Open‐label, investigator‐initiated, single‐site exploratory trial evaluating secukinumab, an anti‐interleukin‐17A monoclonal antibody, for patients with moderate‐to‐severe hidradenitis suppurativa

2019 ◽  
Vol 181 (3) ◽  
pp. 609-611 ◽  
Author(s):  
L. Prussick ◽  
B. Rothstein ◽  
D. Joshipura ◽  
A. Saraiya ◽  
Y. Turkowski ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Hidradenitis Suppurativa ◽  
Single Site ◽  
Open Label ◽  
Exploratory Trial ◽  
Interleukin 17A

A 52-week, open-label study of the efficacy and safety of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with chronic plaque psoriasis

2014 ◽  
Vol 71 (6) ◽  
pp. 1176-1182 ◽  
Author(s):  
Kenneth B. Gordon ◽  
Craig L. Leonardi ◽  
Mark Lebwohl ◽  
Andrew Blauvelt ◽  
Gregory S. Cameron ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Plaque Psoriasis ◽  
Efficacy And Safety ◽  
Chronic Plaque Psoriasis ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Interleukin 17A

scholarly journals Efficacy and safety of netakimab, anti-IL-17A monoclonal antibody, in patients with ankylosing spondylitis. Results of phase III international, multicenter, randomized double-blind clinical trial BCD-085-5/ASTERA

2020 ◽  
Vol 58 (4) ◽  
pp. 376-386 ◽  
Author(s):  
V. I. Mazurov ◽  
I. Z. Gaydukova ◽  
Sh. Erdes ◽  
T. V. Dubinina ◽  
A. M. Pristrom ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Ankylosing Spondylitis ◽  
Safety Profile ◽  
Total Duration ◽  
Spinal Pain ◽  
Phase Iii ◽  
Duration Of Treatment ◽  
Open Label ◽  
Double Blind ◽  
Interleukin 17A

Netakimab (NTK) is a humanized monoclonal antibody targeting interleukin-17A.Objective. The main objective of BCD-085-5/ASTERA study was to prove superiority of NTK over placebo and assess its’ safety in patients with active AS.Subjects and methods. BCD-085-5/ASTERA was a double-blind, multicenter, randomized, placebo-controlled, phase III study, which included 228 adult patients with active AS, persisting despite active treatment with NSAIDs. AS was considered active at BASDAI score ≥ 4.0. Patients were blindly randomized (1:1) to receive subcutaneous injections of NTK (120 mg) or placebo at weeks 0, 1, 2 and then every other week up to week 14. Starting from week 16 all patients from NTK group and patients from placebo group not achieving ASAS20 were switched to open label 120 mg NTK s/c once every two weeks. The total duration of treatment with NTK was 3 years.Results. Higher proportion of patients had ASAS40 response at week 16 (primary endpoint) in NTK arm compared to placebo (40,4 vs 2,6%, р <0,0001, 95% CI [27,4%; 48,1%]). Spinal pain subsided and laboratory inflammation markers decreased within one week after the first NTK injection. NTK safety profile was comparable to that of placebo. The most common for NTK adverse events were neutropenia (7,0%) and ALT increase (6,1%).Conclusion. Subcutaneous NTK at 120 mg dose demonstrated superior efficacy vs placebo, with fast onset of response and favorable safety profile when used in patients with ankylosing spondylitis. 

Continuous Weekly Adalimumab is the Optimal Long-Term Strategy for Patients with Moderate-to-Severe Hidradenitis Suppurativa: Results from the PIONEER Open Label Extension Trial

2017 ◽  
Vol 1 ◽  
pp. s129
Author(s):  
Alexa B Kimball ◽  
Martin M Okun ◽  
Gerit Mulder
Keyword(s):  
Hidradenitis Suppurativa ◽  
Open Label ◽  
Open Label Extension ◽  
Extension Trial

Abstract Not Available Disclosures: Study supported by AbbVie.

scholarly journals A phase Ib, open-label, dose-escalation trial of the anti-CD37 monoclonal antibody, BI 836826, in combination with gemcitabine and oxaliplatin in patients with relapsed/refractory diffuse large B-cell lymphoma

2021 ◽  
Author(s):  
Monica Balzarotti ◽  
Massimo Magagnoli ◽  
Miguel Ángel Canales ◽  
Paolo Corradini ◽  
Carlos Grande ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
B Cell ◽  
Dose Escalation ◽  
Cell Lymphoma ◽  
Human Monoclonal Antibody ◽  
B Cell Lymphoma ◽  
Chimeric Mouse ◽  
Open Label ◽  
Large B Cell Lymphoma ◽  
Large B Cell

SummaryBackground BI 836826 is a chimeric mouse–human monoclonal antibody directed against human CD37, a transmembrane protein expressed on mature B lymphocytes. This open-label, phase I dose-escalation trial (NCT02624492) was conducted to determine the maximum tolerated dose (MTD), safety/tolerability, and preliminary efficacy of BI 836826 in combination with gemcitabine and oxaliplatin in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Methods Eligible patients received intravenous infusions of BI 836826 on day 8 and gemcitabine 1000 mg/m2 plus oxaliplatin 100 mg/m2 on day 1, for up to six 14-day treatment cycles. Dose escalation followed the standard 3 + 3 design. Results Of 21 treated patients, 17 had relapsed/refractory DLBCL and four had follicular lymphoma transformed to DLBCL. BI 836826 dosing started at 25 mg and proceeded through 50 mg and 100 mg. Two dose-limiting toxicities (DLTs) occurred during cycle 1, both grade 4 thrombocytopenia lasting > 7 days, affecting 1/6 evaluable patients (17%) in both the 50 mg and 100 mg cohorts. Due to early termination of the study, the MTD was not determined. The most common adverse events related to BI 836826 treatment were neutropenia (52%), thrombocytopenia (48%), and anemia (48%). Eight patients (38%) experienced BI 836826-related infusion-related reactions (two grade 3). Overall objective response rate was 38%, including two patients (10%) with complete remission and six patients (29%) with partial remission. Conclusions BI 836826 in combination with GemOx was generally well tolerated but did not exceed the MTD at doses up to 100 mg given every 14 days.

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