ◽  
Elisa Method ◽  
Mmr Vaccine ◽  
Vaccine Failure ◽  
Iranian Children ◽  
Rubella Vaccination ◽  
Infant Pair

Abstract Background. Despite high rate of vaccination coverage with 2-doses of measles vaccine among Iranian children, outbreaks of measles occurred among different age groups and fully vaccinated subjects. Although the main reason for these outbreaks is unknown, however, vaccine failure was supposed to be an important cause. This study was designed to determine the immunogenicity of measles- mumps- rubella (MMR) vaccine currently in use among Iranian children.Methods. This prospective study was conducted among ³ 12 month- old healthy children who were candidates of scheduled MMR vaccination. Blood samples were obtained from each mother- infant pair just before vaccination, and from infants 4- 6 weeks after MMR1 and MMR2 immunization. Collected sera were tested for specific lgG antibodies against MMR agents using ELISA method. The proportion of seroprotected subjects among mother- infant pairs before vaccination as well as the prevalence rates of seroconversion after MMR1 and MMR2 vaccination were calculated. Collected data were analyzed using descriptive statistical methods.Results. During 22-months study period, 92 mother- infant pairs were participated. Seroimmunity rates against MMR viruses were 85.8%, 84.7% and 86.9% for mothers, and 3.2%, 2.1% and 1.0% for children, respectively. After MMR1 vaccination of 52 seronegative children, 80.7%, 78.8% and 75% were seroconverted. These rates increased to 94.8%, 89.7% and 92.3% after the MMR2 vaccination. Also, the specific immunity was enhanced among seropositive children.Conclusion. Majority of the mothers and few infants were immune to MMR viruses, prior to MMR1 vaccination. Seroconversion rates detected after MMR1 injection, and overall seroprotection rates achieved after 2-doses of MMR vaccination were less than expected and inadequate to preserve long-term protection against MMR agents.

scholarly journals Persistent and Stable Growth Promoting Effects of Vosoritide in Children With Achondroplasia for up to 2 Years: Results From the Ongoing Phase 3 Extension Study

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A670-A671
Author(s):  
Ravi Savarirayan ◽  
Louise Tofts ◽  
Melita Irving ◽  
William Wilcox ◽  
Carlos A Bacino ◽  
...  
Keyword(s):  
Adverse Events ◽  
Extension Study ◽  
Controlled Study ◽  
Lower Body ◽  
Z Score ◽  
Body Segment ◽  
Phase 3 ◽  
Pivotal Study ◽  
Second Year ◽  
Ongoing Phase

Abstract Objectives: Vosoritide is a potent stimulator of endochondral bone growth and is in development for the treatment of achondroplasia, the most common form of disproportionate short stature. We previously reported on a 52-week, phase 3, pivotal study that demonstrated a highly statistically significant improvement in annualized growth velocity (AGV) when vosoritide was compared to placebo in children with achondroplasia aged 5-18 years (Savarirayan et al, Lancet, 2020). This is an analysis of data after an additional 52 weeks of treatment in the ongoing phase 3 extension study. Methods: After completion of the phase 3 placebo-controlled study, 119 children were enrolled into the extension study, where they all receive open label 15 μg/kg/day vosoritide. AGV, height Z-score and body proportion ratio were analyzed to assess efficacy of vosoritide in children who were treated with vosoritide for up to 2 years. Fifty-eight continued treatment with vosoritide and 61 switched from placebo to vosoritide. Two participants on continuous vosoritide treatment discontinued before the Week 52 timepoint. Four participants on continuous vosoritide treatment and 7 participants who switched from placebo to vosoritide missed the Week 52 assessment due to Covid-19. Results: In children randomized to receive daily vosoritide, baseline mean (SD) AGV was 4.26 (1.53) cm/year. After the first 52 weeks of treatment, mean (SD) AGV was 5.67 (0.98) cm/year. Mean (SD) AGV over the second year was 5.57 (1.10) cm/year. Mean (SD) change from baseline in height Z-score improved by +0.24 (0.31) at Week 52 in the pivotal study and +0.45 (0.56) at Week 52 in the extension study. Mean (SD) upper-to-lower body segment ratio improved with a change from baseline of -0.03 (0.11) at Week 52 in the pivotal study and -0.09 (0.11) at Week 52 in the extension study. In children who switched from placebo to vosoritide after 52 weeks, baseline AGV was 4.06 (1.20) cm/year and 3.94 (1.07) cm/year after 52 weeks on placebo. In the second year, after receiving 52 weeks of vosoritide, mean AGV was 5.65 (1.47) cm/year, the mean (SD) change in height Z-score was +0.24 (0.34), and the change in upper-to-lower body segment ratio was -0.03 (0.08). No new adverse events associated with vosoritide treatment were detected with up to 2 years of continuous daily, subcutaneous treatment. Most adverse events were mild and no serious adverse events were attributed to vosoritide. The most common adverse event remains mild and transient injection site reactions. Conclusions: The effect of vosoritide administration on growth as measured through AGV and height Z-score was maintained for up to 2-years in children with achondroplasia aged 5 to 18 years, with an improvement of body proportions.

scholarly journals DESTINATION: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the long-term safety and tolerability of tezepelumab in adults and adolescents with severe, uncontrolled asthma

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Andrew Menzies-Gow ◽  
Sandhia Ponnarambil ◽  
John Downie ◽  
Karin Bowen ◽  
Åsa Hellqvist ◽  
...  
Keyword(s):  
High Dose ◽  
Treatment Cessation ◽  
Uncontrolled Asthma ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Long Term Treatment ◽  
To Receive

Abstract Background Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. The efficacy, safety and oral corticosteroid-sparing potential of tezepelumab are being investigated in two ongoing, phase 3, randomized, double-blind, placebo-controlled studies (NAVIGATOR [NCT03347279] and SOURCE [NCT03406078]). DESTINATION (NCT03706079) is a long-term extension (LTE) of these studies. Methods DESTINATION is a randomized, double-blind, placebo-controlled LTE study in adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma who are receiving treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without oral corticosteroids. The study population will comprise patients who complete the 52- and 48-week NAVIGATOR and SOURCE studies, respectively. Patients who were randomized to receive tezepelumab 210 mg every 4 weeks (Q4W) in either predecessor study will continue to receive this regimen for 1 year; those who were previously randomized to receive placebo will be re-randomized (1:1) to receive either tezepelumab 210 mg Q4W or placebo for 1 year. Patients will receive their prescribed controller medications throughout DESTINATION and study physicians will have the opportunity to down- or up-titrate dosage of these medications, if appropriate. The primary objective is to evaluate the long-term safety and tolerability of tezepelumab over 104 weeks (inclusive of the treatment period of either predecessor study). The secondary objective is to assess the long-term effect of tezepelumab on asthma exacerbations. Patients recruited from SOURCE will be followed up post-treatment for 12 weeks. Patients recruited from NAVIGATOR who complete 100 weeks of tezepelumab treatment will be eligible for either 12 weeks of follow-up or a 36-week extended follow-up during which the clinical benefit of tezepelumab after treatment cessation will be investigated. Discussion DESTINATION will evaluate the long-term safety, tolerability and efficacy of tezepelumab versus placebo with continued dosing for up to 2 years. DESTINATION will also evaluate the clinical effect of tezepelumab after treatment cessation. This LTE study aims to elucidate the long-term safety implications of receiving tezepelumab and to assess its potential long-term treatment benefits in patients with severe, uncontrolled asthma. Trial registration NCT03706079 (ClinicalTrials.gov). Registered 15 October 2018.

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