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Clinical Trial Results:
A randomized, investigator-and patient-blind, placebo controlled, parallel group first in human and proof of concept study to evaluate the safety, tolerability, and efficacy of CLL442 in patients with Cutaneous Squamous Cell Carcinoma in situ (SCCis)

Summary
EudraCT number	2017-003495-31
Trial protocol	BE
Global end of trial date	01 Nov 2018

Results information
Results version number	v1(current)
This version publication date	24 Oct 2019
First version publication date	24 Oct 2019
Other versions

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

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Trial information

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Sponsor protocol code

CCLL442X2201

ISRCTN number

US NCT number

NCT03333694

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Pharma AG

Sponsor organisation address

CH-4002, Basel, Switzerland,

Public contact

Clinical Disclosure Office, Novartis Pharmaceuticals AG, +41 61 324 1111,

Scientific contact

Clinical Disclosure Office, Novartis Pharmaceuticals AG, +41 61 324 1111,

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

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

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

Analysis stage

Final

Date of interim/final analysis

01 Nov 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

01 Nov 2018

Was the trial ended prematurely?

Main objective of the trial

- To assess the safety and tolerability of CLL442 in subjects with Cutaneous Squamous Cell Carcinoma in situ (SCCis) on both lesion free skin and SCCis lesions. - To evaluate the initial efficacy of CLL442 on reduction of lesion area in subjects with SCCis.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.

Background therapy

Evidence for comparator

Actual start date of recruitment

15 Dec 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 23

Country: Number of subjects enrolled

Australia: 12

Country: Number of subjects enrolled

Belgium: 5

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study was conducted in 8 centres across United States, Australia and Belgium.

Screening details

A total of 40 subjects were enrolled in the study, and all included in the Safety Population. The study consisted of two treatment periods; Treatment Period 1 (P1): CLL442 or placebo was applied on lesion free skin for 7 days. Treatment Period 2 (P2): CLL442 or placebo was applied on the target single SCCis lesion for a total of 84 days.

Period 1 title

Overall Study (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

CLL442 2.5 mg/g

Arm description

CLL442 cream 2.5 milligrams per gram (mg/g) was applied topically, twice daily for 7 days (during P1) on lesion free skin, followed by twice daily application on the target single Cutaneous Squamous Cell Carcinoma in situ (SCCis) lesion for up to 84 days (during P2).

Arm type

Experimental

Investigational medicinal product name

CLL442

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

CLL442 2.5 mg/g cutaneous cream application twice daily for 7 days on lesion free skin followed by application on target single SCCis lesion until visual clearance of the lesion and for an additional 14 days, or for a total of 84 days, whichever comes first.

Placebo

Arm description

CLL442-matching placebo cream was applied topically twice daily for 7 days (during P1) on lesion free skin, followed by twice daily application on the target single SCCis lesion for up to 84 days (during P2).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

CLL442-matching placebo cutaneous cream application twice daily for 7 days on lesion free skin followed by application on the target single SCCis lesion until visual clearance of the lesion and for an additional 14 days, or for a total of 84 days, whichever comes first.

Number of subjects in period 1	CLL442 2.5 mg/g	Placebo
Started	30	10
Completed	29	10
Not completed	1	0
Subject/Guardian Decision	1	-

Baseline characteristics

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Reporting group title

CLL442 2.5 mg/g

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group values	CLL442 2.5 mg/g	Placebo	Total
Number of subjects	30	10	40
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	72.3 ( 9.22 )	66.1 ( 8.60 )	-
Gender categorical
Units: Subjects
Female	17	4	21
Male	13	6	19

End points

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Reporting group title

CLL442 2.5 mg/g

Reporting group description

Reporting group title

Placebo

Reporting group description

Subject analysis set title

CLL442 2.5 mg/g (PK)

Subject analysis set type

Sub-group analysis

Subject analysis set description

The Pharmacokinetic (PK) analysis set included all subjects with at least one available valid (i.e., not flagged for exclusion) CLL442 concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.

Primary: Number of Subjects with Adverse Events (AEs), and Serious Adverse Events (SAEs)

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End point title

Number of Subjects with Adverse Events (AEs), and Serious Adverse Events (SAEs) ^[1]

End point description

An adverse event is any unfavourable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. An SAE is any AE which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalisation, etc. The safety analysis set included all subjects that received any study drug.

