Tagged: cost, financial assistance, Galapagos, IPF, lung disease, PF, results
- This topic has 45 replies, 20 voices, and was last updated 2 years, 1 month ago by Pete Besio.
October 22, 2020 at 12:03 pm #25879
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:
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.
October 22, 2020 at 2:48 pm #25885Donald Salzberg MDParticipant
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
October 29, 2020 at 3:10 pm #25962Allan ByronParticipant
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?
December 4, 2020 at 12:04 pm #26342Douglas k FreemanParticipant
how will this affect your progression of the disease if you are receiving a placebo? I live in Florida and I’m trying to get help paying for Esbtiet it is 1080.00 a script per month the insurance copay that I cannot afford needs help with some guidance. I don’t know what to do because my disease is progressing quickly. I’m scared I don’t want to hurt myself by raking something that may not even be a medication. Please help!
December 4, 2020 at 4:10 pm #26346
Thats a good question, Douglas! I’m not in the trial, so I wouldn’t have had an opportunity to ask it but I wonder if you have, @pbesio? I don’t imagine a placebo would cause your disease to progress any faster, but I can’t confirm/deny that with any certainty. Regarding Esbriet, have you tried any compassionate care grants or called Genentech to inquire about any patient support options they have for finances? I’m not on Esbriet, so I’m not sure of any but Genentech’s website is a good place to start 🙂
December 5, 2020 at 2:59 pm #26352
I feel your pain on the Esbriet expense, my copay is about half yours and it stings for sure. Regarding the Galapegos study, the clinic that I am attending seems to feel that the study medication is having a positive effect on participants. I am not an expert on placebos, but i think by definition a placebo should have no effect on you, either positive or negative. What part of FL are you in? If you are near Clearwater, you can call St. Francis at 727-210-4606. I believe their phone tree includes an option for clinical trials, select that. Odds are you will need to leave a message, but they have always been prompt in getting back to me. The trial allows me to have nearly monthly contact with Dr Averill. I believe he knows IPF very well. If you are not sucessful in getting enrolled in the study, I might suggest scheduling an appointment with him anyway, he would provide you with a great second opinion. I will send you a direct message also, feel free to return it, happy to do what I can to help you.
March 20, 2021 at 3:43 am #27807RonParticipant
Need help paying for Esbriet (pirfenidone) or Ofev (nintedanib)? Consider contacting Healthwell Foundation http://www.healthwellfoundation.org. Perhaps you are like me. My Social Security payout disqualified me for any state or federal assistance. If your insurance plan (Medicare, private insurance, etc.) doesn’t cover all of your drug costs then Healthwell may come to the rescue.
Healthwell paid 100% of my drug expense beyond what was covered in my Medicare Advantage plan. They provided a grant which would cover my drug expense for a year. The foundation administered the grant so I didn’t have to handle the money nor did I have any bill to pay. An added benefit: I quickly passed through the Medicare gap without paying a cent and into Medicare’s “Catastrophic” category. While in the catastrophic category until the end of the year I didn’t have to pay for any of my other drugs as well.
You can apply anytime throughout the year, and your grant will have you covered for a year. After that, you will have to reapply each year. Grants are subject to funds available. I was insured in a Kaiser Medicare Advantage program at the time and a Kaiser patient advocate set up a conference call between herself, me, and the Healthwell call taker. We were on the phone less than 10 minutes in the morning. Healthwell called back that same afternoon to tell me I was approved for the grant. It was a surprisingly simple and fast process.
I check the Healthwell website today 3/19/2021 and it states they are currently accepting applications for grants.
October 22, 2020 at 3:11 pm #25888Frank LoefflerParticipant
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.
October 22, 2020 at 6:11 pm #25898john sliwinskiParticipant
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.
October 26, 2020 at 10:48 am #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 🙂
October 27, 2020 at 3:12 pm #25918Wayne NelsonParticipant
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!
October 28, 2020 at 12:30 pm #25937
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!
October 28, 2020 at 12:34 pm #25941DennyParticipant
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…
October 28, 2020 at 8:47 pm #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!
October 29, 2020 at 2:51 pm #25961PeteParticipant
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.
