A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis

• Sponsor: Sublimity Therapeutics Holdco Limited (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03844932
• Collaborator: Dr. Falk Pharma GmbH (Industry)
• Enrollment: 235
• Locations: 89
• Arms: 4
• Actual Duration (Months): 26.6
• Patients Per Site: 2.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on the 3-Component Adapted Mayo Score (comprised of rectal bleeding, stool frequency and endoscopy sub-scores; score range 0-9).

Condition or Disease	Intervention/Treatment	Phase
Colitis, Ulcerative	Drug: ST-0529	Phase 2

Detailed Description

The study consists of a Screening period, Treatment period and Follow-up. The Screening period is comprised of two separate in-clinic visits, SV1 and SV2. At the initial Screening visit (SV1), subjects will be required to provide written informed consent to participate in the study and will then be assessed for eligibility. Electronic diaries will be provided to subjects at this visit to use for the duration of the study in order to record information relating to their UC disease. Subjects will return to the clinic for their Screening endoscopic assessment (SV2). Ulcerative colitis disease activity for eligibility will be assessed using the 3-Component Adapted Mayo Score. Upon successful completion of the Screening period, subjects will return to the clinic for their Baseline visit.

During the Treatment period, subjects will be evaluated in the clinic at Baseline (Day 1), Week 2, Week 4, Week 8, and Week 12 (End of Treatment Period). At Week 6 and Week 10, subjects will be contacted by telephone to assess Adverse Events (AEs), concomitant medication usage and study drug regimen adherence.

Subjects who complete the 12-week Treatment period will attend the Week 16 End of Study (EOS) visit. Subjects who discontinue study drug and withdraw or are withdrawn from the study before the Week 12 visit will be requested to return to the clinic as soon as possible to complete an Early Termination (ET) visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 235 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The study will investigate ST-0529 doses of 18.75 mg BID, 37.5 mg BID, or 75 mg BID, versus matching placebo BID.The study will investigate ST-0529 doses of 18.75 mg BID, 37.5 mg BID, or 75 mg BID, versus matching placebo BID.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: The study will be conducted as a double-blind study. Both the Investigator and subjects will be blinded with respect to the treatment the subject will receive. In addition, the central reader of the endoscopy assessment will be blinded to subject treatment for the entire study.
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis
• Actual Study Start Date: Jan 24, 2019
• Actual Primary Completion Date: Apr 14, 2021
• Actual Study Completion Date: Apr 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ST-0529 18.75 mg* ST-0529: 18.75 mg orally twice daily (BID) *Jan 2021 update: following the IDMC recommendation, this arm has been dropped	Drug: ST-0529; ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.; Other Names: cyclosporine
Experimental: ST-0529 37.5 mg* ST-0529: 37.5 mg orally twice daily (BID) *Jan 2021 update: following the IDMC recommendation, this arm has been dropped	Drug: ST-0529; ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.; Other Names: cyclosporine
Experimental: ST-0529 75 mg ST-0529: 75 mg orally twice daily (BID)	Drug: ST-0529; ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.; Other Names: cyclosporine
Placebo Comparator: Matching Placebo Placebo: matching placebo orally twice daily (BID)	Drug: ST-0529; ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.; Other Names: cyclosporine

Outcome Measures

Primary Outcome Measures

1. Clinical Remission at Week 12 [Week 12]

   Stool frequency sub-score of ≤ 1 associated with a decrease ≥ 1 point from baseline, rectal bleeding sub-score of 0, and an endoscopic sub-score of ≤ 1 using the 3-Component Adapted Mayo Score. The 3-Component Adapted Mayo Score is a measure of UC disease ranging from 0 to 9 points and consists of 3 sub-scores, each graded from 0 - 3 with higher scores indicating more severe disease. The sub-scores are stool frequency (0 - 3); rectal bleeding (0 - 3); findings of endoscopy (0 - 3).

Secondary Outcome Measures

1. Clinical Response at Week 12 [Week 12]

   A decrease from baseline in the 3-Component Adapted Mayo Score of ≥ 2 points and ≥ 30%, with an accompanying decrease in the sub-score for rectal bleeding of ≥ 1 point or an absolute sub-score for rectal bleeding of ≤ 1. The 3-Component Adapted Mayo Score is a measure of UC disease ranging from 0 to 9 points and consists of 3 sub-scores, each graded from 0 - 3 with higher scores indicating more severe disease. The sub-scores are stool frequency (0 - 3); rectal bleeding (0 - 3); findings of endoscopy (0 - 3).

2. Endoscopic Healing at Week 12 [Week 12]

   Endoscopic Healing (I) defined as an endoscopic sub-score of ≤ 1. The endoscopic sub-score is part of the 3-Component Adapted Mayo score and ranges from 0 - 3, with higher scores indicating more severe disease.

3. Corticosteroid-free clinical response at Week 12 [Week 12]

   Clinical response and achieving a corticosteroid-free status at Week 12 in subjects using oral corticosteroids at the Baseline visit. Clinical response is defined as a decrease from baseline in the 3-Component Adapted Mayo Score of ≥ 2 points and > 30%, with an accompanying decrease in the sub-score for rectal bleeding of ≥ 1 point or an absolute sub-score for rectal bleeding of ≤ 1.

4. Corticosteroid-free clinical remission at Week 12 [Week 12]

   Clinical remission and achieving a corticosteroid-free status at Week 12 in subjects using oral corticosteroids at the Baseline visit. Clinical remission is defined as a stool frequency sub-score of ≤ 1 associated with a decrease ≥ 1 point from baseline, rectal bleeding sub-score of 0, and an endoscopic sub-score of ≤ 1 using the 3-Component Adapted Mayo Score.

5. Changes from baseline in individual Adapted Mayo sub-scores at Week 12 [Week 12]

   The Adapted Mayo Score is a measure of UC disease ranging from 0 to 12 points and consists of 4 sub-scores, each graded from 0 - 3 with higher scores indicating more severe disease. The sub-scores are stool frequency (0 - 3); rectal bleeding (0 - 3); findings of endoscopy (0 - 3); and Physician's Global Assessment [PGA] (0 - 3).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male and female adult subjects 18 to 75 years old, inclusive.

2. Willing to provide written informed consent and to be compliant with the schedule of study visits and protocol assessments.

3. Diagnosis of UC established at least 3 months prior to the Baseline visit, by clinical and endoscopic evidence (colonoscopy or flexible sigmoidoscopy)

4. Moderately to severely active UC defined as the 3-Component Adapted Mayo Score of 5-9, inclusive, with an endoscopic sub-score of ≥ 2 (from central reading), and a rectal bleeding sub-score of ≥ 1, as determined 10 days (± 3 days) prior to Baseline.

5. Evidence of active UC, confirmed histologically (from local read), extending proximal to the rectum with ≥ 15 cm of involved colon.

6. At Screening, a colonoscopy will be required if the subject has had extensive colitis or pancolitis of > 8 years duration or left-sided colitis of > 12 years duration but has not had a colonoscopy within 1 year of the initial screening date. If the subject has had a colonoscopy within 1 year of the initial screening date, a flexible sigmoidoscopy may be used.

7. Subjects presenting at Screening with moderately to severely active UC demonstrating an inadequate response or loss of response or intolerance/medical contraindication to at least one of the following conventional therapies for UC:

1. Corticosteroids:

2. Signs and symptoms of active disease despite treatment with an adequate dose (e.g., prednisolone > 40 mg/day or equivalent) over a period of 4 weeks for oral therapy or intravenously (IV) for up to 1 week or ≥ 9 mg/day oral budesonide;

OR

1. Unable to reduce corticosteroids below the equivalent of prednisolone 10 mg daily orally within 3 months of starting steroids or having experienced a relapse within 3 months of stopping steroids;

OR

1. History of, or current intolerance to corticosteroids (including, but not limited to Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection).

1. Immunomodulators:

2. Signs and symptoms of active disease despite at least 3 months of treatment with a sufficient dose (oral azathioprine ≥ 1.5 mg/kg or 6-mercaptopurine [6-MP] ≥ 0.75 mg/kg);

OR

1. History of, or current dose-limiting toxicity associated with use of the agent (e.g., but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test [LFT] abnormalities, lymphopenia, TPMT genetic mutation, infection).

1. Anti-tumor necrosis factor (anti-TNF) agents:

2. Signs and symptoms of active disease despite treatment with a single anti-TNF agent. Treatment failure is defined as a relapse after an initial response to therapy as follows:

• Infliximab: At least 4 infusions of at least 5 mg/kg within a 14-week timeframe for induction and maintenance;

• Adalimumab: Induction regimen incorporating 160 mg at Week 0 (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) and 80 mg at Week 2, followed by maintenance treatment of 40 mg every other week up to at least Week 8;

• Golimumab: Induction regimen incorporating 200 mg subcutaneous (sc) injection at Week 0, followed by 100 mg at Week 2 and then maintenance treatment of 50 mg or 100 mg (weight dependent) every 4 weeks after completion of the induction regimen up to at least Week 12;

OR

1. History of, or current intolerance (with an initial response), defined as the presence of clinically significant side-effects, including infusion-related hypersensitivity.

1. Vedolizumab:

2. Signs and symptoms of active disease despite a history of at least one induction regimen, defined as at least a 14-week (10 weeks in the EU) induction consisting of 300 mg IV at Weeks 0, 2 and 6.

OR

1. History of intolerance to vedolizumab including, but not limited to, serious infections, hepatotoxicity, heart failure, allergic reactions, or any other condition that contributed to discontinuation of the agent.

1. Subjects receiving oral corticosteroids for the treatment of UC must be on a stable dose of ≤ 40 mg/day (prednisolone or equivalent), or ≤ 9 mg/day budesonide. This dose must be stable from the initial Screening visit until 1 week after the initiation of study treatment.

2. Subjects receiving oral 5-ASA must be on a stable dose from the initial Screening visit until the end of the study.

3. Subjects willing to cease the use of any therapeutic enema or suppository or foams, other than that required in preparation for study-mandated colonoscopy/flexible sigmoidoscopies, from the initial Screening visit until the end of the study.

4. Subjects willing to cease use of azathioprine or 6-MP from the initial Screening visit until the end of the study.

5. Negative serum pregnancy test in females of childbearing potential at Screening.

6. If female and of childbearing potential, must agree to be sexually abstinent or use one of the following highly effective methods of birth control from the initial

Screening visit until 30 days after the last dose of study drug is administered:

1. Hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants);

2. Intrauterine contraceptive system;

3. Surgical sterilization or partner sterile (must have documented proof);

AND

One of the following effective methods of birth control:

1. Male/female condom;

2. Cervical cap with spermicide;

3. Diaphragm with spermicide;

4. Contraceptive sponge.

5. Male subjects must be either surgically sterile (must have documented proof), agree to be sexually inactive or use a double-barrier method of birth control (e.g., condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration until 90 days after final drug administration.

Exclusion Criteria:

If a subject has any of the following criteria, they will be excluded from the study:

1. Subjects without previous treatment for UC.

2. Ulcerative colitis limited to rectum (ulcerative proctitis).

3. Evidence of acute severe colitis with toxic megacolon, abdominal abscess, bowel stricture or bowel perforation.

4. A diagnosis of Crohn's colitis, colitis yet to be classified, ischemic colitis, NSAID-induced colitis, idiopathic colitis (i.e., colitis not consistent with UC) or radiation colitis.

5. Subjects with evidence of pathogenic bowel infection (Clostridium difficile, Escherichia coli, Salmonella, Shigella or Campylobacter).

6. Previous surgery for UC or, in the opinion of the Investigator, will likely require surgery for UC during the study.

7. Any histological evidence of mucosal dysplasia.

8. Subjects with a current or recent history of severe, progressive or uncontrolled cardiac (including uncontrolled hypertension), renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological (e.g., history of seizures) disease, abnormal magnesium or potassium levels, hypocholesterolemia, or any other severe co-morbidity that, in the opinion of the Investigator, could confound the study results or put the study subject at unreasonable risk.