End point type

Primary

End point timeframe

From First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to Day 92 (End of Study (EOS))

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this end point.

End point values	CLL442 2.5 mg/g	Placebo
Number of subjects analysed	30	10
Units: subjects
AEs	20	4
SAEs	0	0

No statistical analyses for this end point

Primary: Number of Subjects with Local Tolerability Score at Day 7 or Day 84

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End point title

Number of Subjects with Local Tolerability Score at Day 7 or Day 84 ^[2]

End point description

Local tolerability or local skin reactions (LSRs) were assessed using visual, clinical, and tactile cues at each visit after first dosing and each parameter was scored 0-3 based on severity (none, mild, moderate and severe). Overall, 8 parameters were assessed which included: edema, erosion/ulceration, erythema, flaking/scaling/dryness, itching scabbing/dryness, vesicles and weeping/exudates. The safety analysis set included all subjects that received any study drug. "n" is the number of subjects with data available for analysis at the specific time point.

End point type

Primary

End point timeframe

Period 1 (P1) Day 1 (D1) to Day 92 (EOS)

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this end point.

End point values	CLL442 2.5 mg/g	Placebo
Number of subjects analysed	30	10
Units: subjects
Edema(P1, D1): Mild (n=30,10)	0	0
Edema(P1, D1): Moderate (n=30, 10)	0	0
Edema(P1, D1): Severe (n=30,10)	0	0
Edema(EOS): Mild (n=29,10)	5	0
Edema(EOS): Moderate (n=29,10)	1	1
Edema(EOS): Severe (n=29,10)	0	0
Erosion/Ulceration(P1, D1): Mild (n=30,10)	0	0
Erosion/Ulceration(P1, D1): Moderate (n=30,10)	0	0
Erosion/Ulceration(P1, D1): Severe (n=30,10)	0	0
Erosion/Ulceration(EOS): Mild (n=29,10)	2	1
Erosion/Ulceration(EOS): Moderate (n=29,10)	0	0
Erosion/Ulceration(EOS): Severe (n=29,10)	0	0
Erythema(P1, D1): Mild (n=30,10)	4	0
Erythema(P1, D1): Moderate (n=30,10)	0	0
Erythema(P1, D1): Severe (n=30,10)	0	0
Erythema(EOS): Mild (n=29,10)	12	3
Erythema(EOS): Moderate (n=29,10)	5	2
Erythema(EOS): Severe (n=29,10)	0	0
Flaking/Scaling/Dryness(P1, D1): Mild (n=30,10)	5	0
Flaking/Scaling/Dryness(P1, D1): Moderate (n=30,10	0	0
Flaking/Scaling/Dryness(P1, D1): Severe (n=30,10)	0	0
Flaking/Scaling/Dryness(EOS): Mild (n=29,10)	11	3
Flaking/Scaling/Dryness(EOS): Moderate (n=29,10)	4	1
Flaking/Scaling/Dryness(EOS): Severe (n=29,10)	0	0
Itching(P1, D1): Mild (n=30,10)	1	0
Itching(P1, D1): Moderate (n=30,10)	0	0
Itching(P1, D1): Severe (n=30,10)	0	0
Itching(EOS): Mild (n=29,10)	1	1
Itching(EOS): Moderate (n=29,10)	0	0
Itching(EOS): Severe (n=29,10)	1	0
Scrabbing/Dryness(P1, D1): Mild (n=30,10)	2	0
Scrabbing/Dryness(P1, D1): Moderate (n=30,10)	0	0
Scrabbing/Dryness(P1, D1): Severe (n=30,10)	0	0
Scrabbing/Dryness(EOS): Mild (n=29,10)	4	2
Scrabbing/Dryness(EOS): Moderate (n=29,10)	4	0
Scrabbing/Dryness(EOS): Severe (n=29,10)	0	0
Vesicles(P1, D1): Mild (n=30,10)	0	0
Vesicles(P1, D1): Moderate (n=30,10)	0	0
Vesicles(P1, D1): Severe (n=30,10)	0	0
Vesicles(EOS): Mild (n=29,10)	0	0
Vesicles(EOS): Moderate (n=29,10)	0	0
Vesicles(EOS): Severe (n=29,10)	0	0
Weeping/Exsudates(P1, D1): Mild (n=30,10)	0	0
Weeping/Exsudates(P1, D1): Moderate (n=30,10)	0	0
Weeping/Exsudates(P1, D1): Severe (n=30,10)	0	0
Weeping/Exsudates(EOS): Mild (n=29,10)	2	0
Weeping/Exsudates(EOS): Moderate (n=29,10)	0	0
Weeping/Exsudates(EOS): Severe (n=29,10)	0	0

