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    • #25879
      Pete Besio
      Participant

      All,

      I have been involved in the Galapegos GPLG1690 “Isabella” clinical trial since late August 2020.  This is a Phase 3 trial, details can be found here:

      https://www.clinicaltrials.gov/ct2/show/NCT03711162?id=NCT03832946+OR+NCT03955146+OR+NCT03538301+OR+NCT03733444+OR+NCT03711162+OR+NCT03727802+OR+NCT03287414+OR+NCT03727451+OR+NCT02019641+OR+NCT03142191&draw=2&rank=6&load=cart

      My purpose in posting this is to encourage anyone interested in clinical trials to see if this trial is a fit for them.  As part of this trial, I receive spirtometry tests (including DLCO 3 times), HiRES CT Scans, and I monthly consultation with an MD that specializes in IPF.  There are 2 iterations of this trial ongoing, and I believe they are both still actively enrolling (one arm is closer to being full than the other).  It is a 52 week trial, last I checked there were still a lot of openings.  My ulterior motive in drawing attention to it is to try to get the trial filled, as the drug won’t make it to market until the trial is over.  While not knowing if I am on the medication or the placebo, when I reported to my clinical nurse how i feel, she indicated that many of the study participants are reporting similar improvements.  The clinic that I am working with if very bullish on this medication.  Unfortunately, I believe this is a US only trial, but there are hundreds of locations enrolling.  Each iteration of the trial can be found at clinicaltrials.gov by searching for IPF studies that are recruiting in the United States. Happy to answer any questions you may have.

      Pete Besio

    • #25885
      Donald Salzberg MD
      Participant

      Hello Pete. I spoke with a research coordinator at Yale University who filled me in on the Galapagos trial. I am currently on OFEV (2 years) and (thank God) I have been very stable at age 65!  I am considering joining the trial but the first two months involves a few visits and I’m planning to finally travel!  If they are still recruiting in February I want to sign up. 2/3 of participants get the drug and 1/3 get placebo. I too hope (if it’s beneficial)!it gets on the market. Likely looking at 2 years from now.  He seemed to think this will be filled up in the next few months. Now that I’ve retired from medicine I should have the time to participate. Thank you for your post. It’s apparently the largest IPF trial to date and bigger than the OFEV/Perfenidone Trials.
      Don Salzberg MD

      • #25962
        Allan Byron
        Participant

        @pbesio

        Hello Pete,

        I am in the UCSF area, and would be interested to enroll as a participant.

        Do u have any idea how i can get hold of anybody to enroll, in the

        Bay Area, where I am?

        Thanks

         

        Allan Byron

         

    • #25888
      Frank Loeffler
      Participant

      @pbesio

      I was diagnosed IPF 4/19 and immediately started OFEV.  In November I was offered the trial GLPG1690-CL-304 so in a month+ it will be a year on both.  I do strictly follow the routine of taking each drug and designated intervals with literally no exception whatsoever.  If the trial Rx is designed to work in conjunction with OFEV, I am hopeful to continue this Rx.  Hopefully the Belgium Rx company will provide information and advice.

      Personally I have little to report.  All of my tests have be stable since 4/19 and I literally do not know how either Rx has impacted me.  I am very thankful that to date I personally have no adverse breathing issues.  For about six weeks starting last March I had diarrhea issues but could not link directly to either Rx (Understanding that the trial Rx may have been placebo).  I do exercise and walk (2-5 miles) daily with no significant change in my breathing or other sensations.

      Pete, at this point, since each individual is different, I am not sure about what to expect in the future.  I am 75 years of age and do tend to my office away from the home daily which may help with sanity.

    • #25898
      john sliwinski
      Participant

      I was selected for the Galapegos trial in Philadelphia and on my first visit they did a cat scan of my lungs and put me through lung function tests. After they got the cat scan results I was disqualified since my lungs were in not that bad of shape for my age (72 years old). I was totally disappointed that I could no longer participate but one has to abide by their rules. However once the trial is over and the drug is approved I will be able to get that Rx.

       

      Good luck to all the participants in their  trial. Please keep us posted on your progress and results.

       

      John S.

    • #25911

      Thank you for sharing John, sorry to hear you were disqualified from the trial but glad it was because your lungs were in good shape vs. the alternative. Still hard to accept though, hopefully the trial yields good results and the Rx will benefit those of us needing it. Like you, I’m curious to hear the results of this trial and other patient’s experiences with it, so I do hope others report back as well 🙂

      Sincerely,
      Charlene.

    • #25918
      Wayne Nelson
      Participant

      I signed up April and now 6 months later never got in and dr dragged his feet and my EKG wasn’t approved! Pray a trial will open up even in another country as desperate at this point!

