Flag of the European Union

EU Clinical Trials Register

Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:

interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC

clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).

The EU Clinical Trials Register currently displays 43871 clinical trials with a EudraCT protocol, of which 7290 are clinical trials conducted with subjects less than 18 years old. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).

Examples: Cancer AND drug name. Pneumonia AND sponsor name.
How to search [pdf]

Advanced Search:

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

< Back to search results

Clinical Trial Results:
A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Study to Assess the Safety and Efficacy of Three Doses of Clobetasol Propionate when Administered Intra-orally Twice Daily in Patients with Oral Lichen Planus (OLP) using Rivelin®-CLO patches

Summary
EudraCT number	2017-002193-40
Trial protocol	IE DK GB
Global end of trial date	20 Dec 2019

Results information
Results version number	v1(current)
This version publication date	11 Nov 2021
First version publication date	11 Nov 2021
Other versions
Summary report(s)	Full CSR CSR Summary

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

DT-001-R-004

ISRCTN number

-

US NCT number

-

WHO universal trial number (UTN)

-

Sponsor organisation name

Afyx Therapeutics A/S

Sponsor organisation address

Lergravsvej 57, 2. tv, København S, Denmark,

Public contact

Lars Siim Madsen, PhD, Afyx Therapeutics A/S, +45 51912315, lsm@afyxtx.com

Scientific contact

Lars Siim Madsen, PhD, Afyx Therapeutics A/S, +45 51912315, lsm@afyxtx.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

12 Mar 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

20 Dec 2019

Global end of trial reached?

Yes

Global end of trial date

20 Dec 2019

Was the trial ended prematurely?

No

Main objective of the trial

To demonstrate the efficacy of three different doses of Rivelin®-CLO patches in treating OLP lesions over 4 weeks of treatment assessed by change in ulcer area.

Protection of trial subjects

While patients were encouraged to complete the study, they had the right to discontinue from IMP or completely withdraw from the study at any time and for any reason without disclosing why and without having disadvantages. A genuine effort had to be made to determine the reason(s) why patient decided to discontinue IMP treatment or withdraw from the study, whenever possible.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

01 May 2018

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 27

Country: Number of subjects enrolled

Denmark: 14

Country: Number of subjects enrolled

Germany: 6

Country: Number of subjects enrolled

Ireland: 10

Country: Number of subjects enrolled

Canada: 29

Country: Number of subjects enrolled

United States: 52

Worldwide total number of subjects

138

EEA total number of subjects

30

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

82

From 65 to 84 years

56

85 years and over

0

Subject disposition

Top of page

Recruitment details

-

Screening details

After having provided written informed consent, the patients underwent screening procedures. This could include a study biopsy in case OLP had not been histologically confirmed in the past. At the end of the screening period, eligible patients were randomly assigned to one of the treatment groups on Day 0 (Visit 2/Baseline).

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Treatment Arm 1

Arm description

Rivelin®-CLO 1 μg/patch

Arm type

Experimental

Investigational medicinal product name

Rivelin®-CLO

Investigational medicinal product code

Other name

Clobetasol propionate

Pharmaceutical forms

Oromucosal patch

Routes of administration

Oral use, Topical

Dosage and administration details

1 μg/patch

Treatment Arm 2

Arm description

Rivelin®-CLO 5 μg/patch

Arm type

Experimental

Investigational medicinal product name

Rivelin®-CLO

Investigational medicinal product code

Other name

Pharmaceutical forms

Oromucosal patch

Routes of administration

Oral use, Topical

Dosage and administration details

5 μg/patch

Treatment Arm 3

Arm description

Rivelin®-CLO 20 μg/patch

Arm type

Experimental

Investigational medicinal product name

Rivelin®-CLO

Investigational medicinal product code

Other name

Pharmaceutical forms

Oromucosal patch

Routes of administration

Oral use, Topical

Dosage and administration details

20 μg/patch

Placebo

Arm description

Rivelin® plain patch (Placebo)

Arm type

Placebo

Investigational medicinal product name

Rivelin®-CLO 1

Investigational medicinal product code

Other name

Pharmaceutical forms

Oromucosal patch

Routes of administration

Oral use, Topical

Dosage and administration details

0 μg/patch (placebo)

Number of subjects in period 1	Treatment Arm 1	Treatment Arm 2	Treatment Arm 3	Placebo
Started	40	34	33	31
Completed	34	33	30	25
Not completed	6	1	3	6
Consent withdrawn by subject	1	-	2	2
Adverse event, non-fatal	2	-	-	2
Other reason	1	-	-	-
Lost to follow-up	1	-	-	-
Lack of efficacy	1	1	-	2
Protocol deviation	-	-	1	-

Baseline characteristics

Top of page

Reporting group title

Treatment Arm 1

Reporting group description

Rivelin®-CLO 1 μg/patch

Reporting group title

Treatment Arm 2

Reporting group description

Rivelin®-CLO 5 μg/patch

Reporting group title

Treatment Arm 3

Reporting group description

Rivelin®-CLO 20 μg/patch

Reporting group title

Placebo

Reporting group description

Rivelin® plain patch (Placebo)