No statistical analyses for this end point

Primary: Visual Analogue Scale (VAS) Score

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End point title

Visual Analogue Scale (VAS) Score ^[3]

End point description

Subjects were provided a diary to to assess the severity of pain (ranging from 0 = no pain at all to 10 = the worst imaginable pain) using a 10 cm VAS . The score (distance from left) on the VAS was recorded by the subject marking with a line. The safety analysis set included all subjects that received any study drug."n" is the number of subjects with data available for analysis at the specific time point.

End point type

Primary

End point timeframe

P1 Day 1 to Day 92 (EOS)

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this end point.

End point values	CLL442 2.5 mg/g	Placebo
Number of subjects analysed	30	10
Units: score on a scale
arithmetic mean (standard deviation)
P1 Day 1 (n=29,10)	1.9 ( 8.90 )	0.2 ( 0.63 )
P2 Day 84 (n=29,10)	0.2 ( 1.12 )	1.9 ( 4.68 )
EOS (n=29,10)	0.3 ( 1.04 )	1.0 ( 2.54 )

No statistical analyses for this end point

Primary: Change From Baseline in Lesion Area in Subjects with Squamous Cell Carcinoma in situ (SCCis) at Day 84

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End point title

Change From Baseline in Lesion Area in Subjects with Squamous Cell Carcinoma in situ (SCCis) at Day 84

End point description

Area is measured by pen and ruler and standardized digital photography. Lesion tracing (planimetry) were completed on clear paper to assess lesion area. Baseline for lesion area measurement was defined at Treatment Period 2, Day 1. The Pharmacodynamic (PD) analysis set included all subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.

End point type

Primary

End point timeframe

Period 2 Day 1 (Baseline) and Period 2 Day 84

End point values	CLL442 2.5 mg/g	Placebo
Number of subjects analysed	29	10
Units: square millimetre (mm^2)
arithmetic mean (confidence interval 90%)	-112.62 (-180.57 to 44.68)	-153.80 (-269.51 to 38.09)

CLL442 2.5 mg/g v Placebo

Comparison groups

CLL442 2.5 mg/g v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5984 ^[4]

Method

MMRM

Parameter type

Difference in means

Point estimate

41.18

Confidence interval

level

90%

sides

2-sided

lower limit

-93.02

upper limit

175.38

Notes
[4] - Change from baseline in lesion area was analyzed using a repeated measures mixed effects model (MMRM) which included effects for baseline lesion area, treatment, visit and treatment by visit interaction.

Secondary: Plasma Concentration of CLL442

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End point title

Plasma Concentration of CLL442

End point description

No pharmacokinetics (PK) analysis of the concentration-time data was performed as only 3% of the collected samples had CLL442 concentrations above Lower Limit of Quantification (LLOQ).

End point type

Secondary

End point timeframe

Day 1 through Day 84

End point values	CLL442 2.5 mg/g (PK)
Number of subjects analysed	0 ^[5]
Units: picograms per millilitre(pg/mL)
arithmetic mean (standard deviation)	( )

Notes
[5] - No PK analysis was done as only 3% of the collected samples had CLL442 concentrations above LLOQ.

No statistical analyses for this end point

Secondary: Time Required to Achieve 50% (Partial) Decrease in One Lesion Area

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End point title

Time Required to Achieve 50% (Partial) Decrease in One Lesion Area

End point description

Area is measured by pen and ruler and standardized digital photography. Lesion tracing (planimetry) were completed on clear paper to assess lesion area. The PD analysis set included all subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. 99999 indicates that the upper limit of 90% Confidence Interval was not estimable in placebo group.