October 29, 2020 at 4:48 pm #25964
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
October 29, 2020 at 6:15 pm #25968Jackie KalinaParticipant
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.
October 30, 2020 at 5:27 pm #25974Carol RichardsParticipant
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.
October 30, 2020 at 8:57 pm #25976
Sorry to hear that Pete! I know it can be so discouraging… hang in there!
October 30, 2020 at 9:00 pm #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.
October 30, 2020 at 9:10 pm #25981
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!
October 30, 2020 at 9:11 pm #25969Jofac O’HandlinParticipant
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!
November 1, 2020 at 2:10 pm #25993Allan ByronParticipant
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.
November 1, 2020 at 8:44 pm #25996
Thank you @abyron888 , much appreciated. Thanks in advance for sharing any information with us that you come across. Char.
November 3, 2020 at 6:34 pm #26006
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:
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.
November 4, 2020 at 7:28 pm #26014William KrackeParticipant
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.
November 5, 2020 at 5:20 pm #26035
>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.
November 5, 2020 at 5:56 pm #26038
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.
November 5, 2020 at 6:09 pm #26037GeoffParticipant
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.
November 6, 2020 at 12:45 pm #26046
Thanks @pbesio, that would be great. We appreciate your efforts on this!
November 6, 2020 at 12:51 pm #26048
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! 🙂
November 6, 2020 at 3:23 pm #26049
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:
November 6, 2020 at 5:39 pm #26054GeoffParticipant
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.
November 7, 2020 at 9:54 am #26055
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.
November 7, 2020 at 10:03 am #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!
November 7, 2020 at 10:05 am #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!
November 7, 2020 at 10:14 am #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
November 7, 2020 at 10:44 am #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 🙂
November 7, 2020 at 11:18 am #26069Mark KoziolParticipant
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
November 8, 2020 at 5:30 pm #26078Carol RichardsParticipant
Believe me, I am not too kind. You are both priceless! Thank you for responding. Take care!
November 10, 2020 at 8:05 pm #26100
♥ ♥ ♥
you too Carol! Stay safe!
February 11, 2021 at 11:44 am #27230David SpaethParticipant
I got the word yesterday – GLPG1690-CL-304 trial has been discontinued, I’m to turn in all supplied medication and the diary.
February 11, 2021 at 11:48 am #27231
Yep, i got the same call. I will be meeting with my trials nurse on Monday, if I learn anything of value I will post it here.
February 11, 2021 at 1:03 pm #27232
I also got the call. Will meet with coordinator next week. She informed me
that a new study that started in January and they are recruiting new people
to join at this time. There will only be 650 participants.The trial is in
the third phase. Google WA 42293 by Roche for information on the trial
February 11, 2021 at 3:03 pm #27240Suzanne R BrennanParticipant
I had been in this trial since May 2019. Yesterday trial participants were notified that the trial has been cancelled effective immediately. Not much yet in the way of details but hopefully we will get some explanation in the coming days as to why.
February 11, 2021 at 3:29 pm #27242
Google GLPG1690 Clinical Trial this will tell you why the
Trial was cancelled.
February 11, 2021 at 5:59 pm #27250RandyParticipant
Hello Charlene and everyone on the blog today. If you remember, I have told you about my experience this past year. It will be 1 years come March that I was diagnosed with IPF. I am not taking the 2 approved drugs because from everything I have read here and thru other studies. I don’t need the side effect along with the other problems I have with my heart. But I have been doing a lot of studying on all the drugs are being tested. GLPG1690 was one that should good results and none of the side effects. It was suppose to be ready this years. Is that still on schedule or has it been moved back? There are over 20 drugs in tests and now that more money is being put forth, more are being tested. I hope they have one of those soon as I would like to live a little longer. Do you remember the lady who was going to get into a test and write me about the drug to see what I knew? She never did. Hope she is doing good. Well, that is my thoughts for tonight. Everyone have a good evening and stay safe.
February 12, 2021 at 6:30 am #27251
See the messages above. I was a participant in GLPG 1690, as were a number of forum members. It has been cancelled. Some info here:
Galapagos and Gilead Discontinue ISABELA Phase 3 Trials in IPF | Business Wire
I have my exit screening scheduled for Monday, I will post if I learn anything.
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