    • #25937

      Hi Wayne,

      Ah sorry to hear that, so frustrating when we can’t be enrolled in a trial we are optimistic will help! I will also keep my fingers crossed that another trial opens up you can participate in. You’ve likely already heard of this, but did you check out: https://clinicaltrials.gov/ yet? You can filter by disease or location, it might give you some further information about IPF/PF related trials.

      Hang in there!
      Charlene.

    • #25941
      Denny
      Participant

      Thought I would reply here. I was also disqualified at the U of M study of 1690 since my scarring was not bad enough. Watching for other clinical studies too…

       

       

    • #25948

      Thanks so much @pbesio ! I know others will benefit from your experience, and to know you’re there to answer questions. Best wishes on this trial!
      Char.

    • #25961
      Pete
      Participant

      I also did not qualify for this trial because of my CT Scan did not the show the radiologists what they were looking for. I was looking forward to this trial too.

    • #25964
      Richard Phillips
      Participant

      Just a note, I was diagnosed in Nov of 2016 stated on Ofev the same month. I enrolled GPLG study last Nov 2019. My numbers are quite stable. I am also enrolled in the

      University of Florida’s transplant program, to healthy for transplant right now, I am 74

      years old. Cannot tell if I am taking a placebo or not. Only on Oxygen when actually

      real active.

       

    • #25968
      Jackie Kalina
      Participant

      Oh how I hope they come out with a drug that does not make one sick. I’ve only just started on OFEV. Hoping it gets better. I have good days (not normal like old days) and some “(this is a help?)” days. I am still in a “questioning” phase. Why me? Which is exactly what my mother said when she was diagnosed with lung cancer as she was a non-smoker.
      Are you on the trial that is a drug used as an inhalant? Bypassing the digestive tract would be SO great.

    • #25974
      Carol Richards
      Participant

      First, I want to thank Charlene and Mark, our keymasters, for all their help and support on this forum!  I enrolled to be a participant in the GPLG study back in March.  Covid made U of M close enrollment before they could consider me.  When it opened again in August, I was told that the company was no longer enrolling people who were taking OFEV or Esbriet.  They are only taking those that are not on a “Standard of Care” treatment.  I was really looking forward to participating.

      On the subject of side effects of OFEV, I have pretty much tried everything I can to overcome the debilitating diarrhea.  I have seen a Gastroenterologist, a Nutritionist, and contacted OFEV’s very helpful 24/7 helpline.  I have had tests to make sure there is nothing else going on, gone on a strict FODMAP diet, changed my dosage to 1, 150 mg pill, and avoid any dairy at all. I still have problems, but I can function better.  I also have noticed hair loss, and dental sensitivity.  Until I read about those side effects on this forum, I did not connect the dots.  Oh joy.  I am just hoping for some help for all of us, and I am more than willing to be on a clinical trial.  We need to help each other.  Diagnosed in 10/ 2019, and I am 69.

    • #25976

      Sorry to hear that Pete! I know it can be so discouraging… hang in there!
      Char.

    • #25978

      Thanks for sharing with us @richard-phillips! Are you currently listed for transplant at UoF? If so, keeping you in my thoughts! Thanks for sharing your experience with Ofev with us.

    • #25981

      @jackie-leko-kalina,

      Hi Jackie,
      I couldn’t agree more in hoping that a drug could be developed with few (or none at all!) side effects to help manage this disease. Ofev is a really tough drug to be on, Esbriet too I’ve heard though I have no personal experience with it. I had to go off Ofev twice and titrate back on it (at 100mg vs 150mg/dose) before my body would tolerate it, and then I brought Imodium around with me everywhere. I actually didn’t find the oral Imodium helpful, only the sublingual dose (under the tongue) effective. Just a bit of information that might be helpful!

    • #25969
      Jofac O’Handlin
      Participant

      Hello All,

      I can join the list of those rejected from the Galzpagos trial …. but in my case a failure because I could not achieve several of the threshold values.

      This is being done in Liverpool, UK. I attended in November 2019, just ahead of the 5 years cut off time from initial diagnosis.

      First reason was a degree of arrythmia. I have had it from time to time over the years, and as a runner more obvious when fitter. Hadn’t had it for months, but did on the test day.

      Second was the ‘blow out’ test, which required 6 seconds (I think). All of mine gone in 3 or 4, couldn’t hang on till 6.

      Third was the 6 minute walk test. I went into that brim full of confidence. I had practiced outdoors and able, without apparant problems, to do about 600 metres, a short 4 mph. That at a rate that, on the flat, that I felt OK to carry on. In fact where I was testing myself involved a half mile walk there and back. In the test they stopped me at about 100 mtrs as my O2 had dropped below their ‘worry’ value. I felt perfectly happy to go on.

      So I never made it onto the trial. I was extremely disappointed, but seeing the preliminary findings with general improvements for those receiving the treatment, even more galling. Might have been given the placebo!

      As a result I was prescribed oxygen, which was delivered last December, tried the walking pack, a couple of times but decided to leave it till I felt it essential.

      To conclude, have just returned from a 50 minute walk with my wife, about 2.75 miles, including a slow down going up the hill, still without O2. But, I do know that my FVC is declining. So maybe O2 soon …damnation!

      Cheers all,

      Joe.

    • #25993
      Allan Byron
      Participant

      Also called UCSF and they said they are no longer enrolling.

      They said they have two more studies coming. I will inform

      the group, as soon as they notify me.

       

      Allan Byron

    • #25996

      Thank you @abyron888 , much appreciated. Thanks in advance for sharing any information with us that you come across. Char.

    • #26006
      Pete Besio
      Participant

      @abyron888

      There are two arms to this study, UCSF is on the same arm that my clinic is on.  If your interested, there is another arm:

      https://www.clinicaltrials.gov/ct2/show/NCT03711162?id=NCT03832946+OR+NCT03955146+OR+NCT03538301+OR+NCT03733444+OR+NCT03711162+OR+NCT03727802+OR+NCT03287414+OR+NCT03727451+OR+NCT02019641+OR+NCT03142191&draw=2&rank=6&load=cart

      Not sure where your located, assuming CA.  This arm of the study has locations in LA, San Diego, Stanford, and Palm Springs.

      Thanks for posting about the upcoming trials, be interesting to hear of their progress.

       

    • #26014
      William Kracke
      Participant

      I enrolled in the 1690 trial in August 2019 at Yale New Haven. After COVID hit Connecticut mid March of this year they had to stop enrollment and all trial visits until they got COVID under some sort of control. I just had my first trial visit since February. During the no visit period they arranged for local lab blood draws and other safety measurements locally so that they could send trial drug by courier to my home. The drug sponsor modified the study to take COVID into account.  The down side is that they have not completed recruiting yet and the study has participants continue in the study until the last subject completes the year long main portion of the study.  They have committed to offering all successful completers an open label trial with 1690 until drug approval if the study is successful. So it will be another year to year and a half before we find out what we were on and get or continue with the study drug. I am planning on continuing as I am satisfied that Yale is taking all appropriate measures to keep us safe from COVID.

      Before my retirement I worked at Pfizer analyzing drug trials and gained a real appreciation for how important it was to have these trials conducted and the importance that the drug companies place on patient safety.

      Bill K

       

    • #26035
      Richard Phillips
      Participant

      >Charlene, I am not on the waiting list for transplant, still to healthy. I made my one year visit to for the study yesterday. I am going to continue in the study until the last enrollee finishes his last pills. They told me it could be
      another 2 years maybe sooner. My numbers are staying pretty steady. Don’t know
      if I am taking the placebo or the real thing. I am also taking Ofev my understanding is they are no longer taking people are taking the two medicines
      that on the market at this time.
      I was diagnosed 4 years ago this month. Only use oxygen when exercising or
      outside working went on Ofev the first month I was diagnosed. So with 4 years
      of Ofev and one year in the trial study seems like something is working. I don’t
      post must but check in weekly and have gained much info from this site. Keep
      up the good work I sometimes think I have more info than my Dr lol just from
      Reading the pulmonary fibrosis news site.

    • #26038
      Pete Besio
      Participant

      I just checked the enrollment criteria for the Galapagos study, on of the criteria:

      “Subjects receiving local standard of care for the treatment of IPF, defined as either pirfenidone or nintedanib, at a stable dose for at least two months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). A stable dose is defined as the highest dose tolerated by the subject during those two months”.

      So it seems to me that the arm that is still open for enrollment will accept patiens on either Esbriet or Ofev.  My understanding is that the study drug is designed to work in conjunction with Esbriet or Ofev, which is a little disapointing given the side effects we seem to exerience with either of these drugs.

      I am trying to get a feel for how many slots are still open, will post if and when I do.

      • This reply was modified 3 weeks, 4 days ago by Charlene Marshall. Reason: formatting to remove code
    • #26037
      Geoff
      Participant

      G’day I’m in Sydney Australia.On this trial for over a year.No side effects. I think that we are still recruiting in Oz.

      Have been on Esbriet/Pirfenidone for 5+ years. No supp.02.Recent HRCT etc reports say very little progression from initial diagnosis.