End point type

Secondary

End point timeframe

Up to Day 84

End point values	CLL442 2.5 mg/g	Placebo
Number of subjects analysed	29	10
Units: days
median (confidence interval 90%)	57 (55.0 to 92.0)	55.5 (8.0 to 99999)

No statistical analyses for this end point

Secondary: Time Required to Achieve 10% (Partial) Decrease in One Lesion Area

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End point title

Time Required to Achieve 10% (Partial) Decrease in One Lesion Area

End point description

End point type

Secondary

End point timeframe

Up to Day 84

End point values	CLL442 2.5 mg/g	Placebo
Number of subjects analysed	29	10
Units: days
median (confidence interval 90%)	28.0 (8.0 to 31.0)	41.5 (8.0 to 57.0)

No statistical analyses for this end point

Secondary: Time Required to Achieve Complete (100%) SCCis One Lesion Clearance at the End of the Study

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End point title

Time Required to Achieve Complete (100%) SCCis One Lesion Clearance at the End of the Study

End point description

Area is measured by pen and ruler and standardized digital photography. Lesion tracing (planimetry) were completed on clear paper to assess lesion area.The PD analysis set included all subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. 99999 indicates that the median time and 90% Confidence Interval required to achieve complete lesion clearance was not estimable in both CLL442 and placebo groups.

End point type

Secondary

End point timeframe

Day 92 (EOS)

End point values	CLL442 2.5 mg/g	Placebo
Number of subjects analysed	30	10
Units: days
median (confidence interval 90%)	99999 (99999 to 99999)	99999 (99999 to 99999)

No statistical analyses for this end point

Secondary: Percentage of Subjects with Complete Clearance at the End of the Study, Assessed Visually and Histologically

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End point title

Percentage of Subjects with Complete Clearance at the End of the Study, Assessed Visually and Histologically

End point description

The PD analysis set included all subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.

End point type

Secondary

End point timeframe

Day 92 (EOS)

End point values	CLL442 2.5 mg/g	Placebo
Number of subjects analysed	25	10
Units: percentage of subjects
number (not applicable)	24.0	20.0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until LPLV (up to Day 92 (EOS)).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.1

Reporting group title

Placebo

Reporting group description

Reporting group title

CLL442 2.5 mg/g

Reporting group description

Serious adverse events	Placebo	CLL442 2.5 mg/g
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 10 (0.00%)	0 / 30 (0.00%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Placebo	CLL442 2.5 mg/g
Total subjects affected by non serious adverse events
subjects affected / exposed	4 / 10 (40.00%)	20 / 30 (66.67%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
subjects affected / exposed	1 / 10 (10.00%)	2 / 30 (6.67%)
occurrences all number	1	2
Vascular disorders
Hypertension
subjects affected / exposed	0 / 10 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	2
General disorders and administration site conditions
Application site erythema
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Application site exfoliation
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	4
Application site oedema
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Application site pain
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	2
Application site pruritus
subjects affected / exposed	0 / 10 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	2
Condition aggravated
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Fatigue
subjects affected / exposed	1 / 10 (10.00%)	0 / 30 (0.00%)
occurrences all number	1	0
Mucosal ulceration
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	2
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Rhinorrhoea
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Psychiatric disorders
Abnormal dreams
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Investigations
Amylase increased
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Electrocardiogram repolarisation abnormality
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Pancreatic enzymes increased
subjects affected / exposed	1 / 10 (10.00%)	0 / 30 (0.00%)
occurrences all number	1	0
Injury, poisoning and procedural complications
Procedural pain
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Sinus bradycardia
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Gastrointestinal disorders
Mouth ulceration
subjects affected / exposed	1 / 10 (10.00%)	1 / 30 (3.33%)
occurrences all number	1	1
Nausea
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Paraesthesia oral
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Oral pain
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	3
Toothache
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Skin and subcutaneous tissue disorders
Actinic keratosis
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Pruritus
subjects affected / exposed	0 / 10 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	2
Rash
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Musculoskeletal and connective tissue disorders
Muscle tightness
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Myalgia
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Neck pain
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Pain in extremity
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Infections and infestations
Pharyngitis
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1
Upper respiratory tract infection
subjects affected / exposed	0 / 10 (0.00%)	6 / 30 (20.00%)
occurrences all number	0	6
Metabolism and nutrition disorders
Polydipsia
subjects affected / exposed	0 / 10 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1

More information

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Were there any global substantial amendments to the protocol? Yes

01 Mar 2018

Amendment was generated in response to request from an Institutional Review Board (IRB) in the United States to add more details in the discontinuation of study treatment for increased-size lesions. Additionally, this amendment also addressed typographical errors to ensure data quality and minimize the risk of inconsistent interpretation.