9. Malignancies or history of malignancy within 5 years of the initial Screening visit, with the exception of adequately treated or excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.

10. Any of the following laboratory abnormalities during the screening period - if values are initially outside the prescribed limits, the evaluation may be repeated once within the screening period to determine eligibility:

11. Hemoglobin level < 8.0 g/dL

12. Absolute WBC count < 3.0 × 10^9/L

13. Absolute Lymphocyte count < 0.5 × 10^9/L

14. Absolute neutrophil count < 1.2 × 10^9/L

15. Platelet count < 100 × 10^{9/L or >1200 × 10}9/L

16. ALT or AST > 2.0 × ULN

17. Alkaline phosphatase > 2.0 × ULN

18. Serum creatinine > 1.5 × ULN

19. Bilirubin > 1.5 × ULN

20. Subjects with active TB infection or known history of prior treated or untreated TB infection.

21. Subject with a positive serology test result for HIV (HIV type 1 or type 2).

22. Subject with a positive serology test result for active HBV or HCV infection.

23. Treatment with biologic agents for UC within 56 days or 5 half-lives (whichever is greater) prior to the Baseline visit.

24. Treatment with any calcineurin inhibitor (e.g. cyclosporine or tacrolimus) within 28 days prior to the Baseline visit.

25. Treatment with methotrexate or JAK inhibitors (e.g. tofacitinib) from the initial Screening visit until the end of the study.

26. Initiation of treatment with an oral or IV corticosteroid from the initial Screening visit until the end of the study.

27. Use of any strong inhibitors of CYP enzymes (e.g., cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, grapefruit juice and HIV antivirals) within 14 days prior to the Baseline visit.

28. Use of strong or moderate P-gp inhibitors (e.g., amiodarone, azithromycin, clarithromycin, itraconazole, ketoconazole, dronedarone, lapatinib, quinidine, ranolazine, verapamil) within 14 days prior to the Baseline visit.

29. Use of any herbal medication for the treatment of UC or which might interfere with CYP enzymes within 14 days prior to the Baseline visit.

30. Subjects vaccinated with a live or live-attenuated vaccine within 14 days of the Baseline visit, or planned vaccination during conduct of the study.

31. Subjects with a QTcF of > 450 ms for males and > 470 ms for females at Screening.

32. A history of risk factors for Torsades de pointes (e.g., history of heart failure, hypokalemia, family history of Long QT Syndrome).

33. Known hypersensitivity to cyclosporine or any excipients contained in ST-0529.

34. History of alcohol or drug abuse in the year prior to the initial Screening visit.

35. Subjects currently breast feeding, pregnant, or unwilling to delay initiation of breast feeding for at least 90 days after the last dose of study drug is administered.

36. Participation in another clinical trial and having received investigational medication within 30 days or within 5 half-lives (whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial.

37. Subjects who, in the opinion of the Investigator, are unsuitable for inclusion in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palmtree Clinical Research Inc	Palm Springs	California	United States	92262
2	Advanced Research Institute	Largo	Florida	United States	33377
3	Advanced Research Institute, Inc.	New Port Richey	Florida	United States	34653
4	Endoscopic Research Inc	Orlando	Florida	United States	32803
5	University of Chicago	Chicago	Illinois	United States	60637
6	AGA Clinical Reasearch Associates, LLC	Egg Harbor Township	New Jersey	United States	08234
7	Baylor College of Medicine	Houston	Texas	United States	77030
8	Biopharma Informatic, LLC.	Houston	Texas	United States	77084
9	Gomel Regional Clinical Hospital	Gomel		Belarus	246 029
10	Grodno Regional Clinical Hospital	Grodno		Belarus	230017
11	City Clinical Emergency Hospital	Minsk		Belarus	220024
12	MedConsult Pleven	Pleven		Bulgaria	5800
13	Medical Center Asklepion	Sofia		Bulgaria	1303
14	UMBAL Tsaritsa Joanna ISUL	Sofia		Bulgaria	1527
15	Dalhousie University - Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 2Y9
16	London Health Sciences Centre	London	Ontario	Canada	N6A 5W9
17	CHU Amiens Picardie - Service Hépato-Gastroentérologie	Amiens		France	80054
18	CHU DE MONTPELLIER - Hôpital St ELOI	Montpellier		France	34295
19	CHU de Saint-Etienne - Service de Gastro-Entérologie-Hépatologie	Saint-Étienne		France	42055
20	Hôpital de Brabois Service d'Hépato-Gastro-Entérologie	Vandœuvre-lès-Nancy		France	54511
21	Eugastro GmbH	Leipzig	Saxony	Germany	4103
22	Medizinische Klinik für Gastroenterologie, Infektiologie, Rheumatologie charite	Berlin		Germany	12203
23	Krankenhaus Walfriede, Akademisches Lehrkrankenhaus der Charite	Berlin		Germany	14163
24	Agaplesion Markus Krankenhaus Medizinischen Klinik I, Gastroenterologie, Hepatologie, Onkologie, lnfektiologie	Frankfurt		Germany	60431
25	Universitatsklinikum Freiburg, Medizinische Klinik	Freiburg		Germany	79106
26	Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Zentrym für Innere Medizin	Hannover		Germany	30625
27	Klinik für Gastroenterologie, Pulmologie und allg. lnnere Medizin	Köln		Germany	5103
28	Universität Leipzig, Klinik f. Gastroenterologie und Rheumatologie	Leipzig		Germany	4103
29	Gastroenterologische Gemeinschaftspraxis Minden	Minden		Germany	32123
30	DRC Gyógyszervizsgáló Központ Kft.	Balatonfüred		Hungary	8230
31	Semmelweis University	Budapest		Hungary	1088
32	Semmelweis University, AOK Varosmajori Sziv- es Ergyogyaszati Klinika,	Budapest		Hungary	H-1031
33	Bugat Pal Hospital	Gyongyos		Hungary	3200
34	Mater Misericordiae University Hospital	Dublin		Ireland	D07 RX49
35	St. James's Hospital	Dublin		Ireland
36	Gastroenterology Institute, Emek Medical Center	Afula		Israel	1834111
37	Barzilai Medical Center	Ashkelon		Israel	7830604
38	Clalit Health Services Jerusalem	Jerusalem		Israel	9362410
39	Institute of Gastroenterology, Meir Medical Center	Kfar Saba		Israel	4428164
40	Humanitas Research Hospital, IBD Center	Milan		Italy	20089
41	A.0.U. di Modena - Policlinico S.C. di Gastroenterologia	Modena		Italy	41124
42	Fondazione IRCCS Policlinico San Matteo - Medicina Generale I	Pavia		Italy	27100
43	ASST Rhodense - Ospedale di Rho	Rho		Italy	20017
44	Fondazione Casa Sollievo della Sofferenza	San Giovanni Rotondo		Italy	71013
45	Centrum Opieki Zdrowotnej Orkan-med	Ksawerów		Poland	95-054
46	Medicome Sp. z o.o.	Oświęcim		Poland	32600
47	Centrum Medyczne Medyk	Rzeszów		Poland	35-526
48	Endoskopia sp. z o.o.	Sopot		Poland	81-756
49	WIP Warsaw IBD Point Profesor Kierkus	Warszawa		Poland	00-728
50	Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego UM	Łódź		Poland	90-153
51	MedLife Grivita	Bucharest		Romania	010719
52	Colentina Clinical Hospital	Bucharest		Romania	020125