Reporting group values	Treatment Arm 1	Treatment Arm 2	Treatment Arm 3	Placebo	Total
Number of subjects	40	34	33	31	138
Age categorical
Units: Subjects
In utero					0
Preterm newborn infants (gestational age < 37 wks)					0
Newborns (0-27 days)					0
Infants and toddlers (28 days-23 months)					0
Children (2-11 years)					0
Adolescents (12-17 years)					0
Adults (18-64 years)					0
From 65-84 years					0
85 years and over					0
Age continuous
Units: years
median (full range (min-max))	63 (19 to 89)	61 (37 to 75)	60 (33 to 77)	66 (30 to 81)	-
Gender categorical
Units: Subjects
Female	28	21	24	26	99
Male	12	13	9	5	39
Race
Units: Subjects
White	36	32	26	29	123
Black or afro-am.	2	0	1	1	4
Asian	2	1	4	1	8
Native American	0	1	0	0	1
Other	0	0	2	0	2

End points

Top of page

Reporting group title

Treatment Arm 1

Reporting group description

Rivelin®-CLO 1 μg/patch

Reporting group title

Treatment Arm 2

Reporting group description

Rivelin®-CLO 5 μg/patch

Reporting group title

Treatment Arm 3

Reporting group description

Rivelin®-CLO 20 μg/patch

Reporting group title

Placebo

Reporting group description

Rivelin® plain patch (Placebo)

Primary: Primary Efficacy Endpoint

Top of page

End point title

Primary Efficacy Endpoint

End point description

End point type

Primary

End point timeframe

Baseline to average of week 3 and 4.

End point values	Treatment Arm 1	Treatment Arm 2	Treatment Arm 3	Placebo
Number of subjects analysed	40	34	33	31
Units: Area (cm^2)
number (confidence interval 95%)
Week 3-4	-0.19 (-0.61 to 0.22)	-0.51 (-0.95 to -0.07)	-0.45 (-0.89 to -0.01)	0.06 (-0.38 to 0.50)

Analysis of ulcer size (cm^2), ANCOVA, FAS

Comparison groups

Treatment Arm 1 v Treatment Arm 2 v Treatment Arm 3 v Placebo

Number of subjects included in analysis

138

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0468 ^[1]

Method

ANCOVA

Parameter type

Mean difference (final values)

Point estimate

-0.45

Confidence interval

level

95%

sides

2-sided

lower limit

-0.89

upper limit

-0.01

Variability estimate

Standard deviation

Dispersion value

0.87

Notes
[1] - Significance level changed to 0.049 (adjusted for interim analysis) 5 mcg to placebo, p value = 0.0226 1 mcg vs placebo, p value = 0.3579

Adverse events

Top of page

Timeframe for reporting adverse events

For the safety analysis all AEs occurring from first trial-related activity performed until the end of the trial had been recorded and were coded and sorted by MedDRA-System Organ Class (SOC) and preferred terms (PT).

Adverse event reporting additional description

In the safety analysis all AEs in the Safety Set (N=138) are displayed by treatment group. Multiple occurrences of AEs related to a particular SOC or PT, respectively, in the same patient count as one occurrence.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.1

Reporting group title

Treatment Arm 1

Reporting group description

Rivelin®-CLO 1 μg/patch

Reporting group title

Treatment Arm 2

Reporting group description

Rivelin®-CLO 5 μg/patch

Reporting group title

Treatment Arm 3

Reporting group description

Rivelin®-CLO 20 μg/patch

Reporting group title

Placebo

Reporting group description

Rivelin® plain patch (Placebo)

Serious adverse events	Treatment Arm 1	Treatment Arm 2	Treatment Arm 3	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 40 (2.50%)	0 / 34 (0.00%)	1 / 33 (3.03%)	0 / 31 (0.00%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events		0	0	0
Injury, poisoning and procedural complications
Multiple fractures
subjects affected / exposed	1 / 40 (2.50%)	0 / 34 (0.00%)	0 / 33 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	0 / 40 (0.00%)	0 / 34 (0.00%)	1 / 33 (3.03%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Treatment Arm 1	Treatment Arm 2	Treatment Arm 3	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	4 / 40 (10.00%)	4 / 34 (11.76%)	4 / 33 (12.12%)	5 / 31 (16.13%)
Gastrointestinal disorders
Periodontal disease
subjects affected / exposed	2 / 40 (5.00%)	2 / 34 (5.88%)	4 / 33 (12.12%)	2 / 31 (6.45%)
occurrences all number	2	2	4	2
Infections and infestations
Nasopharyngitis
subjects affected / exposed	2 / 40 (5.00%)	2 / 34 (5.88%)	0 / 33 (0.00%)	3 / 31 (9.68%)
occurrences all number	2	2	0	3

More information

Top of page

Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

For support, Contact us.

The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

European Medicines Agency © 1995-Fri May 03 12:25:15 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands