Crohn's Disease Forum » Books, Multimedia, Research & News » QuBiologics new phase 2 trial recruiting soon


02-05-2018, 05:12 PM   #1
Mommabear
 
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QuBiologics new phase 2 trial recruiting soon

Calling all Canadians! I got this communiqué from QuBiologics and wanted to share:

"We're getting closer to the launch of our #Canadian phase 2 clinical trial for adults with moderate to severe #CrohnsDisease (www.quibd.com).

If you live in #Canada, think you'd like to participate and want more info, sign up here and say "Yes, please" http://ow.ly/ihIl30i1Sif"

Good Luck!
02-09-2018, 07:26 PM   #2
Lady Organic
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I have contacted the team today and waiting for an answer on when it starts, how we qualify and if traveling expenses are still paid. I think they were right?

I may be interested if participation is not too regular and complicated for an out of province patient. I think they have 4 points of services now if Im correct, but none in Québec.
__________________
''UC-like Crohn's'' (2001)
wrists + ankles arthropathies (2013)
on: 50mg 6-MP (Purinethol)+ B12 shots


Diet: ''IBD-AID'' : http://www.nutritionj.com/content/13/1/5+ organic food only
suppl Curcuminoid extract, Inulin,psyllium, apple pectin, Vitamin D

past meds:
pred 50mg, 5-ASA (pill, rectal), cortifoam, Imuran, Purinethol, methotrexate.
02-18-2018, 11:26 AM   #3
Mommabear
 
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Good luck to you Lady Organic! I hope you can participate!
02-19-2018, 06:52 AM   #4
Lady Organic
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I sent an email 10 days ago and havent had a reply from them yet. I'll try another address or will try to reach them over the phone this week. Thanks!
02-19-2018, 10:43 AM   #5
Crispix73
 
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I hope you get into the trial! I really think this is one of the most promising drugs in development right now. I’d love to get feedback and updates from someone actually participating in the trial.

I pray this makes it through the development process and gets approved in the future.

Good luck, and keep us updated!
02-22-2018, 09:51 AM   #6
Mommabear
 
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Lady Organic, did you see that they are having a webinar about the trial?

“Sign up for our webinar & join Dr. Hal Gunn on Monday March 5th 2018 at 4 pm PST (7 PM EST) to learn more about the trial design and the inclusion/exclusion criteria. There will be a 30 minute presentation followed by 30 minute Q&A session.

Just send us an email to [email protected] with the word "Webinar" in the subject line and we'll register you and send log-in information to participate.“
02-22-2018, 10:40 PM   #7
Lady Organic
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Yes thanks, I received that email back too... I was hoping the trial would open soon, but I feel it will not be so soon...
03-06-2018, 07:50 PM   #8
Lady Organic
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I attended the webinar yesterday. It was interesting but we couldnt hear all the answers from Dr Gunn due to sound system difficulties. Hopefully, there will be a transcript soon of the webinar.

The upcoming CD trial will start this month with 20 first Canadian participants who will all receive the real medication for 1 year.

A second arm will start short after in the fallowing months with 150 participants if i remember correct. 2/3 will receive the medication for 1 year and 1/3 the placebo. Unfortunately the placebo arm wont have the chance to receive the real medication down the road. Americans will be allowed for this trial if I understood correctly.

Disease must be classified from moderate to severe based on a colonoscopy and evaluation of clinical symptoms of the trial experimentors.

I asked the question if the treatment could help extraintestinal manifestions, such as arthritis, and the answer was ''no''. Dr Gunn answered that QBCO was gut specific.

I also asked the question if participants who would respond positively could pursue the treatment as a compassionate treatment after the trial and he answered that he would try to get approval from Health Canada.

Dr. Gunn mentioned that it would take at least 4 years before possible commercialization of the treatment.
03-06-2018, 09:11 PM   #9
Mommabear
 
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Thank you Lady Organic! I wonder though, if it puts you in remission whether that would help the other manifestations of the disease, even if the treatment is gut specific, since everything is tied together. Do you think you will try it?
03-06-2018, 10:36 PM   #10
Lady Organic
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With all the patients he already fallowed in previous trials, i think he responded knowing it didnt help many patients. But that's just my feeling... Especially for those of us whose EIMs run independantly of disease activity, thats even less of a possibility I believe.
At this point, I would not qualify as I just reached remission on prednisone. So I could wait for the 150 -patients arm in case of relapse, but having a 1 out 3 chances of not receiving the treatment is not something I am much interested in. i am highly reluctant letting my disease going to moderate in order to have a chance to participate as well. I have become highly protective of my colon and I manage to not letting things go out of control. I want to get things under control before it reaches moderate level of disease activity and live minimal suffering and anxiety. If I relapse again, I am most likely going to go on Humira, stelara or vedolizumab and want fast intervention.
03-07-2018, 05:32 AM   #11
Crohn2357
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Qu Biologics uploaded this on youtube:

https://www.youtube.com/watch?v=leVU...ature=youtu.be
10-29-2018, 12:21 PM   #12
Hal Gunn
 
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Hello,

Thank you for your continuous interest in Qu Biologic's investigational treatment QBECO Site Specific Immunomodulator (SSI). I would like to provide an update on RESTORE, our ongoing phase 2 clinical trial.

• Currently enrolling patients with moderate-to-severe Crohn’s disease

• The study will enroll a total of 20 participants in 3 sites located in Vancouver, BC; New Westminster, BC and Hamilton, ON.

• The study is open-label meaning that everyone receives QBECO investigational treatment for 52 weeks.

• Study related travel will be paid for by Qu Biologics and the study investigational drug, QBECO, and procedures are provided at no cost to participants.

• Anyone who is interested in joining the RESTORE study is invited to find out if they may be eligible by filling out a simple questionnaire at www.restoretrial.ca. Specific questions about RESTORE can be directed to the study’s recruitment nurse Andrea Cameron by email ([email protected]) or phone (1-877-223-8637).

Best wishes!
11-08-2018, 09:27 AM   #13
Lady Organic
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Thank you so much Dr Gunn for the update.

I am relapsing right now. I am highly tempeted to try to enroll. This may be my chance. I'll reach the nurse next week for a discussion.
Thanks a lot!
11-09-2018, 06:29 AM   #14
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Exciting news although it a bit of a disappointment to hear the it won't be commercialised for another 4 years. I hoping it was going to be more like 2 years at this stage...
11-15-2018, 12:50 PM   #15
gohabsgo
 
Join Date: Dec 2011
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Hey everyone, I am in the study. I have given my self my 8th injection. So far I have noticed a slight reduction in bowel movements. Also the overall pain factor has started to decrease. I will keep everyone posted on how I am doing. HOPEFULLY,me being a lab rat will help bring some light at the end of the tunnel for all of us.

The study is for 56 weeks. I hope by this time next year I am home free.

Two of the requirements for the study are you cant be on and(and I think) you can never have taken a biologic. You also can never have had any surgery. They will ask you over the phone all the other questions needed to make sure you qualify. If you do qualify be prepared to be treated as a lab rat. Lots of blood and stool tests before you go into the study.

Tom
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