53	University Hospital Bucharest	Bucharest		Romania	050098
54	Federal State Center of Coloproctology	Moscow		Russian Federation	123423
55	LLC Medical center Healthy family	Novosibirsk		Russian Federation	630099
56	Military Medical Academy	Saint Petersburg		Russian Federation	191 124
57	North-Western State Medical University n.a. I.I.Mechnikov	Saint Petersburg		Russian Federation	191015
58	Scientific Research Center Eco-Safety LLC	Saint Petersburg		Russian Federation	196143
59	Pavlov First Saint Petersburg State Medical University	Saint Petersburg		Russian Federation	197022
60	Saint-Petersburg State Medical Academy n.a. I.I. Mechnikov of Federal Agency of Healthcare & Social Development	Saint-Petersburg		Russian Federation	195067
61	Non state Public Health Institution "Railway clinical hospital on station Samara" of joint stock company Russian railways	Samara		Russian Federation	403029
62	Saratov State Medical University	Saratov		Russian Federation	410054
63	Siberia State Medical University	Tomsk		Russian Federation	630055
64	Clinical Center Zvezdara	Belgrade		Serbia	11000
65	Clinical-Hospital Centre Bezanijska Kosa - Gastroenterology Department	Belgrade		Serbia	11080
66	Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"	Belgrad		Serbia	11000
67	Clinical Center Kragujevac	Kragujevac		Serbia	34000
68	Hospital Universitario Virgen de la Macarena	Sevilla		Spain	41009
69	Chernivtsi Regional Clinical Hospital	Chernivtsi		Ukraine	58001
70	Ivano-Frankivsk National Medical University, Regional Clinical Hospital	Ivano-Frankivsk		Ukraine	76008
71	Kharkiv City Clinical Hospital No 2 n.a. prof. O.O.Shalimov	Kharkiv		Ukraine	61037
72	Kiev City Clinical Hospital No. 1	Kiev		Ukraine	2091
73	Communal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital"	Kyiv		Ukraine	04107
74	Ukrainian-German Gastroenterology Center "BYK-Kyiv"	Kyiv		Ukraine	1030
75	Volyn Regional Clinical Hospital	Lutsk		Ukraine	43000
76	Communal Nonprofit Enterprise "Lviv Clinical Emergency Care Hospital"	Lviv		Ukraine	79059
77	Communal Nonprofit Entreprise, "Lviv Clinical Emergency Care Hospital", 1st Therapeutic Dpt	Lviv		Ukraine	79059
78	Communal Nonprofit Enterprise "Odesa Regional Clinical Hospital"	Odesa		Ukraine	65025
79	Communal Nonprofit Enterprise "Ternopil University Hospital" of Ternopil Regional Council	Ternopil		Ukraine	46002
80	Municipal Institution "Uzhhorod Central District Hospital"	Uzhhorod		Ukraine	88009
81	Medical Center "Health Clinic"	Vinnytsia		Ukraine	21000
82	Communal Non-profit Enterprise "Vinnytsia City Clinical Hospital #1"	Vinnytsia		Ukraine	21029
83	Addenbrooke's Hospital	Cambridge	Cambridgeshire	United Kingdom	CB2 0QQ
84	South Eastern Health & Social Care Trust, Ulster Hospital	Belfast	Co Antrim	United Kingdom	BT161RH
85	Royal Liverpool & Broadgreen University Hospitals NHS Trust	Liverpool	Merseyside	United Kingdom	L7 8XP
86	Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust	Birmingham	Warwickshire	United Kingdom	B15 2TH
87	Barnsley Hospital NHS Foundation Trust	Barnsley	Yorkshire	United Kingdom	S75 2EP
88	University College London Hospital NHS Foundation Trust	London		United Kingdom	NWI 2BU
89	King's College Hospital NHS Foundation Trust	London		United Kingdom	SE59RS

Sponsors and Collaborators

• Sublimity Therapeutics Holdco Limited
• Dr. Falk Pharma GmbH

Investigators

• Study Director: Sponsor Responsible Medical Officer, Sublimity Therapeutics (HoldCo) Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sublimity Therapeutics Holdco Limited
• ClinicalTrials.gov Identifier: NCT03844932
• Other Study ID Numbers: CYC-202
• First Posted: Feb 19, 2019
• Last Update Posted: May 7, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer; Cyclosporine; Cyclosporins

Study Results

No Results Posted as of May 7, 2021