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

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Clinical trials

Clinical Trial Results:
A randomized, investigator-and patient-blind, placebo controlled, parallel group first in human and proof of concept study to evaluate the safety, tolerability, and efficacy of CLL442 in patients with Cutaneous Squamous Cell Carcinoma in situ (SCCis)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Subjects with Adverse Events (AEs), and Serious Adverse Events (SAEs)

Primary: Number of Subjects with Adverse Events (AEs), and Serious Adverse Events (SAEs)

Primary: Number of Subjects with Local Tolerability Score at Day 7 or Day 84

Primary: Number of Subjects with Local Tolerability Score at Day 7 or Day 84

Primary: Visual Analogue Scale (VAS) Score

Primary: Visual Analogue Scale (VAS) Score

Primary: Change From Baseline in Lesion Area in Subjects with Squamous Cell Carcinoma in situ (SCCis) at Day 84

Primary: Change From Baseline in Lesion Area in Subjects with Squamous Cell Carcinoma in situ (SCCis) at Day 84

Secondary: Plasma Concentration of CLL442

Secondary: Plasma Concentration of CLL442

Secondary: Time Required to Achieve 50% (Partial) Decrease in One Lesion Area

Secondary: Time Required to Achieve 50% (Partial) Decrease in One Lesion Area

Secondary: Time Required to Achieve 10% (Partial) Decrease in One Lesion Area

Secondary: Time Required to Achieve 10% (Partial) Decrease in One Lesion Area

Secondary: Time Required to Achieve Complete (100%) SCCis One Lesion Clearance at the End of the Study

Secondary: Time Required to Achieve Complete (100%) SCCis One Lesion Clearance at the End of the Study

Secondary: Percentage of Subjects with Complete Clearance at the End of the Study, Assessed Visually and Histologically

Secondary: Percentage of Subjects with Complete Clearance at the End of the Study, Assessed Visually and Histologically

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A randomized, investigator-and patient-blind, placebo controlled, parallel group first in human and proof of concept study to evaluate the safety, tolerability, and efficacy of CLL442 in patients with Cutaneous Squamous Cell Carcinoma in situ (SCCis)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Subjects with Adverse Events (AEs), and Serious Adverse Events (SAEs)

Primary: Number of Subjects with Adverse Events (AEs), and Serious Adverse Events (SAEs)

Primary: Number of Subjects with Local Tolerability Score at Day 7 or Day 84

Primary: Number of Subjects with Local Tolerability Score at Day 7 or Day 84

Primary: Visual Analogue Scale (VAS) Score

Primary: Visual Analogue Scale (VAS) Score

Primary: Change From Baseline in Lesion Area in Subjects with Squamous Cell Carcinoma in situ (SCCis) at Day 84

Primary: Change From Baseline in Lesion Area in Subjects with Squamous Cell Carcinoma in situ (SCCis) at Day 84

Secondary: Plasma Concentration of CLL442

Secondary: Plasma Concentration of CLL442

Secondary: Time Required to Achieve 50% (Partial) Decrease in One Lesion Area

Secondary: Time Required to Achieve 50% (Partial) Decrease in One Lesion Area

Secondary: Time Required to Achieve 10% (Partial) Decrease in One Lesion Area

Secondary: Time Required to Achieve 10% (Partial) Decrease in One Lesion Area

Secondary: Time Required to Achieve Complete (100%) SCCis One Lesion Clearance at the End of the Study

Secondary: Time Required to Achieve Complete (100%) SCCis One Lesion Clearance at the End of the Study

Secondary: Percentage of Subjects with Complete Clearance at the End of the Study, Assessed Visually and Histologically

Secondary: Percentage of Subjects with Complete Clearance at the End of the Study, Assessed Visually and Histologically

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
A randomized, investigator-and patient-blind, placebo controlled, parallel group first in human and proof of concept study to evaluate the safety, tolerability, and efficacy of CLL442 in patients with Cutaneous Squamous Cell Carcinoma in situ (SCCis)