      I have every confidence in the drugs.

      Best wishes to all from Geoff.

    • #26046

      Thanks @pbesio, that would be great. We appreciate your efforts on this!

      Sincerely,
      Charlene.

    • #26048

      Hi @geoff,

      So great to hear this, thanks for sharing! I’m really glad the medications aren’t causing you any unpleasant side effects and that the HRCT results are good. I’ll keep my fingers crossed this remains for you, wonderful news. Hello from Canada to one of my favourite places in the world…. Sydney! 🙂
      Char.

    • #26049
      Pete Besio
      Participant

      Per an email exchange with my Galapagos Clinical Research Coordinator today:

      The “arm” that I am participating in (NCT03733444) recently enrolled its 750th and final patient recently, so I will continue in the study until the 750th patient completes THEIR 52 weeks in the study. Galapagos intends to roll over participants into the open label extension of the study.  This extension does NOT include the placebo.  Galapagos has applied for this open label extension, but due to COVID, this submission to the FDA has been delayed. So for now I have about 52 weeks left in the study.

      The clinic I am working with has recently been approved to enroll patients in the other “arm” (NCT03711162).  There are 300 spots still available.  Prospective patients can be taking OFEV, Esbriet, or no standard of treatment to participate.  If you are near Tampa and are interested in participating, I will be happy to provide contact info for the clinic.  I am  impressed with them.

      Other part of the US, there are 117 study locations listed in the information for the trial here:

      https://www.clinicaltrials.gov/ct2/show/NCT03711162?recrs=a&cond=IPF&cntry=US&draw=2&rank=36

    • #26054
      Geoff
      Participant

      Thanks Char.  I have visited Toronto twice over the years. Many many similarities to our way of life in Oz. Loved it. The top for me in Canada has to be Quebec Once only visit for a week, but, ooh la la.  Probably because we lived in UK for about 12 years and had many holidays in Europe where the history etc entranced me. Have been back most years.

      Getting a bit sick of THE Election. We get blanket coverage here. aaghhhhhhh.

      Best wishes

      Geoff.

    • #26055

      Hi Geoff,

      Yes, I agree with you and felt many similarities between life in Toronto and Sydney, in particular but between Canada and Australia in general. I love Oz and can’t wait to go back! Quebec is beautiful, I went to Quebec City last year for a conference and loved the old architecture and stunning views into the mountains. Beautiful spot! Have you ever done western Canada, like Alberta or BC? Also a fave spot of mine, but of course I am bias 🙂 I loved visiting SA (Adelaide), Vic (Melbourne and area, including Yarra Valley, Croydon, Fingal/Peninsula area, etc) and NSW including Sydney, and all around the north shore trails, up the Blue Mountains. It was just amazing!

      Enjoy your weekend.
      Char.

    • #26059

      Thanks so much for this information @pbesio! I have no doubt others will find this informative and helpful. It was 1 year ago today that I flew to Texas for the PFF Summit and had the chance to talk to the team at Galapagos, as they were there in the vendor displays. Hard to believe, how the world has changed in just one year… stay well!
      Char.

    • #26060

      I’m so glad you’re finding the site helpful Richard! Thanks for sharing, and giving us an update on the trial. Pete also mentioned he has another 52 weeks on the trial, based on the “arm” of the study he’s in and Galapagos just enrolling the 750th (and last) patient in that trial to start the meds. I’m really hoping this study yields some hopeful results for all of us! Thanks for sharing your experience, and I’m glad to hear things are going pretty well for you with it. Stay well!
      Char.

    • #26066

      Thanks so much for sharing Bill, I’m so glad you’re comfortable with the protocols Yale has put in place amid the pandemic. That is really reassuring, I agree. I’ll keep my fingers crossed that the experience you’re having with the trial continues to go well, and that recruitment/enrolling continues! Thanks for writing, Char

    • #26068

      You’re too kind @richardsc! @mark-koziol and I feel so privileged to be moderators on this site, and interact with some many helpful, courageous and kind individuals willing to help one another through this cruel disease. What a day we’ll all have celebrating when a cure is found for this disease! Hugs to you 🙂

    • #26069
      Mark Koziol
      Keymaster

      Thank you Carol for your kind words. I’m sorry I didn’t respond sooner. I’ve been sort of out of commission. Looking to get back into the swing of things this coming week. Charlene thank you for being an excellent mentor and guiding me in this endeavor. Mark

    • #26078
      Carol Richards
      Participant

      Believe me, I am not too kind.  You are both priceless!  Thank you for responding.  Take care!

       

    • #26100

      ♥ ♥ ♥

      you too Carol! Stay safe!
      Char.

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